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

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ClinicalTrials.gov Identifier: NCT03191721
Recruitment Status : Completed
First Posted : June 19, 2017
Last Update Posted : June 19, 2017
Sponsor:
Collaborator:
Universidade Estadual de Maringá
Information provided by (Responsible Party):
Belén Retamal-Valdes, 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.

Condition or disease Intervention/treatment Phase
Peri-Implantitis Periodontal Diseases Procedure: Surgical anti-infective therapy Procedure: Periodontal treatment Procedure: Oral Hygiene Instruction Drug: Triclosan toothpaste Drug: Fluoride toothpaste Procedure: Regular maintenance program Phase 3

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 102 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary Purpose: Treatment
Official Title: Effects of a Toothpaste Containing 0.3% Triclosan in the Maintenance Phase of Peri-implantitis Treatment.
Actual Study Start Date : June 2010
Actual Primary Completion Date : December 2014
Actual Study Completion Date : June 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Test: 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.

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
Other Name: Pre-baseline phase - surgery

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.
Other Name: Pre-baseline phase - SRP

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.
Other Name: OHI

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.
Other Name: Triclosan

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.
Other Name: Maintenance

Placebo Comparator: Control: 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.

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
Other Name: Pre-baseline phase - surgery

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.
Other Name: Pre-baseline phase - SRP

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.
Other Name: OHI

Drug: Fluoride toothpaste
Dental brushing with a toothpaste containing 1450 ppm sodium monofluorphosphate in a regular maintenance program for 24 months.
Other Name: Fluoride

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.
Other Name: Maintenance




Primary Outcome Measures :
  1. Clinical Attachment Level (CAL) at 24 months. [ Time Frame: 24 months ]
    Difference between groups for the change in Clinical Attachment Level (CAL) from baseline to 24 months.


Secondary Outcome Measures :
  1. Probing Depth (PD) ≥ 5 mm. [ Time Frame: Baseline, 3, 6, 12, 18, 24 months. ]
    Number of sites with Probing Depth (PD) ≥ 5 mm, evaluated in all volunteers.

  2. PD ≥ 6 mm. [ Time Frame: Baseline, 3, 6, 12, 18, 24 months. ]
    Number of sites with PD ≥ 6 mm, evaluated in all volunteers.

  3. PD ≥ 7 mm. [ Time Frame: Baseline, 3, 6, 12, 18, 24 months. ]
    Number of sites with PD ≥ 7 mm, evaluated in all volunteers.

  4. Full-mouth PD. [ Time Frame: Baseline, 3, 6, 12, 18, 24 months. ]
    Mean of the PD evaluated in all the periodontal sites from all volunteers.

  5. Full-mouth CAL. [ Time Frame: Baseline, 3, 6, 12, 18, 24 months. ]
    Mean of the CAL evaluated in all the periodontal sites from all volunteers.

  6. Bleeding on Probing (BOP). [ Time Frame: Baseline, 3, 6, 12, 18, 24 months. ]
    Percentage of sites with bleeding on probing (BOP), evaluated in all volunteers.

  7. Plaque accumulation. [ Time Frame: Baseline, 3, 6, 12, 18, 24 months. ]
    Percentage of sites with plaque accumulation, evaluated in all volunteers.

  8. Marginal bleeding. [ Time Frame: Baseline, 3, 6, 12, 18, 24 months. ]
    Percentage of sites with marginal bleeding.

  9. Sites gaining CAL ≥ 2mm. [ Time Frame: Baseline - 24 months. ]
    Percentage of sites gaining ≥ 2mm of CAL.

  10. Sites loosing CAL ≥ 2mm [ Time Frame: Baseline - 24 months. ]
    Percentage of sites loosing ≥ 2mm of CAL

  11. Radiographic Bone Height [ Time Frame: Baseline, 3, 6, 12, 18, 24 months. ]
    Mean values of radiographic bone height

  12. BOP reduction [ Time Frame: Baseline - 24 months. ]
    Reduction in the percentage of sites exhibiting BOP.

  13. Adverse effects [ Time Frame: 3, 6, 12, 18, 24 months. ]
    Occurrence of nausea and irritability obtained through a questionnaire of adverse effects

  14. Proportions of periodontal pathogenic bacterial species. [ Time Frame: Baseline, 3, 6, 12, 18, 24 months. ]
    Proportions of periodontal pathogenic bacterial species in subgingival biofilm samples.

  15. Counts of periodontal pathogenic bacterial species. [ Time Frame: Baseline, 3, 6, 12, 18, 24 months. ]
    Proportions of periodontal pathogenic bacterial species in subgingival biofilm samples.



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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03191721


Locations
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Brazil
State University of Maringa
Maringa, Santa Catarina, Brazil, 87020-900
Guarulhos University
Guarulhos, São Paulo, Brazil, 07023-070
Sponsors and Collaborators
University of Guarulhos
Universidade Estadual de Maringá
Investigators
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Study Director: Magda Feres, Professor Guarulhos University
Study Chair: Bernal Stewart Colgate-Palmolive Company

Publications of Results:
Other Publications:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Belén Retamal-Valdes, DDS, MSc, PhD Student, University of Guarulhos
ClinicalTrials.gov Identifier: NCT03191721     History of Changes
Other Study ID Numbers: CAAE - 0007.0.132.000-10
First Posted: June 19, 2017    Key Record Dates
Last Update Posted: June 19, 2017
Last Verified: June 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: March 2017

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Belén Retamal-Valdes, University of Guarulhos:
Peri-implantitis
Triclosan
Toothpastes
Therapeutics
Periodontal Diseases
Periodontitis
Dentifrices
Additional relevant MeSH terms:
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Triclosan
Fluorides
Periodontal Diseases
Peri-Implantitis
Mouth Diseases
Stomatognathic Diseases
Anti-Infective Agents
Cariostatic Agents
Protective Agents
Physiological Effects of Drugs
Anti-Infective Agents, Local
Fatty Acid Synthesis Inhibitors
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents