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| Name | Class |
|---|---|
| Universidade Estadual de Maringá | OTHER |
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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.
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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Probing Depth (PD) ≥ 5 mm. | Number of sites with Probing Depth (PD) ≥ 5 mm, evaluated in all volunteers. | Baseline, 3, 6, 12, 18, 24 months. |
| PD ≥ 6 mm. | Number of sites with PD ≥ 6 mm, evaluated in all volunteers. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Magda Feres, Professor | Guarulhos University | Study Director |
| Bernal Stewart | Colgate-Palmolive Company | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| State University of Maringa | Maringa | Santa Catarina | 87020-900 | Brazil | ||
| Guarulhos University |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 4267951 | Background | 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. | |
| 19335091 | Background | 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. |
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March 2017
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| 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. |
|
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| 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. |
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| 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. |
|
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| Fluoride toothpaste | Drug | Dental brushing with a toothpaste containing 1450 ppm sodium monofluorphosphate in a regular maintenance program for 24 months. |
|
|
| 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. |
|
|
| Baseline, 3, 6, 12, 18, 24 months. |
| PD ≥ 7 mm. | Number of sites with PD ≥ 7 mm, evaluated in all volunteers. | Baseline, 3, 6, 12, 18, 24 months. |
| Full-mouth PD. | Mean of the PD evaluated in all the periodontal sites from all volunteers. | Baseline, 3, 6, 12, 18, 24 months. |
| Full-mouth CAL. | Mean of the CAL evaluated in all the periodontal sites from all volunteers. | Baseline, 3, 6, 12, 18, 24 months. |
| Bleeding on Probing (BOP). | Percentage of sites with bleeding on probing (BOP), evaluated in all volunteers. | Baseline, 3, 6, 12, 18, 24 months. |
| Plaque accumulation. | Percentage of sites with plaque accumulation, evaluated in all volunteers. | Baseline, 3, 6, 12, 18, 24 months. |
| Marginal bleeding. | Percentage of sites with marginal bleeding. | Baseline, 3, 6, 12, 18, 24 months. |
| Sites gaining CAL ≥ 2mm. | Percentage of sites gaining ≥ 2mm of CAL. | Baseline - 24 months. |
| Sites loosing CAL ≥ 2mm | Percentage of sites loosing ≥ 2mm of CAL | Baseline - 24 months. |
| Radiographic Bone Height | Mean values of radiographic bone height | Baseline, 3, 6, 12, 18, 24 months. |
| BOP reduction | Reduction in the percentage of sites exhibiting BOP. | Baseline - 24 months. |
| Adverse effects | Occurrence of nausea and irritability obtained through a questionnaire of adverse effects | 3, 6, 12, 18, 24 months. |
| Proportions of periodontal pathogenic bacterial species. | Proportions of periodontal pathogenic bacterial species in subgingival biofilm samples. | Baseline, 3, 6, 12, 18, 24 months. |
| Counts of periodontal pathogenic bacterial species. | Proportions of periodontal pathogenic bacterial species in subgingival biofilm samples. | Baseline, 3, 6, 12, 18, 24 months. |
| Guarulhos |
| São Paulo |
| 07023-070 |
| Brazil |
| 26701919 | Background | 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. |
| 25495683 | Background | 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. |
| 19186963 | Background | 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. |
| 25123773 | Background | 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. |
| 20403112 | Background | 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. |
| 24660207 | Background | 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. |
| 22092831 | Background | 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. |
| 27335316 | Background | 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. |
| 18724855 | Background | 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. |
| 23062130 | Background | 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. |
| 16583598 | Background | 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. |
| 7833043 | Background | Socransky SS, Smith C, Martin L, Paster BJ, Dewhirst FE, Levin AE. "Checkerboard" DNA-DNA hybridization. Biotechniques. 1994 Oct;17(4):788-92. |
| 20447259 | Background | 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. |
| 25639948 | Background | 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. |
| 16583596 | Background | 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. |
| 18724856 | Background | 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. |
| 10477976 | Result | 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. |
| 21269037 | Result | 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. |
| 19711612 | Result | 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. |
| 24310847 | Result | 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. |
| 9442423 | Result | 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. |
| 20831669 | Result | 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. |
| 30328176 | Derived | 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. |
| ID | Term |
|---|---|
| D057873 | Peri-Implantitis |
| D010510 | Periodontal Diseases |
| D010518 | Periodontitis |
| ID | Term |
|---|---|
| D009059 | Mouth Diseases |
| D009057 | Stomatognathic Diseases |
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| ID | Term |
|---|---|
| D010512 | Periodontal Index |
| D014260 | Triclosan |
| D005459 | Fluorides |
| D008283 | Maintenance |
| ID | Term |
|---|---|
| D003753 | Dental Health Surveys |
| D006306 | Health Surveys |
| D011795 | Surveys and Questionnaires |
| D003625 | Data Collection |
| D004812 | Epidemiologic Methods |
| D008919 | Investigative Techniques |
| D003813 | Dentistry |
| D010517 | Periodontics |
| D017531 | Health Care Evaluation Mechanisms |
| D011787 | Quality of Health Care |
| D017530 | Health Care Quality, Access, and Evaluation |
| D011634 | Public Health |
| D004778 | Environment and Public Health |
| D011636 | Public Health Dentistry |
| D010647 | Phenyl Ethers |
| D004987 | Ethers |
| D009930 | Organic Chemicals |
| D010636 | Phenols |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D000838 | Anions |
| D007477 | Ions |
| D004573 | Electrolytes |
| D007287 | Inorganic Chemicals |
| D006858 | Hydrofluoric Acid |
| D017611 | Fluorine Compounds |
| D005159 | Health Care Facilities Workforce and Services |
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