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

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.

Conditions

• Peri-Implantitis
• Periodontal Diseases

Interventions

PROCEDURE

Surgical anti-infective therapy

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

PROCEDURE

Periodontal treatment

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.

PROCEDURE

Oral Hygiene Instruction

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.

DRUG

Triclosan toothpaste

Dental brushing with a toothpaste containing 0.3% triclosan and 1450 ppm sodium fluoride in a regular maintenance program for 24 months.

DRUG

Fluoride toothpaste

Dental brushing with a toothpaste containing 1450 ppm sodium monofluorphosphate in a regular maintenance program for 24 months.

PROCEDURE

Regular maintenance program

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.

Sponsors & Collaborators

• Universidade Estadual de Maringá

  collaborator OTHER

• University of Guarulhos

  lead OTHER

Principal Investigators

• Magda Feres, Professor · Guarulhos University

• Bernal Stewart · Colgate-Palmolive Company

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

70 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2010-06-30

Primary Completion

2014-12-31

Completion

2017-06-30

Countries

• Brazil

Study Locations