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Clinical Trial Summary

Purpose: The proposed study will evaluate and compare the clinical response of using bioresorbable collagen membrane alone or defect debridement with erbium Laser irradiation in conjunction with bioresorbable collagen membrane in the treatment of Class II furcation defects in maxillary and mandibular teeth. The study will examine whether there is a superior regeneration potential when the laser energy is combined with membrane defect isolation.

Procedure: The study will use 2 groups, a control group and a test group with 16 patients in each group, with severe chronic periodontitis having clinical or radiographic evidence of Class II furcation defects in the buccal or lingual of the mandibular molars or Class II furcation defects on the buccal of maxillary molars. 16 patients will serve as the control group and open flap debridement with bioresorbable collagen membrane will be the mode of treatment. Group 2: 16 patients will serve as the test group and will undergo open flap debridement in conjunction with Er, Cr: YSGG laser irradiation and a bioresorbable collagen membrane will be used.


Clinical Trial Description

All subjects will be patients of record in the Graduate Periodontics clinic at the UT School of Dentistry. These individuals will have already been diagnosed with chronic periodontitis and require surgical intervention to treat the disease process. All patients will have received initial periodontal therapy consisting of oral hygiene instructions and scaling and root planing. Once enrolled in the study, all subjects will receive surgical therapy involving opened flap debridement of the affected furcation defects along with membrane isolation of the defect. The test group will have debridement performed with the Er,Cr:YSGG laser and ultrasonic cleansing, while the control group will have hand instrumentation along with ultrasonic cleansing. This procedure will take approximately 1.5 hours. Postoperative appointments at 1,2,4,8 weeks requiring 15-30 minutes per appointment; at 3 months for periodontal maintenance and reinforcement of home care requiring 45 minutes; and at 6 months for periodontal maintenance, reassessment of the furcation defect and correction of residual defects requiring 75 minutes. Patients will be exited from the study 2 weeks after the last maintenance appointment and placed on recall with the Department of Periodontics dental hygienist. The total time commitment for each patient is 6 months. ;


Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment


Related Conditions & MeSH terms


NCT number NCT01522131
Study type Interventional
Source The University of Texas Health Science Center, Houston
Contact
Status Completed
Phase N/A
Start date December 2011
Completion date June 2013

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