Effect of Laser Use on Guided Tissue Regeneration in Treatment of Molar Teeth With Class 2 Furcation Affected by Periodontitis
Primary Purpose
Furcation Defects, Periodontitis, Alveolar Bone Loss Beyond Furcation
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
bioresorbable membrane alonewill be used for regeneration of the periodontium(control)
Sponsored by
About this trial
This is an interventional treatment trial for Furcation Defects focused on measuring bioresorbable membrane
Eligibility 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)
Sites / Locations
- School of Dentistry ,Department of Periodontics,The University of Texas Health Science Center, Houston
Arms of the Study
Arm 1
Arm 2
Arm Type
Other
Experimental
Arm Label
Bioresorbable membrane will be used as the control
laser with bioresorabable membrane (test)
Arm Description
Bioresorbable membrane alone (control)
Outcomes
Primary Outcome Measures
Change in Clinical Attachment( Gain or Loss) Measured by Horizontal Clinical Attachment Loss(in mm) From Baseline to 6 Months.
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)
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.
Full Information
NCT ID
NCT01522131
First Posted
January 24, 2012
Last Updated
May 13, 2014
Sponsor
The University of Texas Health Science Center, Houston
1. Study Identification
Unique Protocol Identification Number
NCT01522131
Brief Title
Effect of Laser Use on Guided Tissue Regeneration in Treatment of Molar Teeth With Class 2 Furcation Affected by Periodontitis
Official Title
Treatment of Class II Furcation Defects in the Maxillary and Mandibular Molars With Bioresorbable Collagen Membrane and Laser
Study Type
Interventional
2. Study Status
Record Verification Date
March 2014
Overall Recruitment Status
Completed
Study Start Date
December 2011 (undefined)
Primary Completion Date
June 2013 (Actual)
Study Completion Date
June 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
The University of Texas Health Science Center, Houston
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Furcation Defects, Periodontitis, Alveolar Bone Loss Beyond Furcation
Keywords
bioresorbable membrane
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
33 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Bioresorbable membrane will be used as the control
Arm Type
Other
Arm Description
Bioresorbable membrane alone (control)
Arm Title
laser with bioresorabable membrane (test)
Arm Type
Experimental
Intervention Type
Procedure
Intervention Name(s)
bioresorbable membrane alonewill be used for regeneration of the periodontium(control)
Intervention Description
bioresorbable membrane with laser will be used for regeneration of the periodontium(test)
Primary Outcome Measure Information:
Title
Change in Clinical Attachment( Gain or Loss) Measured by Horizontal Clinical Attachment Loss(in mm) From Baseline to 6 Months.
Description
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.
Time Frame
At Baseline and 6 months
Secondary Outcome Measure Information:
Title
Clinical Evidence of Regeneration of Class 2 Furcation Defects Based on Changes in Vertical Pocket Depth Measurement(in mm)
Description
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.
Time Frame
At Baseline and 6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Robin L Weltman, DDS,MSD
Organizational Affiliation
School of Dentistry ,Department of Periodontics,The University of Texas Health Science Center, Houston
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Robin L Weltman, DDS,MSD
Organizational Affiliation
School of Dentistry ,Department of Periodontics,The University of Texas Health Science Center, Houston
Official's Role
Study Chair
Facility Information:
Facility Name
School of Dentistry ,Department of Periodontics,The University of Texas Health Science Center, Houston
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
18062108
Citation
Gaspirc B, Skaleric U. Clinical evaluation of periodontal surgical treatment with an Er:YAG laser: 5-year results. J Periodontol. 2007 Oct;78(10):1864-71. doi: 10.1902/jop.2007.070054.
Results Reference
background
PubMed Identifier
16805685
Citation
Crespi R, Romanos GE, Cassinelli C, Gherlone E. Effects of Er:YAG laser and ultrasonic treatment on fibroblast attachment to root surfaces: an in vitro study. J Periodontol. 2006 Jul;77(7):1217-22. doi: 10.1902/jop.2006.050416.
Results Reference
background
PubMed Identifier
3164333
Citation
Pontoriero R, Lindhe J, Nyman S, Karring T, Rosenberg E, Sanavi F. Guided tissue regeneration in degree II furcation-involved mandibular molars. A clinical study. J Clin Periodontol. 1988 Apr;15(4):247-54. doi: 10.1111/j.1600-051x.1988.tb01578.x.
Results Reference
background
PubMed Identifier
2170618
Citation
Lekovic V, Kenney EB, Carranza FA Jr, Danilovic V. Treatment of class II furcation defects using porous hydroxylapatite in conjunction with a polytetrafluoroethylene membrane. J Periodontol. 1990 Sep;61(9):575-8. doi: 10.1902/jop.1990.61.9.575.
Results Reference
background
PubMed Identifier
19388956
Citation
Ishikawa I, Aoki A, Takasaki AA, Mizutani K, Sasaki KM, Izumi Y. Application of lasers in periodontics: true innovation or myth? Periodontol 2000. 2009;50:90-126. doi: 10.1111/j.1600-0757.2008.00283.x. No abstract available.
Results Reference
background
PubMed Identifier
17555412
Citation
Derdilopoulou FV, Nonhoff J, Neumann K, Kielbassa AM. Microbiological findings after periodontal therapy using curettes, Er:YAG laser, sonic, and ultrasonic scalers. J Clin Periodontol. 2007 Jul;34(7):588-98. doi: 10.1111/j.1600-051X.2007.01093.x.
Results Reference
background
PubMed Identifier
775048
Citation
Melcher AH. On the repair potential of periodontal tissues. J Periodontol. 1976 May;47(5):256-60. doi: 10.1902/jop.1976.47.5.256. No abstract available.
Results Reference
background
PubMed Identifier
6568444
Citation
Darley M. Students in Sweden. Nurs Stand (1984). 1984 Nov 22;(374):8. No abstract available.
Results Reference
background
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Effect of Laser Use on Guided Tissue Regeneration in Treatment of Molar Teeth With Class 2 Furcation Affected by Periodontitis
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