Triclosan Toothpaste in the Maintenance Phase of Peri-implantitis Treatment.

Phase 3

Completed

• Conditions: Peri-Implantitis; Periodontal Diseases
• Interventions: Procedure: Surgical anti-infective therapy; Procedure: Periodontal treatment; Procedure: Oral Hygiene Instruction; Drug: Fluoride toothpaste; Drug: Triclosan toothpaste; Procedure: Regular maintenance program

• Registration Number: NCT03191721
• Lead Sponsor: University of Guarulhos

Brief Summary

The aim of this study was to evaluate the effects of a dentifrice containing 0.3% triclosan on periodontal and peri-implant parameters in patients, with or without periodontitis, treated for peri-implantitis and that were enrolled in a maintenance phase for two years.

Detailed Description

Although dental implants have a high success rate, the prevalence of peri-implantitis has been rising worldwide. Similarly to periodontitis, peri-implantis are complex infections caused by oral pathogens that colonize the oral cavity tissues. Then, several anti-infective treatments have been proposed to treat peri-implantitis. Although an ideal and definitive therapy has not yet been established, one of the most commonly used protocols is the open-flap mechanical decontamination of the implant surfaces. Nonetheless, it has been well established that after the active treatment phase, it is essential that patients enter a maintenance phase, similarly to that followed by patients who have had periodontitis. One of the main risk indicators for peri-implantitis is poor oral hygiene, so the maintenance phase should include strict control of the supra and submucosal biofilms. Several methods, including the use of dental and interdental brushes, are usually recommended for the mechanical control of biofilm accumulated in implant surfaces; however, many patients are not able to effectively remove this biofilm. Thus, the use of a chemical adjunct to traditional mechanical methods during the maintenance phase of peri-implantitis treatment could improve the long term stability of dental implants. Among the several antimicrobial agents used to control biofilm accumulation in the oral cavity, triclosan is one of the most effective. Therefore, the aim of this study was to evaluate the effects of a dentifrice containing 0.3% triclosan on periodontal and peri-implant parameters in patients, with or without periodontitis, treated for peri-implantitis and that were enrolled in a maintenance phase for two years. Subjects presenting at least one implant with peri-implantitis, received surgical anti-infective therapy consisting of mechanical debridement of the implant surfaces with scalers and sodium bicarbonate jet were entered into the study. Sixty days later (baseline), subjects were randomized into two groups: (i) brushing with a toothpaste containing 0.3% triclosan + 1450 ppm fluoride (test) or (ii) brushing with a toothpaste containing 1450 ppm fluoride (control). Subjects received clinical and microbiological monitoring at baseline, 3, 6, 12, 18 and 24 months post-therapy. 102 subjects were enrolled (test, n= 48; control, n=54) in the study. The results for peri-implant parameters showed that the control group had loss of relative clinical attachment level (CAL) over the course of the study (p\<0.05) while the test group showed stability for this parameter. The difference between groups for CAL change between baseline and 24 months (0.55 mm) was statistically significant (primary outcome variable). The red complex pathogens were only reduced in the test group at 24 months. The periodontal parameters results showed that the test group (n=39) had a greater reduction in the percentage of sites exhibiting bleeding on probing and lower levels of plaque in comparison with the control group (n=49) after 24 months of brushing with the assigned toothpastes (p\<0.05). The mean percentage of sites with probing depth ≥ 5mm was reduced over the course of the study only in the test group (p\<0.05). The data of the present study showed that a toothpaste containing 0.3% triclosan was more effective than a regular fluoride toothpaste in maintaining peri-implant clinical stability and a more beneficial subgingival microbial profile in subjects with or without a history of periodontitis, that have been treated for peri-implantitis and were enrolled in a regular maintenance program for 2 years. In addition, a toothpaste containing 0.3% triclosan was more effective in maintaining a healthier periodontal environment around natural teeth.

Study Timeline

• Study Start: 2010-06
• Primary Completion: 2014-12
• Status Verified: 2017-06
• Study Completion: 2017-06
• Study First Submitted: 2017-06-08
• Study First Submitted QC: 2017-06-16
• Last Update Submitted: 2017-06-16
• Study First Posted: 2017-06-19
• Last Update Posted: 2017-06-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 102

Inclusion Criteria

• aged between 18-70 years;
• general good health;
• minimum of 1 dental implant in function for at least one year with untreated peri-implantitis defined as: probing depth (PD) ≥ 5 mm, bleeding on probing (BOP) or suppuration, radiographic bone loss involving 2 mm from the upper border of the intrabony portion of the implant.

Exclusion Criteria

• untreated periodontitis (defined as ≥ 6 sites with PD ≥ 5 mm);
• periodontal treatment within three months prior to entering the study;
• inability to perform proper supragingival plaque control (e.g. due to improper prosthesis design or lack of skills);
• diabetes;
• pregnancy;
• nursing;
• history of allergies to triclosan, fluoride or any other ingredient of oral care products;
• alcohol or drug abuse;
• any systemic diseases that could affect post-operative healing;
• any systemic diseases that required antibiotic premedication for routine dental therapy;
• long-term use of mouthrinses, anti-inflammatory medications or any other drug that could interfere with the study outcomes within three months prior to entering the study;
• antibiotics use within six months prior to entering the study;
• participation in any other clinical study within three months prior to entering the study.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Test: Triclosan toothpaste	Surgical anti-infective therapy	To brush twice a day with a toothpaste containing 0.3% triclosan and 1450 ppm sodium fluoride in a regular maintenance program for 24 months. Two months earlier, subjects received Surgical anti-infective therapy for implants with peri-implantitis, periodontal treatment and oral hygiene instruction.
Test: Triclosan toothpaste	Periodontal treatment	To brush twice a day with a toothpaste containing 0.3% triclosan and 1450 ppm sodium fluoride in a regular maintenance program for 24 months. Two months earlier, subjects received Surgical anti-infective therapy for implants with peri-implantitis, periodontal treatment and oral hygiene instruction.
Test: Triclosan toothpaste	Oral Hygiene Instruction	To brush twice a day with a toothpaste containing 0.3% triclosan and 1450 ppm sodium fluoride in a regular maintenance program for 24 months. Two months earlier, subjects received Surgical anti-infective therapy for implants with peri-implantitis, periodontal treatment and oral hygiene instruction.
Test: Triclosan toothpaste	Regular maintenance program	To brush twice a day with a toothpaste containing 0.3% triclosan and 1450 ppm sodium fluoride in a regular maintenance program for 24 months. Two months earlier, subjects received Surgical anti-infective therapy for implants with peri-implantitis, periodontal treatment and oral hygiene instruction.
Control: Fluoride toothpaste	Surgical anti-infective therapy	To brush twice a day with a toothpaste containing 1450 ppm sodium monofluorphosphate in a regular maintenance program for 24 months. Two months earlier, subjects received Surgical anti-infective therapy for implants with peri-implantitis, periodontal treatment and oral hygiene instruction.
Control: Fluoride toothpaste	Periodontal treatment	To brush twice a day with a toothpaste containing 1450 ppm sodium monofluorphosphate in a regular maintenance program for 24 months. Two months earlier, subjects received Surgical anti-infective therapy for implants with peri-implantitis, periodontal treatment and oral hygiene instruction.
Control: Fluoride toothpaste	Oral Hygiene Instruction	To brush twice a day with a toothpaste containing 1450 ppm sodium monofluorphosphate in a regular maintenance program for 24 months. Two months earlier, subjects received Surgical anti-infective therapy for implants with peri-implantitis, periodontal treatment and oral hygiene instruction.
Control: Fluoride toothpaste	Fluoride toothpaste	To brush twice a day with a toothpaste containing 1450 ppm sodium monofluorphosphate in a regular maintenance program for 24 months. Two months earlier, subjects received Surgical anti-infective therapy for implants with peri-implantitis, periodontal treatment and oral hygiene instruction.
Control: Fluoride toothpaste	Regular maintenance program	To brush twice a day with a toothpaste containing 1450 ppm sodium monofluorphosphate in a regular maintenance program for 24 months. Two months earlier, subjects received Surgical anti-infective therapy for implants with peri-implantitis, periodontal treatment and oral hygiene instruction.
Test: Triclosan toothpaste	Triclosan toothpaste	To brush twice a day with a toothpaste containing 0.3% triclosan and 1450 ppm sodium fluoride in a regular maintenance program for 24 months. Two months earlier, subjects received Surgical anti-infective therapy for implants with peri-implantitis, periodontal treatment and oral hygiene instruction.

Primary Outcome Measures

Name	Time	Method
Clinical Attachment Level (CAL) at 24 months.	24 months	Difference between groups for the change in Clinical Attachment Level (CAL) from baseline to 24 months.

Secondary Outcome Measures

Name	Time	Method
Probing Depth (PD) ≥ 5 mm.	Baseline, 3, 6, 12, 18, 24 months.	Number of sites with Probing Depth (PD) ≥ 5 mm, evaluated in all volunteers.
PD ≥ 6 mm.	Baseline, 3, 6, 12, 18, 24 months.	Number of sites with PD ≥ 6 mm, evaluated in all volunteers.
Full-mouth CAL.	Baseline, 3, 6, 12, 18, 24 months.	Mean of the CAL evaluated in all the periodontal sites from all volunteers.
PD ≥ 7 mm.	Baseline, 3, 6, 12, 18, 24 months.	Number of sites with PD ≥ 7 mm, evaluated in all volunteers.
Plaque accumulation.	Baseline, 3, 6, 12, 18, 24 months.	Percentage of sites with plaque accumulation, evaluated in all volunteers.
Full-mouth PD.	Baseline, 3, 6, 12, 18, 24 months.	Mean of the PD evaluated in all the periodontal sites from all volunteers.
Bleeding on Probing (BOP).	Baseline, 3, 6, 12, 18, 24 months.	Percentage of sites with bleeding on probing (BOP), evaluated in all volunteers.
Marginal bleeding.	Baseline, 3, 6, 12, 18, 24 months.	Percentage of sites with marginal bleeding.
Sites gaining CAL ≥ 2mm.	Baseline - 24 months.	Percentage of sites gaining ≥ 2mm of CAL.
Sites loosing CAL ≥ 2mm	Baseline - 24 months.	Percentage of sites loosing ≥ 2mm of CAL
Radiographic Bone Height	Baseline, 3, 6, 12, 18, 24 months.	Mean values of radiographic bone height
BOP reduction	Baseline - 24 months.	Reduction in the percentage of sites exhibiting BOP.
Adverse effects	3, 6, 12, 18, 24 months.	Occurrence of nausea and irritability obtained through a questionnaire of adverse effects
Proportions of periodontal pathogenic bacterial species.	Baseline, 3, 6, 12, 18, 24 months.	Proportions of periodontal pathogenic bacterial species in subgingival biofilm samples.
Counts of periodontal pathogenic bacterial species.	Baseline, 3, 6, 12, 18, 24 months.	Proportions of periodontal pathogenic bacterial species in subgingival biofilm samples.

Trial Locations

Locations (2)

Guarulhos University; 🇧🇷 Guarulhos, São Paulo, Brazil

State University of Maringa; 🇧🇷 Maringa, Santa Catarina, Brazil