Periodontal Disease Clinical Trial
Verified date | March 2014 |
Source | University of Sao Paulo |
Contact | n/a |
Is FDA regulated | No |
Health authority | Brazil: National Committee of Ethics in Research |
Study type | Interventional |
This clinical study compared a conventional surgical technique (CST) and a minimally invasive surgical technique (MIST) in the regenerative treatment of mandibular furcation defects.
Status | Completed |
Enrollment | 15 |
Est. completion date | December 2013 |
Est. primary completion date | November 2013 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: (I) subjects with a diagnosis of periodontitis; (II) presence of one pair of contralateral mandibular molars with buccal / lingual furcation defects; (III) non-smokers; (IV) plaque index < 20%. Exclusion Criteria: (I) patients that presented systemic disease; (II) had taken antibiotics in the past 6 months prior to surgery; (III) pregnant women or lactating mothers; (IV) molars with periapical disease; (V) cervical restorations or prosthesis closer than 1 mm to fornix; (VI) lingual furcation defects presenting gingival recession (GR) |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Double Blind (Investigator, Outcomes Assessor), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Brazil | Department of Oral & Maxillofacial Surgery and Periodontology, School of Dentistry of Ribeirao Preto, University of Sao Paulo | Ribeirao Preto | Sao Paulo |
Lead Sponsor | Collaborator |
---|---|
University of Sao Paulo |
Brazil,
Cortellini P, Prato GP, Tonetti MS. The modified papilla preservation technique. A new surgical approach for interproximal regenerative procedures. J Periodontol. 1995 Apr;66(4):261-6. — View Citation
Cortellini P, Tonetti MS. A minimally invasive surgical technique with an enamel matrix derivative in the regenerative treatment of intra-bony defects: a novel approach to limit morbidity. J Clin Periodontol. 2007 Jan;34(1):87-93. — View Citation
Cortellini P, Tonetti MS. Focus on intrabony defects: guided tissue regeneration. Periodontol 2000. 2000 Feb;22:104-32. Review. — View Citation
Cortellini P, Tonetti MS. Microsurgical approach to periodontal regeneration. Initial evaluation in a case cohort. J Periodontol. 2001 Apr;72(4):559-69. — View Citation
Cortellini P, Tonetti MS. Minimally invasive surgical technique and enamel matrix derivative in intra-bony defects. I: Clinical outcomes and morbidity. J Clin Periodontol. 2007 Dec;34(12):1082-8. Epub 2007 Oct 22. — View Citation
Döri F, Arweiler NB, Szántó E, Agics A, Gera I, Sculean A. Ten-year results following treatment of intrabony defects with an enamel matrix protein derivative combined with either a natural bone mineral or a ß-tricalcium phosphate. J Periodontol. 2013 Jun;84(6):749-57. doi: 10.1902/jop.2012.120238. Epub 2012 Aug 8. — View Citation
Hammarström L, Heijl L, Gestrelius S. Periodontal regeneration in a buccal dehiscence model in monkeys after application of enamel matrix proteins. J Clin Periodontol. 1997 Sep;24(9 Pt 2):669-77. — View Citation
Hammarström L. Enamel matrix, cementum development and regeneration. J Clin Periodontol. 1997 Sep;24(9 Pt 2):658-68. Review. — View Citation
Heijl L. Periodontal regeneration with enamel matrix derivative in one human experimental defect. A case report. J Clin Periodontol. 1997 Sep;24(9 Pt 2):693-6. — View Citation
Martin M, Gantes B, Garrett S, Egelberg J. Treatment of periodontal furcation defects. (I). Review of the literature and description of a regenerative surgical technique. J Clin Periodontol. 1988 Apr;15(4):227-31. Review. — View Citation
Polimeni G, Xiropaidis AV, Wikesjö UM. Biology and principles of periodontal wound healing/regeneration. Periodontol 2000. 2006;41:30-47. Review. — View Citation
Tonetti MS, Fourmousis I, Suvan J, Cortellini P, Brägger U, Lang NP; European Research Group on Periodontology (ERGOPERIO). Healing, post-operative morbidity and patient perception of outcomes following regenerative therapy of deep intrabony defects. J Clin Periodontol. 2004 Dec;31(12):1092-8. — View Citation
Tsao YP, Neiva R, Al-Shammari K, Oh TJ, Wang HL. Factors influencing treatment outcomes in mandibular Class II furcation defects. J Periodontol. 2006 Apr;77(4):641-6. — View Citation
Wang HL, Greenwell H, Fiorellini J, Giannobile W, Offenbacher S, Salkin L, Townsend C, Sheridan P, Genco RJ; Research, Science and Therapy Committee. Periodontal regeneration. J Periodontol. 2005 Sep;76(9):1601-22. Review. — View Citation
* Note: There are 14 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Digital subtraction radiography density gain | The radiographs were obtained with the paralleling technique employing an x-ray unit and a digital sensor . Customized radiographic holders for each patient . Digital subtraction radiographs (DSR) were performed using a specific software. All pairs of baseline and 6-month radiographs for each treated site were then subtracted. Standardized regions of interest (ROIs) were select for each subtracted digital image: (1) placed in the bone's most coronal and central aspect of the furcation defect; and (2) placed at a distant untreated site acting as a radiographic control. The ROIs were not superimposed on any portion of the tooth surface. A software (Image Tool for Windows, Version 3.0, USA) was used to assess radiographic density changes that occurred in ROIs. |
baseline and 6 months | No |
Primary | Horizontal clinical attachment level (HCAL) | The clinical measure HCAL was assessed and recorded by an experienced periodontist, blinded to the procedures to assess the efficacy of surgical procedures. | baseline and 6 months after surgical procedure | Yes |
Secondary | Pain Scores on the Visual Analogue Scale | 7 days after surgery | No | |
Secondary | Discomfort Scores on the Visual Analogue Scale | 7 days after surgery | No | |
Secondary | Edema Scores on the Visual Analogue Scale | 7 days after surgery | No | |
Secondary | Hematoma Scores on the Visual Analogue Scale | 7 days after surgery | No | |
Secondary | Root Hypersensitivity Scores on the Visual Analogue Scale | 7 days after surgery | No | |
Secondary | Daily Activities Interference Scores on the Visual Analogue Scale | 7 days after surgery | No | |
Secondary | Vertical clinical attachment level (VCAL) | The clinical measure HCAL was assessed and recorded by an experienced periodontist, blinded to the procedures to assess the efficacy of surgical procedures. | baseline and 6 months | No |
Secondary | Probing pocket depth (PPD) | The clinical measure HCAL was assessed and recorded by an experienced periodontist, blinded to the procedures to assess the efficacy of surgical procedures | baseline and 6 months | No |
Secondary | Gingival recession | The clinical measure HCAL was assessed and recorded by an experienced periodontist, blinded to the procedures to assess the efficacy of surgical procedures | baseline and 6 months | No |
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