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

NCT01522131 | Completed Results

• 1 other identifier: HSC-DB-11-0611
• Study Type: interventional
• Target: 33
• Locations: 1 country
• Sites: 1

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.

Conditions

Furcation Defects; Periodontitis; Alveolar Bone Loss Beyond Furcation

Keywords

bioresorbable membrane

Outcome Measures

Primary Outcomes (1)

• 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.

  At Baseline and 6 months

Secondary Outcomes (1)

• Clinical Evidence of Regeneration of Class 2 Furcation Defects Based on Changes in Vertical Pocket Depth Measurement(in mm)

  At Baseline and 6 months

Study Arms (2)

Bioresorbable membrane will be used as the control

OTHER

Bioresorbable membrane alone (control)

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

laser with bioresorabable membrane (test)

EXPERIMENTAL

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

Interventions

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

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

Bioresorbable membrane will be used as the control; laser with bioresorabable membrane (test)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• The University of Texas Health Science Center, Houston: lead

Study Sites (1)

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

Houston, Texas, 77030, United States

Location

Related Publications (8)

• 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.

  PMID: 18062108 BACKGROUND

• 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.

  PMID: 16805685 BACKGROUND

• 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.

  PMID: 3164333 BACKGROUND

• 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.

  PMID: 2170618 BACKGROUND

• 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.

  PMID: 19388956 BACKGROUND

• 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.

  PMID: 17555412 BACKGROUND

• 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.

  PMID: 775048 BACKGROUND

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

  PMID: 6568444 BACKGROUND

MeSH Terms

Conditions

Furcation Defects; Periodontitis

Condition Hierarchy (Ancestors)

Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases

Results Point of Contact

• Title: Rosemary Thomas, DMD, MS
• Organization: The University of Texas Health Science Center at Houston

rosemary.thomas@uth.tmc.edu

713-486-4074

Study Officials

• Robin L Weltman, DDS,MSD

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

  STUDY DIRECTOR

• Robin L Weltman, DDS,MSD

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

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Resident,Department of Periodontics ,School of Dentistry

Study Record Dates

• First Submitted: January 24, 2012
• First Posted: January 31, 2012
• Study Start: December 1, 2011
• Primary Completion: June 1, 2013
• Study Completion: June 1, 2013
• Last Updated: June 12, 2014
• Results First Posted: June 12, 2014

Record last verified: 2014-03

Locations

US (1)