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

NCT03191721 | Completed Phase 3

• 1 other identifier: CAAE - 0007.0.132.000-10
• Study Type: interventional
• Target: 102
• Locations: 1 country
• Sites: 2

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.

Conditions

Peri-Implantitis; Periodontal Diseases

Keywords

Peri-implantitis; Triclosan; Toothpastes; Therapeutics; Periodontal Diseases; Periodontitis; Dentifrices

Outcome Measures

Primary Outcomes (1)

• Clinical Attachment Level (CAL) at 24 months.

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

  24 months

Secondary Outcomes (15)

• Probing Depth (PD) ≥ 5 mm.

  Baseline, 3, 6, 12, 18, 24 months.

• PD ≥ 6 mm.

  Baseline, 3, 6, 12, 18, 24 months.

• PD ≥ 7 mm.

  Baseline, 3, 6, 12, 18, 24 months.

• Full-mouth PD.

  Baseline, 3, 6, 12, 18, 24 months.

• Full-mouth CAL.

  Baseline, 3, 6, 12, 18, 24 months.

Study Arms (2)

Test: Triclosan toothpaste

EXPERIMENTAL

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.

Procedure: Surgical anti-infective therapy; Procedure: Periodontal treatment; Procedure: Oral Hygiene Instruction; Drug: Triclosan toothpaste; Procedure: Regular maintenance program

Control: Fluoride toothpaste

PLACEBO COMPARATOR

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.

Procedure: Surgical anti-infective therapy; Procedure: Periodontal treatment; Procedure: Oral Hygiene Instruction; Drug: Fluoride toothpaste; Procedure: Regular maintenance program

Interventions

Surgical anti-infective therapy PROCEDURE

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

Also known as: Pre-baseline phase - surgery

Control: Fluoride toothpaste; Test: Triclosan toothpaste

Periodontal treatment PROCEDURE

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.

Also known as: Pre-baseline phase - SRP

Control: Fluoride toothpaste; Test: Triclosan toothpaste

Oral Hygiene Instruction PROCEDURE

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.

Also known as: OHI

Control: Fluoride toothpaste; Test: Triclosan toothpaste

Triclosan toothpaste DRUG

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

Also known as: Triclosan

Test: Triclosan toothpaste

Fluoride toothpaste DRUG

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

Also known as: Fluoride

Control: Fluoride toothpaste

Regular maintenance program PROCEDURE

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.

Also known as: Maintenance

Control: Fluoride toothpaste; Test: Triclosan toothpaste

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Guarulhos: lead
• Universidade Estadual de Maringá: collaborator

Study Sites (2)

State University of Maringa

Maringa, Santa Catarina, 87020-900, Brazil

Location

Guarulhos University

Guarulhos, São Paulo, 07023-070, Brazil

Location

Related Publications (25)

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  PMID: 30328176 DERIVED

MeSH Terms

Conditions

Peri-Implantitis; Periodontal Diseases; Periodontitis

Interventions

Periodontal Index; Triclosan; Fluorides; Maintenance

Condition Hierarchy (Ancestors)

Mouth Diseases; Stomatognathic Diseases

Intervention Hierarchy (Ancestors)

Dental Health Surveys; Health Surveys; Surveys and Questionnaires; Data Collection; Epidemiologic Methods; Investigative Techniques; Dentistry; Periodontics; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health; Public Health Dentistry; Phenyl Ethers; Ethers; Organic Chemicals; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Anions; Ions; Electrolytes; Inorganic Chemicals; Hydrofluoric Acid; Fluorine Compounds; Health Care Facilities Workforce and Services

Study Officials

• Magda Feres, Professor

  Guarulhos University

  STUDY DIRECTOR

• Bernal Stewart

  Colgate-Palmolive Company

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: DDS, MSc, PhD Student

Study Record Dates

• First Submitted: June 8, 2017
• First Posted: June 19, 2017
• Study Start: June 1, 2010
• Primary Completion: December 1, 2014
• Study Completion: June 1, 2017
• Last Updated: June 19, 2017

Record last verified: 2017-06

Data Sharing

• IPD Sharing: Will share

Locations

BR (2)