Infant orthopedics and facial appearance: a randomized clinical trial (Dutchcleft).

OBJECTIVE: To study the effect of infant orthopedics on facial appearance. DESIGN: Prospective two-arm randomized controlled trial in parallel with three participating academic cleft palate centers. Treatment allocation was concealed and performed by means of a computerized balanced allocation method. SETTING: Cleft Palate Centers of Amsterdam, Nijmegen, and Rotterdam, the Netherlands. PATIENTS: Infants with complete unilateral cleft lip and palate, no other malformations. Interventions: One group (IO(+)) wore passive maxillary plates during the first year, the other group (IO(-)) did not. MAIN OUTCOME MEASURE(S): Two metrical response modalities were used (i.e., visual analog scales and reference scores) to score facial appearance. Full face and cropped photographs were compared with reference photographs and were judged. The photographs were judged by 45 judges, 24 laypeople, and 21 professionals. Transformation of the scores into z scores was applied to compare and to pool both response modalities. The validity of each individual judge was evaluated, as was the reliability of the scales. Differences between the treatment groups were evaluated by means of t tests. RESULTS: Photographs were available of 41 subjects, 21 with and 20 without infant orthopedics. No significant differences were found between groups. Mean z-score values for the full-face photographs were: group IO(+) = 0.10 (SD = 0.73) and group IO(-) = -0.03 (SD = 0.48); for the cropped photographs were: group IO(+) = 0.12 (SD = 0.71) and group IO(-) = -0.06 (SD = 0.55). CONCLUSIONS: Infant orthopedics have no effect on facial appearance.     

Presurgical orthopedics and satisfaction in motherhood: a randomized clinical trial (Dutchcleft).

OBJECTIVE: To study the effect of infant orthopedics on satisfaction in motherhood. DESIGN: Prospective two-arm randomized controlled trial in parallel with three participating academic cleft palate centers. Treatment allocation was concealed and was performed by means of a computerized balanced allocation method. Setting: Cleft palate centers of Amsterdam, Nijmegen, and Rotterdam, the Netherlands. PATIENTS: Two groups of infants with complete unilateral cleft lip and palate and no other malformations. INTERVENTIONS: Group IO+ (n = 27) wore passive maxillary plates during the first year of life, group IO- (n = 27) did not. MAIN OUTCOME MEASURE(S): Mean satisfaction scores were obtained from completed questionnaires at 6, 24, and 58 weeks of age. A 4-point scale was used (1 = very satisfactory to 4 = very unsatisfactory). RESULTS: The range of the mean scores for the individual items on the questionnaires for both groups ranged between 1.1 and 2.4. No differences were found between groups. Mothers appear to be satisfied in motherhood, least satisfied with the available time for themselves, and very satisfied with hugging and walking their babies. No differences were found between groups. CONCLUSIONS: Results from the present study show that infant orthopedics, with a passive plate during the first year of life, in children with a unilateral cleft lip and palate has no influence on the mothers' satisfaction in motherhood.     

A randomized prospective clinical trial of the effect of infant orthopedics in unilateral cleft lip and palate: prevention of collapse of the alveolar segments (Dutchcleft).

OBJECTIVE: To study the effect of infant orthopedics (IO) on maxillary arch form and position of the alveolar segments. DESIGN: Prospective two-arm randomized, controlled trial in parallel with three participating academic cleft palate centers. Treatment was assigned by means of a computerized balanced allocation method. Setting: Cleft palate centers of Amsterdam, Nijmegen, and Rotterdam, the Netherlands. PATIENTS, PARTICIPANTS: Infants with complete unilateral cleft lip and palate and no other malformations. Interventions: One group (IO+) wore passive maxillary plates during the first year of life; the other group (IO-) did not. All other interventions were the same. MAIN OUTCOME MEASURE(S): The presence of contact and/or overlap (collapse) between the maxillary segments at maxillary casts made shortly after birth, at 15, 24, 48, 58, and 78 weeks. Survival experience of contact and collapse with time as well as the frequencies of different arch forms and severity of collapse were evaluated. RESULTS: Comparable arch forms with no contact or overlap of the maxillary segments were seen at birth in both groups. With time the frequency of collapse increased, with no significant differences between groups. No significant group differences were found with respect to the survival experience of contact and collapse or for the severity of collapse at the end of the observational period. CONCLUSIONS: Infant orthopedics does not prevent collapse and can be abandoned as a tool to improve maxillary arch form.     

Infant orthopedics has no effect on maxillary arch dimensions in the deciduous dentition of children with complete unilateral cleft lip and palate (Dutchcleft).

OBJECTIVE: Evaluation of the effect of infant orthopedics on maxillary arch dimensions in the deciduous dentition in patients with unilateral cleft lip and palate. DESIGN: Prospective two-arm randomized controlled clinical trial with three participating cleft palate centers. SETTING: Cleft palate centers of the Radboud University Nijmegen Medical Center, Academic Center of Dentistry Amsterdam, and University Medical Center Rotterdam, the Netherlands. PATIENTS: Children with complete unilateral cleft lip and palate (n = 54) were included. INTERVENTIONS: Patients were randomly divided into two groups. Half of the patients (IO+) had a presurgical orthopedic plate until surgical closure of the soft palate at the age of 52 weeks; the other half (IO-) did not undergo presurgical orthopedics. MEAN OUTCOME MEASURES: Maxillary arch dimensions were assessed on dental casts at 4 and 6 years of age with measurements for arch width, arch depth, arch length, arch form, and the vertical position of the lesser segment. Contact and collapse were assessed also. RESULTS: There were no clinically significant differences found between IO+ and IO- for any of the variables. CONCLUSIONS: Infant orthopedics had no observable effect on the maxillary arch dimensions or on the contact and collapse scores in the deciduous dentition at the ages of 4 and 6 years. Considering the Dutchcleft results to date, there is no need to perform infant orthopedics for unilateral cleft lip and palate patients.     

The effect of infant orthopedics on the occlusion of the deciduous dentition in children with complete unilateral cleft lip and palate (Dutchcleft).

OBJECTIVE: Evaluation of the effect of infant orthopedics (IO) on the occlusion of the deciduous dentition in patients with unilateral cleft lip and palate (UCLP). DESIGN: Prospective, two-arm, randomized, controlled clinical trial with three participating cleft palate centers (Dutchcleft). SETTING: Cleft Palate Centers of the University Medical Center Nijmegen, Academic Center of Dentistry Amsterdam, and Dijkzigt University Hospital Rotterdam, The Netherlands. PATIENTS: Children with complete UCLP (n = 54) were included. INTERVENTIONS: In a concealed allocation procedure, half of the patients was randomized to wear a plate till surgical closure of the soft palate (IO+), and the other half (IO-) did not have a plate. MEAN OUTCOME MEASURES: Dental arch relationships were assessed at 4 and 6 years of age with the 5-year-old index; the Huddart-score; and measurements of overjet, overbite, and sagittal occlusion. RESULTS: There were no significant differences found between the IO+ and IO- groups for the 5-year-old index; the Huddart-score; and overjet, overbite, and sagittal occlusion. CONCLUSIONS: IO had no observable effect on the occlusion in the deciduous dentition at 4 and 6 years of age. Considering the occlusion only, there is no need to perform IO in children with UCLP.     

Cost-effectiveness of infant orthopedic treatment regarding speech in patients with complete unilateral cleft lip and palate: a randomized three-center trial in the Netherlands (Dutchcleft).

OBJECTIVE: To investigate the cost-effectiveness of infant orthopedic treatment (IO), compared with no such treatment in children with complete unilateral cleft lip and palate (UCLP) focusing on the effects on speech development at age 2.5 years. DESIGN: In a three-center prospective, randomized clinical trial (Dutchcleft), two groups of children with complete UCLP were followed longitudinally: one group was treated with IO based on a modified Zurich approach in the first year of life (IO group) and the other group did not receive this treatment (non-IO group). PATIENTS: The participants had complete UCLP without soft tissue bands or other malformations. They were born at term and their parents were native Dutch speakers. OUTCOME MEASURES: The effect of IO on speech development at age 2.5 years was measured blindly by five expert listeners judging the "total impression of speech quality" on a 10-point equal-appearing interval scale. Costs were measured from a societal viewpoint in Euro. RESULTS AND CONCLUSION: The IO group (n = 10) obtained a statistically significant higher rating, compared with the non-IO group (n = 10). The effect size was large, indicating that the improvement may be considered a clinically important change. The cost for treatment by the orthodontist was higher in the IO group. For both groups, the mean cost was related to the mean rating for "total impression of speech quality." The resulting cost-effectiveness for IO, compared to non-IO was 1041 for 1.34 point speech quality improvement. The financial investment that is necessary to obtain this improvement seems limited. Thus, from the perspective of speech development, the cost-effectiveness of IO over non-IO seems acceptable at this point in time.     

A randomized control trial investigating the effect of presurgical orthopedics on feeding in infants with cleft lip and/or palate.

OBJECTIVE: To investigate the controversial assertion that presurgical orthopedics (PSO) facilitate feeding in infants with cleft lip and palate. DESIGN: Randomized control trial of 34 infants with nonsyndromic complete unilateral cleft lip and palate and 16 with cleft of the soft and at least two thirds of the hard palate. Allocation to receive presurgical orthopedics or not used minimization for parity and gender. Other aspects of care were standardized. SETTING: The North Thames Regional Cleft Centre. MAIN OUTCOME MEASURES: Measurements were made at 3 months of age (presurgery) and at 12 months of age (postsurgery). Primary outcomes were anthropometry and oral motor skills. Objective measures of sucking also were collected at 3 months using the Great Ormond Street Measure of Infant Feeding. Twenty-one infants also had videofluoroscopic assessment. RESULTS: At 1 year, all infants had normal oral motor skills and no clear pattern of anthropometric differences emerged. For both cleft groups, infants randomized to presurgical orthopedics were, on average, shorter. The presurgical orthopedics infants were, on average, lighter in the unilateral cleft and lip palate group, but heavier in the isolated cleft palate group. Infants with complete unilateral cleft and lip palate randomized to presurgical orthopedics had lower average body mass index (mean difference PSO-No PSO: -0.45 (95% confidence interval [-1.78, 0.88]), this trend was reversed among infants with isolated cleft palates (mean difference PSO-No PSO: 1.98 [-0.95, 4.91]). None of the differences were statistically significant at either age. CONCLUSIONS: Presurgical orthopedics did not improve feeding efficiency or general body growth within the first year in either group of infants.     

Non-participation in a randomized controlled trial: the effect on clinical and non-clinical variables

Studies reporting clinical and non-clinical parameters of participants and non-participants of clinical trials are scarce. In the available studies non-participants were likely to show less favourable outcomes than participants on both socioeconomic parameters as well as on caries experience. However, the impact of non-participation on the total sample of the research population is not established. In the present study, as part of baseline data collection for a randomized controlled trial on caries-preventive strategies, 346 parents of children 6.0 years (± 3 months) of age were approached to let their child participate. Sixty parents refused, but 56 of them were willing to fill out the same set of questionnaires and to allow their child to be clinically examined once. Parents from participating children had higher socioeconomic status, were more often of autochthonous origin and scored better on knowledge questions than parents of non-participating children. Furthermore, parents of participating children reported a higher willingness to invest, were more likely to hold on to regular meals and their child had lower levels of plaque compared to non-participating children. Surprisingly, the participating children had higher dmfs scores than the non-participating children. Their care index (fs/ds + fs) was higher than that of non-participating children. Based on the findings of this study, the presumption that non-participating children will show less favourable clinical outcomes cannot be supported. Although participants differed from non-participants, they did not differ from the total population. It is suggested that the external validity of a randomized controlled trial on caries-preventive strategies is not necessarily affected by non-participation bias.     

Language skills of young children with unilateral cleft lip and palate following infant orthopedics: a randomized clinical trial.

OBJECTIVE: To investigate the effects of infant orthopedics (IO) on the language skills of children with complete unilateral cleft lip and palate (UCLP). DESIGN: In a prospective randomized clinical trial (Dutchcleft), two groups of children with complete UCLP were followed up longitudinally: one group was treated with IO based on a modified Zurich approach in the first year of life (IO group); the other group did not receive this treatment (non-IO group). At the ages of 2, 2(1/2), 3, and 6 years, language development was evaluated in 12 children (six IO and six non-IO). Receptive language skills were assessed using the Reynell test. Expressive language skills of the toddlers were evaluated by calculating mean length of utterance (MLU) and mean length of longest utterances (MLLU); in the 6-year-olds, the expressive language skills were measured using standardized Dutch language tests. PATIENTS: The participants had complete UCLP without soft tissue bands or other malformations. RESULTS: IO did not affect the receptive language skills. However, the expressive language measures MLU and MLLU were influenced by IO. At age 2(1/2) and 3 years, the IO group produced longer utterances than the non-IO group. In the follow-up, the difference in expressive language between the two groups was no longer significant. CONCLUSIONS: Children treated with IO during their first year of life produced longer sentences than non-IO children at the ages of 2(1/2) and 3 years. At 6 years of age, both groups presented similar expressive language skills. Hence, IO treatment did not have long-lasting effects on language development.     

A randomised prospective clinical trial into the effect of infant orthopaedics on maxillary arch dimensions in unilateral cleft lip and palate (Dutchcleft)

Aim of the study was to evaluate the effect of infant orthopaedics (IO) on maxillary dimensions in infants with unilateral cleft lip and palate (UCLP). The study design was a prospective two-arm randomised controlled trial in parallel with three participating academic Cleft Palate Centres. Treatment was assigned by means of a computerised balanced allocation method. One group (IO+) wore passive maxillary plates during the first year of life, the other group (IO-) did not. Maxillary casts, made at birth, and at 15, 24, 48, 78 wk were digitised three-dimensionally. Before lip closure alveolar, midpalatal and posterior cleft width reduced significantly more in IO(+) than in IO(-). After lip closure, the alveolar cleft width reduced significantly more in IO(-). Until soft palate closure the slope of the palatal vault flattened significantly by IO. It is concluded that IO only has a temporary effect on maxillary arch dimensions that does not last beyond surgical soft palate closure. Therefore, infant orthopaedics as a tool to improve maxillary arch form could be abandoned. However, other outcome variables like facial and dental appearance, speech outcome, and cost-effectiveness need to be investigated further in order to assess the comprehensive effect of infant orthopaedics.     

Effect of infant orthopedics on facial appearance of toddlers with complete unilateral cleft lip and palate (Dutchcleft)

OBJECTIVE: To evaluate the effect of infant orthopedics (IO) on facial appearance of 54 patients with unilateral cleft lip and palate (UCLP), aged 4 and 6 years. DESIGN: Prospective two-arm randomized controlled clinical trial in three Cleft Palate Centers in the Netherlands (Dutchcleft-trial). INTERVENTIONS: Patients were divided randomly into two groups. Half of the patients (IO+) had a plate until surgical closure of the soft palate at the age of +/- 52 weeks; the other half (IO-) received no intervention. MAIN OUTCOME MEASURES: Facial appearance at 4 and 6 years of age assessed on full face photographs and photographs showing only nose and mouth. Ratings were performed on a VAS-scale by professionals and laymen. RESULTS: At 4 years of age the full face pictures of IO+ children were scored to be more attractive than those of IO- children. However, this difference had disappeared at 6 years of age. At the age of 6, only professionals saw a significant difference on nasolabial photographs between IO+ and IO-. Regression analysis showed a minor effect of occlusion, lip revision, or type of nose reconstruction on the esthetic results. CONCLUSIONS: IO had a positive effect on full facial appearance of UCLP children at the age of 4 years, but at the age of 6, only professionals saw a positive effect of IO on the nasolabial photographs. This is irrelevant for UCLP patients since they deal with laymen in their daily life.     

The effect of fluoride gel use on bleaching sensitivity: a double-blind randomized controlled clinical trial

BACKGROUND: Fluoride has been recognized as a desensitizer; however, no study has addressed its effects to decrease tooth sensitivity when compared with a placebo in a double-blind randomized clinical study. METHODS: The authors divided 30 participants into two groups: one that received a placebo and another that was treated with fluoride. All patients used 16 percent carbamide peroxide (CP) in a custom-fitted tray until their teeth achieved shade A1 or lighter. After daily removal of CP, the patients wore a tray containing either sodium fluoride or placebo for four minutes. The authors statistically analyzed the perception of the intensity of tooth sensitivity and the weekly shade changes for both groups, as well as the intensity of tooth sensitivity (alpha = .05). RESULTS AND CONCLUSIONS: The use of fluoride gel did not affect the whitening efficacy of the CP. The authors observed no difference between the groups receiving the placebo and the fluoride treatment in terms of tooth sensitivity experience (P > .05); however, patients who received the placebo had a higher-intensity tooth sensitivity than that of patients who received the fluoride (P < .001). CLINICAL IMPLICATIONS. The use of 1.23 percent sodium fluoride after each bleaching regimen does not affect the bleaching efficacy of CP. Also, the use of sodium fluoride gel reduces the intensity of tooth sensitivity.     

The effect of subantimicrobial-dose-doxycycline periodontal therapy on serum biomarkers of systemic inflammation: a randomized, double-masked, placebo-controlled clinical trial

BackgroundPeriodontitis has been reported to be associated with coronary artery disease (CAD). Research is needed to determine if therapies that improve periodontal health also reduce systemic measures of inflammation associated with both diseases.MethodsThe study registrar randomly assigned 128 eligible postmenopausal women with chronic periodontitis to a twice-daily regimen of subantimicrobial-dose–doxycycline (SDD) or placebo tablets for two years as an adjunct to periodontal maintenance therapy. Through a supplement to the main trial, in which they investigated alveolar bone and clinical attachment level changes, the authors assayed inflammatory mediators and lipid profiles in baseline, one-year and two-year serum samples. The authors analyzed the data by using generalized estimating equations.ResultsIn the intent-to-treat analysis across two years, SDD treatment reduced median high-sensitivity C-reactive protein (hs-CRP) by 18 percent (primary outcome; P = .02) and reduced serum matrix metalloproteinase (MMP)-9 (92 kilodalton gelatinase; difference in mean scanning units, ?28.44; P < .001), with no significant effect on serum lipids. However, in women more than five years postmenopausal, SDD elevated the level of high-density lipoprotein (HDL) cholesterol (difference in means [milligrams per deciliter], 5.99; P = .01).ConclusionA two-year SDD regimen in postmenopausal women significantly reduced the serum inflammatory biomarkers hs-CRP and MMP-9 and, among women more than five years postmenopausal, increased the HDL cholesterol level.Clinical ImplicationsSDD significantly reduced the systemic inflammatory biomarkers hs-CRP and MMP-9. More research is needed to determine whether SDD has a role in managing the care of patients at risk of developing CAD.     

Effect of MTAD on postoperative discomfort: a randomized clinical trial

The purpose of this study was to compare levels of postoperative discomfort after cleaning and shaping of root canals using two protocols for removal of smear layer. Seventy-three consecutive patients requiring root canal treatment were included. At random, canals were cleaned and shaped with one of the following protocols. In group 1, 5.25% sodium hypochlorite was used as the root canal irrigant. The smear layer was removed by placing 17% EDTA in the canal(s) for 1 min followed by a 5-ml rinse with 5.25% NaOCl. In group 2, canals were irrigated with 1.3% NaOCl; the smear layer was removed by placing MTAD in the canal(s) for 5 min. Access cavities were closed with a sterile cotton pellet and Cavit. The patients recorded degree of discomfort at various time intervals after cleaning and shaping on a visual analogue scale for 1 wk. No significant statistical difference was found in the degree of discomfort between the two groups (p = 0.58).     

The effect of 0.12% chlorhexidine gluconate rinsing on previously plaque-free and plaque-covered surfaces: a randomized, controlled clinical trial

BACKGROUND: Previous in vitro studies showed little bactericidal effect on structured oral biofilm after exposure to chlorhexidine (CHX). In vivo evidence of a CHX effect against structured biofilm is scarce. The purpose of this study was to compare the efficacy of 0.12% CHX gluconate on previously plaque-free and plaque-covered surfaces. METHODS: This study had a single-masked, randomized split-mouth, 21-day experimental gingivitis design including 20 individuals who refrained from all mechanical plaque control methods for 25 days. On day 4 of plaque accumulation, the individuals had two randomized quadrants cleaned; the other two quadrants served as the plaque-covered surfaces. Also, on day 4, the individuals started rinsing with 0.12% CHX gluconate for 21 days. The Quigley and Hein plaque index (PI), gingival index (GI), and gingival crevicular fluid (GCF) volume were assessed at baseline and days 21 and 25. The PI also was assessed at days 4, 11, and 18. RESULTS: Intergroup comparisons showed statistically higher PI throughout the study on the plaque-covered surfaces compared to the plaque-free surfaces. When the inflammatory response over time was analyzed, a statistically greater increase in GI (from 0.21+/-0.02 to 0.93+/-0.03 versus from 0.18+/-0.01 to 0.52+/-0.03 on plaque-covered and plaque-free surfaces, respectively) and GCF volumes (from 48.09 to 94.28 microl versus from 46.94 to 64.99 microl on plaque-covered and plaque-free surfaces, respectively) occurred on plaque-covered surfaces after 21 days of plaque accumulation. CONCLUSIONS: A 0.12% CHX gluconate mouthrinse had little antiplaque and antigingivitis effect on previously plaque-covered surfaces. These results confirm the diminished effect of CHX on structured biofilm and reinforce the necessity of biofilm disruption before the initiation of CHX mouthrinse.