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

NCT ID: NCT01522131

Last Updated: 2014-06-12

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 33 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-12-31
• Study Completion Date: 2013-06-30

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.

Conditions

Furcation Defects; Periodontitis; Alveolar Bone Loss Beyond Furcation

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Bioresorbable membrane will be used as the control

Bioresorbable membrane alone (control)

Group Type: OTHER

bioresorbable membrane alonewill be used for regeneration of the periodontium(control)

Intervention Type: PROCEDURE

bioresorbable membrane with laser will be used for regeneration of the periodontium(test)

laser with bioresorabable membrane (test)

Group Type: EXPERIMENTAL

bioresorbable membrane alonewill be used for regeneration of the periodontium(control)

Intervention Type: PROCEDURE

bioresorbable membrane with laser will be used for regeneration of the periodontium(test)

Interventions

bioresorbable membrane alonewill be used for regeneration of the periodontium(control)

bioresorbable membrane with laser will be used for regeneration of the periodontium(test)

Intervention Type: PROCEDURE

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)

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

The University of Texas Health Science Center, Houston

OTHER

Sponsor Role: lead

Responsible Party

Rosemary Thomas

Resident,Department of Periodontics ,School of Dentistry

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Robin L Weltman, DDS,MSD

Role: STUDY_DIRECTOR

School of Dentistry ,Department of Periodontics,The University of Texas Health Science Center, Houston

Robin L Weltman, DDS,MSD

Role: STUDY_CHAIR

School of Dentistry ,Department of Periodontics,The University of Texas Health Science Center, Houston

Locations

School of Dentistry ,Department of Periodontics,The University of Texas Health Science Center, Houston

Houston, Texas, United States

Countries

United States

References

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.

Reference Type: BACKGROUND

PMID: 18062108 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 16805685 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 3164333 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 2170618 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 19388956 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 17555412 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 775048 (View on PubMed)

Darley M. Students in Sweden. Nurs Stand (1984). 1984 Nov 22;(374):8. No abstract available.

Reference Type: BACKGROUND

PMID: 6568444 (View on PubMed)

Other Identifiers

HSC-DB-11-0611

Identifier Type: -

Identifier Source: org_study_id