Triclosan Toothpaste in the Maintenance Phase of Peri-implantitis Treatment.
Condition: Peri-Implantitis; Periodontal Diseases
MeSH terms: Periodontal Diseases; Peri-Implantitis
Study type: Interventional
Phase: Phase 3

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.
    

Intervention name(s): Surgical anti-infective therapy; Periodontal treatment; Oral Hygiene Instruction; Triclosan toothpaste; Fluoride toothpaste; Regular maintenance program
Intervention type(s): Procedure; Procedure; Procedure; Drug; Drug; Procedure
Intervention description(s): Two months before randomization, implants with peri-implantitis received surgical anti-infective therapy. After local anesthesia (2% lidocaine with 1:100,000 epinephrine), intrasulcular incisions were done and buccal and lingual full-thickness flaps were dissected. Granulation tissue was removed to expose the implant threads and bone defect. To remove biofilm and calculus, the implant surface was scaled with teflon curettes and decontaminated with bicarbonate jet (Jet Sonic System). The flap was repositioned in the original position and stabilized with interrupted sutures, which were removed after 10 days; Two months before randomization, all subjects received full-mouth supragingival plaque removal and scaling and root planing (SRP), as needed. The SRP was performed in four to six appointments lasting approximately 1 h each, using manual curettes (Hu-Friedy, Chicago, IL, USA) and ultrasonic device (Cavitron Select SPC, Dentsply professional, York, PA, USA) under local anesthesia. The deep sites were scaled throughout the first week and treatment of the entire oral cavity was completed in 14 days.; Delivery of a soft bristle adult toothbrush (Colgate Palmolive, Brazil), dental floss (Colgate Palmolive, Brazil), and interdental toothbrushes (Colgate Palmolive, Brazil) , according to their individual needs at pre-baseline, baseline, 3, 6, 12, 18 and 24 months. Information was given about the importance of keeping an excellent oral hygiene over the course of the study. The subjects were instructed to brush their teeth for one minute twice a day (morning and evening) using only the toothbrush and toothpaste provided.; Dental brushing with a toothpaste containing 0.3% triclosan and 1450 ppm sodium fluoride in a regular maintenance program for 24 months.; Dental brushing with a toothpaste containing 1450 ppm sodium monofluorphosphate in a regular maintenance program for 24 months.; OHI, supragingival and subgingival biofilm removal from teeth and implants, and oral prophylaxis. If the examiner suspected of peri-implant disease progression, periapical radiographs were taken. If the implant showed ≥ 2 mm of bone loss, it was withdrawn from the study to receive additional treatment (e.g. another surgery procedure). Implants showing severe disease progression associated with mobility were removed. Maintenance visits were performed every 3 months.
Other intervention name(s): Pre-baseline phase - surgery; Pre-baseline phase - SRP; OHI; Triclosan; Fluoride; Maintenance
Intervention MeSH terms: Triclosan; Anti-Infective Agents; Fluorides
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary purpose: Treatment
Keywords: Peri-implantitis; Triclosan; Toothpastes; Therapeutics; Periodontal Diseases; Periodontitis; Dentifrices