Trial Outcomes & Findings for Effect of Laser Use on Guided Tissue Regeneration in Treatment of Molar Teeth With Class 2 Furcation Affected by Periodontitis (NCT NCT01522131)

Results Overview

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.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

33 participants

Primary outcome timeframe

At Baseline and 6 months

Results posted on

2014-06-12

Participant Flow

Participant milestones

Participant milestones
Measure	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)	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)
Overall Study STARTED	16	17
Overall Study COMPLETED	14	17
Overall Study NOT COMPLETED	2	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Bioresorbable Membrane Will be Used as the Control n=14 Participants 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)	Laser With Bioresorabable Membrane (Test) n=17 Participants 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)	Total n=31 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	13 Participants n=5 Participants	14 Participants n=7 Participants	27 Participants n=5 Participants
Age, Categorical >=65 years	1 Participants n=5 Participants	3 Participants n=7 Participants	4 Participants n=5 Participants
Sex: Female, Male Female	8 Participants n=5 Participants	12 Participants n=7 Participants	20 Participants n=5 Participants
Sex: Female, Male Male	6 Participants n=5 Participants	5 Participants n=7 Participants	11 Participants n=5 Participants
Region of Enrollment United States	14 participants n=5 Participants	17 participants n=7 Participants	31 participants n=5 Participants

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Bioresorbable Membrane Will be Used as the Control n=14 Participants 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)	Laser With Bioresorabable Membrane (Test) n=17 Participants 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)
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	-1.26 mm Standard Deviation 1.96

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Bioresorbable Membrane Will be Used as the Control n=14 Participants 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)	Laser With Bioresorabable Membrane (Test) n=17 Participants 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)
Clinical Evidence of Regeneration of Class 2 Furcation Defects Based on Changes in Vertical Pocket Depth Measurement(in mm)	-.79 mm Standard Deviation 125	-.88 mm Standard Deviation 121

Adverse Events

Bioresorbable Membrane Will be Used as the Control

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Laser With Bioresorabable Membrane (Test)

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Rosemary Thomas, DMD, MS

The University of Texas Health Science Center at Houston

Phone: 713-486-4074

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place