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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Bioresorbable membrane will be used as the control | Other | Bioresorbable membrane alone (control) |
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| laser with bioresorabable membrane (test) | Experimental |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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) |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| 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 |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| School of Dentistry ,Department of Periodontics,The University of Texas Health Science Center, Houston | Houston | Texas | 77030 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 18062108 | Background | 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. | |
| 16805685 | 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. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Bioresorbable Membrane Will be Used as the Control | Bioresorbable membrane (control) bioresorbable membrane with laser will be used for regeneration of the periodontium: bioresorbable membrane with laser will be used for regeneration of the periodontium(test) |
| FG001 | Laser With Bioresorabable Membrane (Test) |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| At Baseline and 6 months |
| 3164333 | 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. |
| 2170618 | 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. |
| 19388956 | 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. |
| 17555412 | 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. |
| 775048 | 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. |
| 6568444 | Background | Darley M. Students in Sweden. Nurs Stand (1984). 1984 Nov 22;(374):8. No abstract available. |
bioresorbable membrane with laser will be used for regeneration of the periodontium: bioresorbable membrane with laser will be used for regeneration of the periodontium(test) |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Bioresorbable Membrane Will be Used as the Control | Bioresorbable membrane (control) bioresorbable membrane with laser will be used for regeneration of the periodontium: bioresorbable membrane with laser will be used for regeneration of the periodontium(test) |
| BG001 | Laser With Bioresorabable Membrane (Test) | bioresorbable membrane with laser will be used for regeneration of the periodontium: bioresorbable membrane with laser will be used for regeneration of the periodontium(test) |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
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| Sex: Female, Male | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Posted | Mean | Standard Deviation | mm | At Baseline and 6 months |
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| Secondary | 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. | Posted | Mean | Standard Deviation | mm | At Baseline and 6 months |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Bioresorbable Membrane Will be Used as the Control | Bioresorbable membrane (control) bioresorbable membrane with laser will be used for regeneration of the periodontium: bioresorbable membrane with laser will be used for regeneration of the periodontium(test) | 0 | 14 | 0 | 14 | ||
| EG001 | Laser With Bioresorabable Membrane (Test) | bioresorbable membrane with laser will be used for regeneration of the periodontium: bioresorbable membrane with laser will be used for regeneration of the periodontium(test) | 0 | 17 | 0 | 17 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Rosemary Thomas, DMD, MS | The University of Texas Health Science Center at Houston | 713-486-4074 | rosemary.thomas@uth.tmc.edu |
| ID | Term |
|---|---|
| D017823 | Furcation Defects |
| D010518 | Periodontitis |
| ID | Term |
|---|---|
| D010510 | Periodontal Diseases |
| D009059 | Mouth Diseases |
| D009057 | Stomatognathic Diseases |
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| >=65 years |
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| Male |
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