Effect of Laser Use on Guided Tissue Regeneration in Treatment of Molar Teeth With Class 2 Furcation Affected by Periodontitis

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Rosemary Thomas, The University of Texas Health Science Center, Houston
ClinicalTrials.gov Identifier:
NCT01522131
First received: January 24, 2012
Last updated: May 13, 2014
Last verified: March 2014
  Purpose

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.


Condition Intervention
Furcation Defects
Periodontitis
Alveolar Bone Loss Beyond Furcation
Procedure: bioresorbable membrane alonewill be used for regeneration of the periodontium(control)

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Treatment of Class II Furcation Defects in the Maxillary and Mandibular Molars With Bioresorbable Collagen Membrane and Laser

Further study details as provided by The University of Texas Health Science Center, Houston:

Primary Outcome Measures:
  • Change in Clinical Attachment( Gain or Loss) Measured by Horizontal Clinical Attachment Loss(in mm) From Baseline to 6 Months. [ Time Frame: At Baseline and 6 months ] [ Designated as safety issue: No ]
    Patients with periodontitis lose bone and clinical attachment over a period of time. In both control and test a Nabers probe( curved probe) marked in mm was used to quantify this loss or gain of clinical attachment in a horizontal direction from the cemento-enamel junction to the the most apical extent of the bone at the furcation entrance at baseline and after 6months after the procedure. These measurements were done intrasurgery and before opening of the flaps,again both at initial visit and 6 months after the procedure was done. This measurement will be measured in mm in postive numbers and then will be compared to measurements ( in mm) at intial and baseline. If there is a loss in attachment it will be denoted by negative number. If theres a gain in attachment it will be denoted by a positive number after the comparison.


Secondary Outcome Measures:
  • Clinical Evidence of Regeneration of Class 2 Furcation Defects Based on Changes in Vertical Pocket Depth Measurement(in mm) [ Time Frame: At Baseline and 6 months ] [ Designated as safety issue: No ]
    Patients with periodontitis lose bone and clinical attachment over a period of time in vertical direction also. In both control and test a UNC probe marked in mm was used to quantify this loss or gain of clinical attachment in a vertical direction from the cemento-enamel junction to the most apical extent of the bone at the furcation entrance at baseline and after 6months after the procedure. These measurements were done intrasurgery and before opening of the flaps,again both at initial visit and 6 months after the procedure was done.This measurement will be measured in mm in postive numbers and then will be compared to measurements ( in mm) at intial and baseline. Increase and decrease of vertical probing depth will be noted by a positive number.


Enrollment: 33
Study Start Date: December 2011
Study Completion Date: June 2013
Primary Completion Date: June 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Bioresorbable membrane will be used as the control
Bioresorbable membrane alone (control)
Procedure: bioresorbable membrane alonewill be used for regeneration of the periodontium(control)
bioresorbable membrane with laser will be used for regeneration of the periodontium(test)
Experimental: laser with bioresorabable membrane (test) Procedure: bioresorbable membrane alonewill be used for regeneration of the periodontium(control)
bioresorbable membrane with laser will be used for regeneration of the periodontium(test)

Detailed 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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • should be 18 years of age in good general health
  • should exhibit an O'Leary plaque score of 20% or less after initial therapy
  • class II furcations defects should be present in the buccal of the maxillary molars or buccal or lingual of the mandibular molars
  • tooth mobility should not exceed Miller Class II

Exclusion Criteria:

  • patients who will be excluded include those with known hypersensitivity or allergy to chlorhexidine,
  • uncontrolled diabetics,
  • patients who are immunocompromised,
  • who have taken steroids within 6 months of study enrollment,
  • individuals who are pregnant and heavy smokers (> 10 cigarettes/day)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01522131

Locations
United States, Texas
School of Dentistry ,Department of Periodontics,The University of Texas Health Science Center, Houston
Houston, Texas, United States, 77030
Sponsors and Collaborators
The University of Texas Health Science Center, Houston
Investigators
Study Director: Robin L Weltman, DDS,MSD School of Dentistry ,Department of Periodontics,The University of Texas Health Science Center, Houston
Study Chair: Robin L Weltman, DDS,MSD School of Dentistry ,Department of Periodontics,The University of Texas Health Science Center, Houston
  More Information

Publications:
Responsible Party: Rosemary Thomas, Resident,Department of Periodontics ,School of Dentistry, The University of Texas Health Science Center, Houston
ClinicalTrials.gov Identifier: NCT01522131     History of Changes
Other Study ID Numbers: HSC-DB-11-0611
Study First Received: January 24, 2012
Results First Received: January 14, 2014
Last Updated: May 13, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by The University of Texas Health Science Center, Houston:
bioresorbable membrane

Additional relevant MeSH terms:
Alveolar Bone Loss
Periodontitis
Furcation Defects
Bone Resorption
Bone Diseases
Musculoskeletal Diseases
Periodontal Atrophy
Periodontal Diseases
Mouth Diseases
Stomatognathic Diseases

ClinicalTrials.gov processed this record on July 20, 2014