Alveolar Bone Loss Beyond Furcation, Furcation Defects, Periodontitis
Conditions
Keywords
bioresorbable membrane
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.
Interventions
PROCEDUREbioresorbable membrane alonewill be used for regeneration of the periodontium(control)
bioresorbable membrane with laser will be used for regeneration of the periodontium(test)
Sponsors
The University of Texas Health Science Center, Houston
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Clinical Attachment( Gain or Loss) Measured by Horizontal Clinical Attachment Loss(in mm) From Baseline to 6 Months. | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Clinical Evidence of Regeneration of Class 2 Furcation Defects Based on Changes in Vertical Pocket Depth Measurement(in mm) | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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) | 14 |
| 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) | 17 |
| Total | 31 |
Baseline characteristics
| Characteristic | Bioresorbable Membrane Will be Used as the Control | Laser With Bioresorabable Membrane (Test) | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 1 Participants | 3 Participants | 4 Participants |
| Age, Categorical Between 18 and 65 years | 13 Participants | 14 Participants | 27 Participants |
| Region of Enrollment United States | 14 participants | 17 participants | 31 participants |
| Sex: Female, Male Female | 8 Participants | 12 Participants | 20 Participants |
| Sex: Female, Male Male | 6 Participants | 5 Participants | 11 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 14 | 0 / 17 |
| serious Total, serious adverse events | 0 / 14 | 0 / 17 |
Outcome results
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.
Time frame: At Baseline and 6 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Bioresorbable Membrane Will be Used as the Control | Change in Clinical Attachment( Gain or Loss) Measured by Horizontal Clinical Attachment Loss(in mm) From Baseline to 6 Months. | -.82 mm | Standard Deviation 1.54 |
| Laser With Bioresorabable Membrane (Test) | Change in Clinical Attachment( Gain or Loss) Measured by Horizontal Clinical Attachment Loss(in mm) From Baseline to 6 Months. | -1.26 mm | Standard Deviation 1.96 |
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.
Time frame: At Baseline and 6 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Bioresorbable Membrane Will be Used as the Control | Clinical Evidence of Regeneration of Class 2 Furcation Defects Based on Changes in Vertical Pocket Depth Measurement(in mm) | -.79 mm | Standard Deviation 125 |
| Laser With Bioresorabable Membrane (Test) | Clinical Evidence of Regeneration of Class 2 Furcation Defects Based on Changes in Vertical Pocket Depth Measurement(in mm) | -.88 mm | Standard Deviation 121 |