A Randomized,Double‐Masked Clinical Trial Comparing Four Periodontitis Treatment Strategies: 1‐Year Clinical Results

Background: The benefit of full‐mouth disinfection (FDIS) over traditional scaling and root planing (SRP) remains equivocal, and it is not known whether the use of adjunctive antibiotics may enhance the effect of FDIS. The aim of the present study is to test the hypothesis that there is no difference in the 1‐year clinical outcome of therapy among groups of patients treated with conventional SRP performed over 2 to 3 weeks, or same‐day FDIS, with or without adjunctive metronidazole. Methods: A total of 184 patients with moderate‐to‐severe periodontitis were randomly allocated to one of four treatment groups: 1) FDIS+metronidazole; 2) FDIS+placebo; 3) SRP+metronidazole; or 4) SRP+placebo. Recordings of plaque, bleeding on probing, probing depth (PD), and clinical attachment level (CAL) were carried out in four sites per tooth at baseline and at 3 and 12 months after treatment. Results: No differences were observed in the mean CAL or PD values between the four experimental groups at baseline and 3 or 12 months post‐treatment. All four groups displayed significant improvements in all parameters. However, using absence of pockets ≥5 mm as the criterion for treatment success, the two groups receiving adjunctive metronidazole performed significantly better than the two placebo groups. Conclusion: Metronidazole had a significant, adjunctive effect in patients with a metronidazole‐sensitive subgingival microbiota on the clinical parameters of CAL, PD, and absence of pockets ≥5 mm.     

A Randomized Double‐Masked Clinical Trial Comparing Four Periodontitis Treatment Strategies: 5‐Year Tooth Loss Results

Background: Tooth loss is the ultimate negative consequence of periodontitis, and reports of the extent to which different treatment strategies may influence long‐term tooth loss are hard to find. This study aims to test the hypothesis that there is no difference in 5‐year clinical outcome of therapy in terms of tooth mortality between groups of patients treated with conventional scaling and root planing (SRP) over weeks or same‐day full‐mouth disinfection (FDIS), with or without adjunctive metronidazole (MET). Methods: One hundred eighty‐four patients with moderate‐to‐severe periodontitis were randomly allocated to one of four treatment groups: 1) FDIS+MET; 2) FDIS+placebo; 3) SRP+MET; and 4) SRP+placebo. Total 161 patients (88%) completed the 5‐year follow‐up examination, and data on number and timing of tooth extractions as well as pre‐extraction diagnoses and reasons for extractions were analyzed. Results: No differences were observed between groups with regard to number of, reasons for, or time of extractions in the four groups at baseline and 1, 3, and 5 years after treatment. Conclusion: If extraction or retention of teeth is regarded as a measure of failure or success 5 years after completion of periodontal therapy, none of the four strategies produced an end result better than the other.     

Open‐Flap Versus Flapless Esthetic Crown Lengthening: 12‐Month Clinical Outcomes of a Randomized Controlled Clinical Trial

Background: Excessive gingival display (EGD) has a negative impact on a pleasant smile. Minimally invasive therapeutic modalities have become the standard treatment in many dentistry fields. Therefore, the aim of this study is to compare the clinical outcomes of open‐flap (OF) and minimally invasive flapless (FL) esthetic crown lengthening (ECL) for the treatment of EGD. Methods: A split‐mouth randomized controlled trial was conducted in 28 patients presenting with EGD. Contralateral quadrants received ECL using OF or FL techniques. Clinical parameters were evaluated at baseline and 3, 6, and 12 months post‐surgery. The local levels of receptor activator of nuclear factor‐κB ligand (RANKL) and osteoprotegerin (OPG) were assessed by enzyme‐linked immunosorbent assay at baseline and 3 months. Patients’ perceptions regarding morbidity and esthetic appearance were also evaluated. Periodontal tissue dimensions were obtained by computed tomography at baseline and correlated with the changes in the gingival margin (GM). Results: Patients reported low morbidity and high satisfaction with esthetic appearance for both procedures (P >0.05). RANKL and OPG concentrations were increased in the OF group at 3 months (P <0.05). Probing depths were reduced for both groups at all time points, compared with baseline (P <0.05). There were no differences between groups for GM reduction at any time point (P >0.05). Conclusions: FL and OF surgeries produced stable and similar clinical results up to 12 months. FL ECL may be a predictable alternative approach for the treatment of EGD.     

Periodontal Therapy Effects on Nitrite Related to Oral Bacteria: A 6‐Month Randomized Clinical Trial

Background : Nitrite is a biologic factor relevant to oral and systemic homeostasis. Through an oral bacteria reduction process, it was suggested that periodontal therapy and chlorhexidine (CHX) rinse could affect nitrite levels, leading to negative effects, such as an increase in blood pressure. This 6‐month randomized clinical trial evaluated the effects of periodontal therapeutic protocols on salivary nitrite and its relation to subgingival bacteria. Methods: One hundred patients with periodontitis were allocated randomly to debridement procedures in four weekly sections (quadrant scaling [QS]) or within 24 hours (full‐mouth scaling [FMS]) in conjunction with a 60‐day CHX (QS + CHX and FMS + CHX), placebo (QS + placebo and FMS + placebo), or no mouthrinse (QS + none and FMS + none) use. Real‐time polymerase chain reaction determined total bacterial, Aggregatibacter actinomycetemcomitans, Porphyromonas gingivalis, Tannerella forsythia, Treponema denticola, Streptococcus oralis, and Actinomyces naeslundii levels. Salivary nitrite concentration was determined with Griess reagent. Data were analyzed statistically at baseline and 3 and 6 months by analysis of variance, Kruskal–Wallis, Mann–Whitney U, and Spearman correlation tests (P <0.05). Results: Nitrite concentrations did not tend to change over time. Regarding CHX use, there was a negative correlation between nitrite and total bacterial load at 6 months (FMS + CHX) and one positive correlation between P. gingivalis and nitrite at baseline (QS + CHX). Independently of rinse type, in the FMS group, nitrite correlated negatively with several microbial parameters and also with a higher percentage of deep periodontal pockets. Conclusions: The relationship between nitrite and bacterial levels appears weak. Short‐term scaling exhibited a greater influence on nitrite concentrations then long‐term CHX use.     

Platelet‐Derived Growth Factor Promotes Periodontal Regeneration in Localized Osseous Defects: 36‐Month Extension Results From a Randomized,Controlled, Double‐Masked Clinical Trial

Background: Recombinant human platelet‐derived growth factor (rhPDGF) is safe and effective for the treatment of periodontal defects in short‐term studies up to 6 months in duration. We now provide results from a 36‐month extension study of a multicenter, randomized, controlled clinical trial evaluating the effect and long‐term stability of PDGF‐BB treatment in patients with localized severe periodontal osseous defects. Methods: A total of 135 participants were enrolled from six clinical centers for an extension trial. Eighty‐three individuals completed the study at 36 months and were included in the analysis. The study investigated the local application of β‐tricalcium phosphate scaffold matrix with or without two different dose levels of PDGF (0.3 or 1.0 mg/mL PDGF‐BB) in patients possessing one localized periodontal osseous defect. Composite analysis for clinical and radiographic evidence of treatment success was defined as percentage of cases with clinical attachment level (CAL) ≥2.7 mm and linear bone growth (LBG) ≥1.1 mm. Results: The participants exceeding this composite outcome benchmark in the 0.3 mg/mL rhPDGF‐BB group went from 62.2% at 12 months, 75.9% at 24 months, to 87.0% at 36 months compared with 39.5%, 48.3%, and 53.8%, respectively, in the scaffold control group at these same time points (P <0.05). Although there were no significant increases in CAL and LBG at 36 months among all groups, there were continued increases in CAL gain, LBG, and percentage bone fill over time, suggesting overall stability of the regenerative response. Conclusion: PDGF‐BB in a synthetic scaffold matrix promotes long‐term stable clinical and radiographic improvements as measured by composite outcomes for CAL gain and LBG for patients possessing localized periodontal defects ( ClinicalTrials.gov no. CT01530126).     

A Modified Surgical Technique for Root Coverage With an Allograft: A 12‐Month Randomized Clinical Trial

Background: The aim of this randomized controlled clinical study is to investigate whether a modified surgical technique could provide better results for root coverage and greater amounts of keratinized tissue (KT) with the acellular dermal matrix graft (ADMG). Methods: Fifteen bilateral Miller Class I or II gingival recessions (GRs) were selected. The recessions were treated and assigned randomly to the test group (TG), and the contralateral recessions were assigned to the control group (CG). The ADMG was used in both groups with differences in the graft positioning between them. The following clinical parameters were measured before the surgeries and after 12 months: 1) probing depth; 2) relative clinical attachment level; 3) GR; 4) thickness of KT (TKT); and 5) KT width. A new parameter, the GR area (GRA), was measured in standardized photographs using a special device and software. Results: There was no significant difference between groups in KT width and TKT parameters at the 12‐month postoperative period. However, there was a significant difference between the gains in GR (ΔGR) and GRA (ΔGRA), favoring the TG after 12 months. The TG presented ΔGR = 3.04 ± 0.29 mm and ΔGRA= 38,919 ± 9,238 pixel square values (pix²), and the CG presented ΔGR= 2.61 ± 0.41 mm and ΔGRA= 22,245 ± 9,334 pix² (P <0.05 and <0.001, respectively). Conclusions: Both techniques were successful. The TG treatment was more effective in reducing GR and GRA. The flap and graft position may be of importance in root coverage procedures outcome.     

Clinical Outcomes After Treatment of Non‐Contained Intrabony Defects With Enamel Matrix Derivative or Guided Tissue Regeneration: A 12‐Month Randomized Controlled Clinical Trial

Background: The purpose of this study is to compare the healing of deep, non‐contained intrabony defects (i.e., with a ≥80% 1‐wall component and a residual 2‐ to 3‐wall component in the most apical part) treated with either an enamel matrix derivative (EMD) or guided tissue regeneration (GTR) after 12 months. Methods: In this randomized, controlled clinical trial, 40 subjects with 40 defects affecting single‐rooted teeth were treated. The defects were treated with EMD alone or with a non‐resorbable titanium‐reinforced membrane. No grafting materials were used. At baseline and after 12 months, clinical parameters including probing depths (PDs) and clinical attachment levels (CAL) were recorded. The difference in CAL gain was the primary outcome. Results: At baseline, the intrabony component of the defects amounted to 8.5 ± 2.2 mm at EMD‐treated sites and 8.6 ± 1.7 mm at GTR‐treated sites (P = 0.47). The mean CAL gain at sites treated with GTR was significantly greater (P <0.001) than that at sites treated with EMD (4.1 ± 1.4 mm versus 2.4 ± 2.2 mm, respectively). GTR therapy, compared to EMD application alone, significantly (P = 0.01) increased the probability of CAL gain ≥4 mm (79.2% versus 11.3%, respectively) and significantly (P = 0.01) decreased the probability of residual PDs ≥6 mm (3% versus 79.3%, respectively). Conclusion: Although the outcomes of open‐flap debridement alone were not investigated, the application of EMD alone appeared to yield less PD reduction and CAL gain compared to GTR therapy in the treatment of deep, non‐contained intrabony defects.     

Fresh‐Frozen Bone Blocks for Horizontal Ridge Augmentation in the Upper Maxilla: 6‐Month Outcomes of a Randomized Controlled Trial

Purpose: This randomized controlled trial compared fresh‐frozen versus autologous bone blocks for maxillary horizontal ridge augmentation in patients with Cawood and Howell class IV atrophies. Materials and Methods: Twenty‐four patients were allocated to the autologous and fresh‐frozen groups in a 1:1 ratio. Patients underwent computed tomography scans 1 week and 6 months after surgery for graft volume and density analysis. Doxycycline was administered at day 120 and day 150 to label new bone formation. Biopsy for histologic and histomorphometric analyses was performed at reentry for implant insertion, 6 months after grafting. Results: Fresh‐frozen grafts had lower density than autologous bone. Autologous and fresh‐frozen grafts lost, respectively, 25% and 52% of their initial volume (p = .0041). Histology revealed the presence of newly formed bone within both graft types, but clear signs of inflammation were present in fresh‐frozen blocks. Conclusions: According to these 6‐month results, autologous bone blocks are preferable to fresh‐frozen bone grafts.     

Impact of Platform Switching on Peri‐Implant Bone Remodeling around Short Implants in the Posterior Region, 1‐Year Results from a Split‐Mouth Clinical Trial

Aim: To assess the effect of platform switching on peri‐implant bone remodeling around short implants (8.5 mm) placed in the resorbed posterior mandibular and maxillary region of partially edentulous patients. Materials and Methods: Seventeen patients with one or more missing teeth at both sides in the posterior region were, according to a split‐mouth design, randomly assigned to be treated with a platform‐matched (control) implant on the one side and a platform‐switched implant (test) on the other side. A total of 62 short implants (8.5 mm) with a dual‐acid etched surface with nanometer‐sized calcium phosphate particles was placed. Follow‐up visits were conducted one month and one year after placing the implant crown. Outcome measures were interproximal bone level changes, implant survival and clinical parameters. Results: One year after loading, peri‐implant bone remodeling around test implants (0.53 ± 0.54 mm) was significant less than around control implants (0.85 ± 0.65 mm; p = .003). With regard to implant survival and clinical parameters no significant differences were observed between test and control implants. Conclusions: This study suggested that peri‐implant bone remodeling is affected by platform switching. One year after loading, interproximal bone levels were better maintained at implants restored according to the platform switching concept.     

Influence of the Utilization Time of Different Manual Toothbrushes on Oral Hygiene Assessed During a 6‐Month Observation Period: A Randomized Clinical Trial

Background: The aim of this randomized clinical trial (RCT) was to investigate whether 6‐month continuous use of different manual toothbrushes (TBs) influences plaque removal and the degree of gingival inflammation compared to short utilization periods of 4 weeks each. Methods: In total, 96 participants were randomly allocated into two groups: continuous use during 6 months (non‐renewal group) or a change in TB every 4 weeks during 6 months (renewal group). Each group was subdivided into four subgroups (groups A to H; n = 12 each) according to the head size (normal or short) and bristle hardness (medium or soft) of the TB used. The modified Quigley–Hein plaque index (QHI), papilla bleeding index (PBI), and gingival index (GI) were recorded at baseline and 2, 8, 12, 16, and 24 weeks after baseline. After 24 weeks, each participant received a new TB, and at week 26, the final QHI, PBI, and GI were determined. The statistical evaluation consisted of analysis of covariance (P <0.05). Results: With time, QHI, PBI, and GI were significantly different between the renewal and the non‐renewal groups (QHI: P = 0.02; PBI: P = 0.04; GI: P <0.01), independent of subgroup. In the renewal group, QHI showed a significant decrease between baseline and each follow‐up visit (P <0.01). In the non‐renewal group, there was a significant decrease compared to baseline up to and including week 16 (P <0.01). PBI in the renewal group showed no significant differences between baseline and each follow‐up visit (P >0.05). In the non‐renewal group, only the normal head/soft subgroup exhibited a significant increase at week 24 (P = 0.02). The GI in the renewal group showed no difference between baseline and all follow‐up visits, whereas in the non‐renewal group, there was a significant decrease up to and including week 12 (P <0.05). Conclusions: Six‐month continuous use reduced the effectiveness of the TB with respect to plaque removal, and gingival inflammation appeared to increase.     

Treatment of Non‐Contained Infrabony Defects With Enamel Matrix Derivative Alone or in Combination With Biphasic Calcium Phosphate Bone Graft: A 12‐Month Randomized Controlled Clinical Trial

Background: Use of enamel matrix derivative (EMD) when dealing with non‐contained defects may be limited because EMD does not maintain a space itself. Use of combined therapy has been proposed, using a bone graft in combination with EMD to avoid collapse of the flap into the bony defect during healing time. Therefore, the aim of this study is to evaluate the clinical and radiologic healing response of non‐contained infrabony defects after treatment with a combination of EMD and biphasic calcium phosphate (BC) or EMD alone. Methods: Fifty‐two patients with at least one infrabony defect ≥3 mm in depth with a probing depth (PD) ≥6 mm were randomly treated with EMD/BC or EMD alone. Clinical and radiographic parameters were evaluated at baseline, 6, and 12 months after surgery. To standardize the procedure, an acrylic stent and millimeter radiographic grid were used. The primary outcome was the change in clinical attachment level (CAL). Results: Analysis of the data demonstrated a statistically significant difference from baseline within each group (P <0.05), with a difference in clinical and radiographic parameters at 6 and 12 months. After 1 year, mean PD reductions of 3.14 ± 1.95 mm (39.6%) in the EMD/BC group and 3.30 ± 1.89 mm (48.7%) in the EMD group were achieved. A mean CAL gain of 2.38 ± 2.17 mm (24.9%) in the EMD/BC group and 2.65 ± 2.18 mm (36.2%) in the EMD group were obtained. Reduction in the infrabony component was 2.71 ± 1.79 mm (57.9%) in the test group and 2.60 ± 2.03 mm (28.5%) in the control group. There were no statistically significant differences between treatment groups. Conclusions: It was concluded that treatment of non‐contained infrabony defects with EMD, with or without BC, resulted in statistically significantly better results after 12 months compared with baseline measurements. In contrast, the combined approach did not result in a statistically significant improvement.     

Clinical,Microbial, and Immune Responses Observed in Patients With Diabetes After Treatment for Gingivitis: A Three‐Month Randomized Clinical Trial

Background: Although patients with diabetes are frequently affected by periodontitis, only a few investigations have focused on gingivitis in this at‐risk population. This randomized placebo‐controlled clinical trial compared the response to a gingivitis treatment protocol that combined mechanical procedures and daily use of an essential oil (EO) mouthrinse between patients with and without diabetes. Methods: The whole‐mouth periodontal probing depth (PD), gingival index (GI), and plaque index (PI) were monitored in gingivitis cases among systemically healthy patients (n = 60) or those with diabetes (n = 60) at baseline and 3 months after treatment. Levels of Porphyromonas gingivalis, Tannerella forsythia, Aggregatibacter actinomycetemcomitans, and total bacterial load were determined by a real‐time polymerase chain reaction in intrasulci plaque samples. The volume of gingival crevicular fluid (GCF) was quantified, and interleukin‐1β (IL‐1β) levels were determined in GCF samples. After a full‐mouth ultrasonic debridement, patients were randomly assigned to an EO or a placebo rinse for 90 days (40 mL/day). The data were analyzed through repeated‐measures analysis of variance and multiple comparisons Tukey tests (P <0.05). Results: GI was more severe in the diabetes group. Diabetes impaired GI and reduced GCF volume. PD, bacterial levels, and IL‐1β improved similarly in both systemic conditions. The adjunctive use of EO provided greater reductions of PI, GI, total bacterial load, T. forsythia, A. actinomycetemcomitans, and GCF volume. Conclusions: Response to gingivitis treatment in patients with diabetes can slightly differ from that in patients without diabetes. Daily use of an EO mouthrinse after ultrasonic debridement benefited patients with and without diabetes.     

A 3‐Day Randomized Clinical Trial to Investigate the Desensitizing Properties of Three Dentifrices

Background: The aim of the present study is to evaluate the relative abilities of three desensitizing dentifrices to provide rapid relief of dentin hypersensitivity (DH). Methods: Using a double‐mask, randomized design, three dentifrices: 1) containing 8% arginine and 1,450 ppm sodium monofluorophosphate; 2) containing 8% strontium acetate and 1,040 ppm sodium fluoride; and 3) containing 30% microaggregation of zinc‐carbonate hydroxyapatite nanocrystals were compared after 3‐day treatment. Participant's DH was evaluated at baseline and after 3 days using air‐blast, tactile, cold water, and subjective tests. Results: The final sample consisted of 85 individuals: 29 received the arginine‐based dentifrice (group 1), 27 the strontium acetate–based dentifrice (group 2), and 29 the dentifrice based on zinc‐carbonate hydroxyapatite (group 3). All dentifrices were mostly effective to reduce DH: the percentage of score reduction from baseline to 3 days was >30% for all tests (except for subjective test of group 2). The comparison among the three dentifrices showed that, after 3 days, there was an improvement in air‐blast (mean percentage of reduction, 39.2% in group 1, 42.0% in group 2, and 39.2% in group 3), cold water (41.5%, 51.8%, and 50%), tactile (50.3%, 40.1%, and 33.8%), and subjective (33.1%, 17.4%, and 31.4%) test scores, with differences being significant for cold water and subjective tests. For air‐blast and tactile tests, there were no significant differences across groups at 3 days. Moreover, no significant differences at any test were observed in a subset of patients that were followed up to 8 weeks: all dentifrices were all highly efficacious. Conclusions: This study documents that the three tested dentifrices significantly reduced DH after 3‐day treatment, supporting their use in clinical practice. To the best of the authors’ knowledge, this is the first report documenting the rapid relief from DH of a zinc‐carbonate hydroxyapatite dentifrice.