Trial Outcomes & Findings for A New Therapeutic Approach for Root Coverage (NCT NCT01143610)

Results Overview

Percentage of root coverage determined by: \[area covered\]/\[total area to be covered\] x 100 (in %)

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

15 participants

Primary outcome timeframe

Baseline, 9 months post-operatively

Results posted on

2012-07-24

Participant Flow

Patients both genders, 18-45 years, showing at least one site with gingival recession should attend the Graduation Clinics of Periodontics, School of Dentistry at Bauru-USP, from October to December 2007 for enrollment in a new treatment protocol.

Participants were excluded from the study prior to group assignement in cases of pregnancy, diagnosis of systemic disease or if the patient quit participating.

Participant milestones

Participant milestones
Measure	Newly Forming Bone Miller class I or II deep recessions treated by the newly forming bone technique.	Subepithelial Connective Tissue Graft Miller class I or II deep recessions treated by subepithelial connective tissue graft.
Overall Study STARTED	7	8
Overall Study COMPLETED	7	8
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

A New Therapeutic Approach for Root Coverage

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Newly Forming Bone n=7 Participants Miller class I or II deep recessions treated by the newly forming bone technique.	Subepithelial Connective Tissue Graft n=8 Participants Miller class I or II deep recessions treated by subepithelial connective tissue graft.	Total n=15 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	7 Participants n=5 Participants	8 Participants n=7 Participants	15 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age Continuous	41 years STANDARD_DEVIATION 4.24 • n=5 Participants	41.5 years STANDARD_DEVIATION 2.67 • n=7 Participants	41.26 years STANDARD_DEVIATION 3.39 • n=5 Participants
Sex: Female, Male Female	3 Participants n=5 Participants	2 Participants n=7 Participants	5 Participants n=5 Participants
Sex: Female, Male Male	4 Participants n=5 Participants	6 Participants n=7 Participants	10 Participants n=5 Participants
Region of Enrollment Brazil	7 participants n=5 Participants	8 participants n=7 Participants	15 participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline, 9 months post-operatively

Population: The unity of analysis was the site, since each participant contributed with more than one site for treatment

Percentage of root coverage determined by: \[area covered\]/\[total area to be covered\] x 100 (in %)

Outcome measures

Outcome measures
Measure	Newly Forming Bone n=35 sites Miller class I or II deep recessions treated by the newly forming bone technique.	Subepithelial Connective Tissue Graft n=30 sites Miller class I or II deep recessions treated by subepithelial connective tissue graft.
Percentage of Root Coverage	66 percentage of area covered Interval 40.0 to 90.0	73 percentage of area covered Interval 50.0 to 100.0

SECONDARY outcome

Timeframe: 9 months post-operatively

Population: The unit of analysis was the site, since each participant contributed with more than one site to be treated

Investigation of clinical attachment level, probing depth and reduction of recession depth

Outcome measures

Outcome measures
Measure	Newly Forming Bone n=35 sites Miller class I or II deep recessions treated by the newly forming bone technique.	Subepithelial Connective Tissue Graft n=30 sites Miller class I or II deep recessions treated by subepithelial connective tissue graft.
Gain of Clinical Attachment Level	3.74 mm Standard Deviation 0.26	2.95 mm Standard Deviation 0.19

Adverse Events

Newly Forming Bone

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Subepithelial Connective Tissue Graft

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

Adriana Campos Passanezi Sant'Ana

School of Dentistry at Bauru - USP

Phone: 00 55 14 3235-8278

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place