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

Primary Purpose

Peri-Implantitis, Periodontal Diseases

Status
Completed
Phase
Phase 3
Locations
Brazil
Study Type
Interventional
Intervention
Surgical anti-infective therapy
Periodontal treatment
Oral Hygiene Instruction
Triclosan toothpaste
Fluoride toothpaste
Regular maintenance program
Sponsored by
University of Guarulhos
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Peri-Implantitis focused on measuring Peri-implantitis, Triclosan, Toothpastes, Therapeutics, Periodontal Diseases, Periodontitis, Dentifrices

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • State University of Maringa
  • Guarulhos University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Test: Triclosan toothpaste

Control: Fluoride toothpaste

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

First Posted
June 8, 2017
Last Updated
June 16, 2017
Sponsor
University of Guarulhos
Collaborators
Universidade Estadual de Maringá
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1. Study Identification

Unique Protocol Identification Number
NCT03191721
Brief Title
Triclosan Toothpaste in the Maintenance Phase of Peri-implantitis Treatment.
Official Title
Effects of a Toothpaste Containing 0.3% Triclosan in the Maintenance Phase of Peri-implantitis Treatment.
Study Type
Interventional

2. Study Status

Record Verification Date
June 2017
Overall Recruitment Status
Completed
Study Start Date
June 2010 (Actual)
Primary Completion Date
December 2014 (Actual)
Study Completion Date
June 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Guarulhos
Collaborators
Universidade Estadual de Maringá

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Peri-Implantitis, Periodontal Diseases
Keywords
Peri-implantitis, Triclosan, Toothpastes, Therapeutics, Periodontal Diseases, Periodontitis, Dentifrices

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare Provider
Allocation
Randomized
Enrollment
102 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Test: Triclosan toothpaste
Arm Type
Experimental
Arm Description
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.
Arm Title
Control: Fluoride toothpaste
Arm Type
Placebo Comparator
Arm Description
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.
Intervention Type
Procedure
Intervention Name(s)
Surgical anti-infective therapy
Other Intervention Name(s)
Pre-baseline phase - surgery
Intervention Description
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
Intervention Type
Procedure
Intervention Name(s)
Periodontal treatment
Other Intervention Name(s)
Pre-baseline phase - SRP
Intervention Description
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.
Intervention Type
Procedure
Intervention Name(s)
Oral Hygiene Instruction
Other Intervention Name(s)
OHI
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Triclosan toothpaste
Other Intervention Name(s)
Triclosan
Intervention Description
Dental brushing with a toothpaste containing 0.3% triclosan and 1450 ppm sodium fluoride in a regular maintenance program for 24 months.
Intervention Type
Drug
Intervention Name(s)
Fluoride toothpaste
Other Intervention Name(s)
Fluoride
Intervention Description
Dental brushing with a toothpaste containing 1450 ppm sodium monofluorphosphate in a regular maintenance program for 24 months.
Intervention Type
Procedure
Intervention Name(s)
Regular maintenance program
Other Intervention Name(s)
Maintenance
Intervention Description
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.
Primary Outcome Measure Information:
Title
Clinical Attachment Level (CAL) at 24 months.
Description
Difference between groups for the change in Clinical Attachment Level (CAL) from baseline to 24 months.
Time Frame
24 months
Secondary Outcome Measure Information:
Title
Probing Depth (PD) ≥ 5 mm.
Description
Number of sites with Probing Depth (PD) ≥ 5 mm, evaluated in all volunteers.
Time Frame
Baseline, 3, 6, 12, 18, 24 months.
Title
PD ≥ 6 mm.
Description
Number of sites with PD ≥ 6 mm, evaluated in all volunteers.
Time Frame
Baseline, 3, 6, 12, 18, 24 months.
Title
PD ≥ 7 mm.
Description
Number of sites with PD ≥ 7 mm, evaluated in all volunteers.
Time Frame
Baseline, 3, 6, 12, 18, 24 months.
Title
Full-mouth PD.
Description
Mean of the PD evaluated in all the periodontal sites from all volunteers.
Time Frame
Baseline, 3, 6, 12, 18, 24 months.
Title
Full-mouth CAL.
Description
Mean of the CAL evaluated in all the periodontal sites from all volunteers.
Time Frame
Baseline, 3, 6, 12, 18, 24 months.
Title
Bleeding on Probing (BOP).
Description
Percentage of sites with bleeding on probing (BOP), evaluated in all volunteers.
Time Frame
Baseline, 3, 6, 12, 18, 24 months.
Title
Plaque accumulation.
Description
Percentage of sites with plaque accumulation, evaluated in all volunteers.
Time Frame
Baseline, 3, 6, 12, 18, 24 months.
Title
Marginal bleeding.
Description
Percentage of sites with marginal bleeding.
Time Frame
Baseline, 3, 6, 12, 18, 24 months.
Title
Sites gaining CAL ≥ 2mm.
Description
Percentage of sites gaining ≥ 2mm of CAL.
Time Frame
Baseline - 24 months.
Title
Sites loosing CAL ≥ 2mm
Description
Percentage of sites loosing ≥ 2mm of CAL
Time Frame
Baseline - 24 months.
Title
Radiographic Bone Height
Description
Mean values of radiographic bone height
Time Frame
Baseline, 3, 6, 12, 18, 24 months.
Title
BOP reduction
Description
Reduction in the percentage of sites exhibiting BOP.
Time Frame
Baseline - 24 months.
Title
Adverse effects
Description
Occurrence of nausea and irritability obtained through a questionnaire of adverse effects
Time Frame
3, 6, 12, 18, 24 months.
Title
Proportions of periodontal pathogenic bacterial species.
Description
Proportions of periodontal pathogenic bacterial species in subgingival biofilm samples.
Time Frame
Baseline, 3, 6, 12, 18, 24 months.
Title
Counts of periodontal pathogenic bacterial species.
Description
Proportions of periodontal pathogenic bacterial species in subgingival biofilm samples.
Time Frame
Baseline, 3, 6, 12, 18, 24 months.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Magda Feres, Professor
Organizational Affiliation
Guarulhos University
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Bernal Stewart
Organizational Affiliation
Colgate-Palmolive Company
Official's Role
Study Chair
Facility Information:
Facility Name
State University of Maringa
City
Maringa
State/Province
Santa Catarina
ZIP/Postal Code
87020-900
Country
Brazil
Facility Name
Guarulhos University
City
Guarulhos
State/Province
São Paulo
ZIP/Postal Code
07023-070
Country
Brazil

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
March 2017
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Triclosan Toothpaste in the Maintenance Phase of Peri-implantitis Treatment.

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