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

May 13, 2014 updated by: Rosemary Thomas, The University of Texas Health Science Center, Houston

Treatment of Class II Furcation Defects in the Maxillary and Mandibular Molars With Bioresorbable Collagen Membrane and Laser

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

33

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Texas
      • Houston, Texas, United States, 77030
        • School of Dentistry ,Department of Periodontics,The University of Texas Health Science Center, Houston

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
OTHER: 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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
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.
At Baseline and 6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
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.
At Baseline and 6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2011

Primary Completion (ACTUAL)

June 1, 2013

Study Completion (ACTUAL)

June 1, 2013

Study Registration Dates

First Submitted

January 24, 2012

First Submitted That Met QC Criteria

January 26, 2012

First Posted (ESTIMATE)

January 31, 2012

Study Record Updates

Last Update Posted (ESTIMATE)

June 12, 2014

Last Update Submitted That Met QC Criteria

May 13, 2014

Last Verified

March 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HSC-DB-11-0611

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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