- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03191721
Triclosan Toothpaste in the Maintenance Phase of Peri-implantitis Treatment.
Effects of a Toothpaste Containing 0.3% Triclosan in the Maintenance Phase of Peri-implantitis Treatment.
Study Overview
Status
Conditions
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Phase 3
Contacts and Locations
Study Locations
-
-
Santa Catarina
-
Maringa, Santa Catarina, Brazil, 87020-900
- State University of Maringá
-
-
São Paulo
-
Guarulhos, São Paulo, Brazil, 07023-070
- Guarulhos University
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: DOUBLE
Arms and Interventions
Participant Group / 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. |
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 Names:
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 Names:
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 Names:
Dental brushing with a toothpaste containing 0.3% triclosan and 1450 ppm sodium fluoride in a regular maintenance program for 24 months.
Other Names:
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 Names:
|
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. |
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 Names:
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 Names:
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 Names:
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 Names:
Dental brushing with a toothpaste containing 1450 ppm sodium monofluorphosphate in a regular maintenance program for 24 months.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
24 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
Baseline, 3, 6, 12, 18, 24 months.
|
PD ≥ 6 mm.
Time Frame: Baseline, 3, 6, 12, 18, 24 months.
|
Number of sites with PD ≥ 6 mm, evaluated in all volunteers.
|
Baseline, 3, 6, 12, 18, 24 months.
|
PD ≥ 7 mm.
Time Frame: Baseline, 3, 6, 12, 18, 24 months.
|
Number of sites with PD ≥ 7 mm, evaluated in all volunteers.
|
Baseline, 3, 6, 12, 18, 24 months.
|
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.
|
Baseline, 3, 6, 12, 18, 24 months.
|
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.
|
Baseline, 3, 6, 12, 18, 24 months.
|
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.
|
Baseline, 3, 6, 12, 18, 24 months.
|
Plaque accumulation.
Time Frame: Baseline, 3, 6, 12, 18, 24 months.
|
Percentage of sites with plaque accumulation, evaluated in all volunteers.
|
Baseline, 3, 6, 12, 18, 24 months.
|
Marginal bleeding.
Time Frame: Baseline, 3, 6, 12, 18, 24 months.
|
Percentage of sites with marginal bleeding.
|
Baseline, 3, 6, 12, 18, 24 months.
|
Sites gaining CAL ≥ 2mm.
Time Frame: Baseline - 24 months.
|
Percentage of sites gaining ≥ 2mm of CAL.
|
Baseline - 24 months.
|
Sites loosing CAL ≥ 2mm
Time Frame: Baseline - 24 months.
|
Percentage of sites loosing ≥ 2mm of CAL
|
Baseline - 24 months.
|
Radiographic Bone Height
Time Frame: Baseline, 3, 6, 12, 18, 24 months.
|
Mean values of radiographic bone height
|
Baseline, 3, 6, 12, 18, 24 months.
|
BOP reduction
Time Frame: Baseline - 24 months.
|
Reduction in the percentage of sites exhibiting BOP.
|
Baseline - 24 months.
|
Adverse effects
Time Frame: 3, 6, 12, 18, 24 months.
|
Occurrence of nausea and irritability obtained through a questionnaire of adverse effects
|
3, 6, 12, 18, 24 months.
|
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.
|
Baseline, 3, 6, 12, 18, 24 months.
|
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.
|
Baseline, 3, 6, 12, 18, 24 months.
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Study Director: Magda Feres, Professor, Guarulhos University
- Study Chair: Bernal Stewart, Colgate-Palmolive Company
Publications and helpful links
General Publications
- Cumming BR, Loe H. Consistency of plaque distribution in individuals without special home care instruction. J Periodontal Res. 1973;8(2):94-100. doi: 10.1111/j.1600-0765.1973.tb00756.x. No abstract available.
- de Mendonca AC, Santos VR, Cesar-Neto JB, Duarte PM. Tumor necrosis factor-alpha levels after surgical anti-infective mechanical therapy for peri-implantitis: a 12-month follow-up. J Periodontol. 2009 Apr;80(4):693-9. doi: 10.1902/jop.2009.080521.
- Derks J, Schaller D, Hakansson J, Wennstrom JL, Tomasi C, Berglundh T. Effectiveness of Implant Therapy Analyzed in a Swedish Population: Prevalence of Peri-implantitis. J Dent Res. 2016 Jan;95(1):43-9. doi: 10.1177/0022034515608832.
- Derks J, Tomasi C. Peri-implant health and disease. A systematic review of current epidemiology. J Clin Periodontol. 2015 Apr;42 Suppl 16:S158-71. doi: 10.1111/jcpe.12334.
- Duarte PM, de Mendonca AC, Maximo MB, Santos VR, Bastos MF, Nociti FH. Effect of anti-infective mechanical therapy on clinical parameters and cytokine levels in human peri-implant diseases. J Periodontol. 2009 Feb;80(2):234-43. doi: 10.1902/jop.2009.070672.
- Figuero E, Graziani F, Sanz I, Herrera D, Sanz M. Management of peri-implant mucositis and peri-implantitis. Periodontol 2000. 2014 Oct;66(1):255-73. doi: 10.1111/prd.12049.
- Heitz-Mayfield LJ, Lang NP. Comparative biology of chronic and aggressive periodontitis vs. peri-implantitis. Periodontol 2000. 2010 Jun;53:167-81. doi: 10.1111/j.1600-0757.2010.00348.x.
- Heitz-Mayfield LJ, Mombelli A. The therapy of peri-implantitis: a systematic review. Int J Oral Maxillofac Implants. 2014;29 Suppl:325-45. doi: 10.11607/jomi.2014suppl.g5.3.
- Heitz-Mayfield LJA, Salvi GE, Mombelli A, Faddy M, Lang NP. Anti-infective surgical therapy of peri-implantitis. A 12-month prospective clinical study. Clin Oral Implants Res. 2012 Feb;23(2):205-210. doi: 10.1111/j.1600-0501.2011.02276.x. Epub 2011 Aug 9.
- Heitz-Mayfield LJA, Salvi GE, Mombelli A, Loup PJ, Heitz F, Kruger E, Lang NP. Supportive peri-implant therapy following anti-infective surgical peri-implantitis treatment: 5-year survival and success. Clin Oral Implants Res. 2018 Jan;29(1):1-6. doi: 10.1111/clr.12910. Epub 2016 Jun 23.
- Lindhe J, Meyle J; Group D of European Workshop on Periodontology. Peri-implant diseases: Consensus Report of the Sixth European Workshop on Periodontology. J Clin Periodontol. 2008 Sep;35(8 Suppl):282-5. doi: 10.1111/j.1600-051X.2008.01283.x.
- Mombelli A, Muller N, Cionca N. The epidemiology of peri-implantitis. Clin Oral Implants Res. 2012 Oct;23 Suppl 6:67-76. doi: 10.1111/j.1600-0501.2012.02541.x.
- Panagakos FS, Volpe AR, Petrone ME, DeVizio W, Davies RM, Proskin HM. Advanced oral antibacterial/anti-inflammatory technology: A comprehensive review of the clinical benefits of a triclosan/copolymer/fluoride dentifrice. J Clin Dent. 2005;16 Suppl:S1-19.
- Socransky SS, Smith C, Martin L, Paster BJ, Dewhirst FE, Levin AE. "Checkerboard" DNA-DNA hybridization. Biotechniques. 1994 Oct;17(4):788-92.
- Mestnik MJ, Feres M, Figueiredo LC, Duarte PM, Lira EA, Faveri M. Short-term benefits of the adjunctive use of metronidazole plus amoxicillin in the microbial profile and in the clinical parameters of subjects with generalized aggressive periodontitis. J Clin Periodontol. 2010 Apr;37(4):353-65. doi: 10.1111/j.1600-051X.2010.01538.x.
- Tonetti MS, Eickholz P, Loos BG, Papapanou P, van der Velden U, Armitage G, Bouchard P, Deinzer R, Dietrich T, Hughes F, Kocher T, Lang NP, Lopez R, Needleman I, Newton T, Nibali L, Pretzl B, Ramseier C, Sanz-Sanchez I, Schlagenhauf U, Suvan JE. Principles in prevention of periodontal diseases: Consensus report of group 1 of the 11th European Workshop on Periodontology on effective prevention of periodontal and peri-implant diseases. J Clin Periodontol. 2015 Apr;42 Suppl 16:S5-11. doi: 10.1111/jcpe.12368.
- Xu T, Deshmukh M, Barnes VM, Trivedi HM, Du-Thumm L, Richter R, Cummins D. Analysis of the antibacterial activity and plaque control benefit of colgate total dentifrice via clinical evaluation and real-time polymerase chain reaction. J Clin Dent. 2005;16(4):117-22.
- Zitzmann NU, Berglundh T. Definition and prevalence of peri-implant diseases. J Clin Periodontol. 2008 Sep;35(8 Suppl):286-91. doi: 10.1111/j.1600-051X.2008.01274.x.
- Fine DH, Furgang D, Bonta Y, DeVizio W, Volpe AR, Reynolds H, Zambon JJ, Dunford RG. Efficacy of a triclosan/NaF dentifrice in the control of plaque and gingivitis and concurrent oral microflora monitoring. Am J Dent. 1998 Dec;11(6):259-70.
- Haraszthy VI, Zambon JJ, Sreenivasan PK. Evaluation of the antimicrobial activity of dentifrices on human oral bacteria. J Clin Dent. 2010;21(4):96-100.
- Ramberg P, Lindhe J, Botticelli D, Botticelli A. The effect of a triclosan dentifrice on mucositis in subjects with dental implants: a six-month clinical study. J Clin Dent. 2009;20(3):103-7.
- Riley P, Lamont T. Triclosan/copolymer containing toothpastes for oral health. Cochrane Database Syst Rev. 2013 Dec 5;2013(12):CD010514. doi: 10.1002/14651858.CD010514.pub2.
- Rosling B, Wannfors B, Volpe AR, Furuichi Y, Ramberg P, Lindhe J. The use of a triclosan/copolymer dentifrice may retard the progression of periodontitis. J Clin Periodontol. 1997 Dec;24(12):873-80. doi: 10.1111/j.1600-051x.1997.tb01205.x.
- Sreenivasan PK, Vered Y, Zini A, Mann J, Kolog H, Steinberg D, Zambon JJ, Haraszthy VI, da Silva MP, De Vizio W. A 6-month study of the effects of 0.3% triclosan/copolymer dentifrice on dental implants. J Clin Periodontol. 2011 Jan;38(1):33-42. doi: 10.1111/j.1600-051X.2010.01617.x. Epub 2010 Sep 13.
- Stewart B, Shibli JA, Araujo M, Figueiredo LC, Panagakos F, Matarazzo F, Mairink R, Onuma T, Faveri M, Retamal-Valdes B, Feres M. Effects of a toothpaste containing 0.3% triclosan in the maintenance phase of peri-implantitis treatment: 2-Year randomized clinical trial. Clin Oral Implants Res. 2018 Oct;29(10):973-985. doi: 10.1111/clr.13363.
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Stomatognathic Diseases
- Mouth Diseases
- Periodontal Diseases
- Peri-Implantitis
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Anti-Infective Agents, Local
- Antimetabolites
- Protective Agents
- Hypolipidemic Agents
- Lipid Regulating Agents
- Cariostatic Agents
- Fatty Acid Synthesis Inhibitors
- Fluorides
- Anti-Infective Agents
- Triclosan
Other Study ID Numbers
- CAAE - 0007.0.132.000-10
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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