Trial Outcomes & Findings for Single Stage Root Coverage for Gingival Recession With or Without Free Gingival Graft (NCT NCT03370042)

NCT ID: NCT03370042

Last Updated: 2020-03-11

Results Overview

measured from cemento enamel junction to the most apical part of gingival margin

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 20 participants
• Primary outcome timeframe: 12 months
• Results posted on: 2020-03-11

Participant Flow

Unit of analysis: Recession defects

Participant milestones

Measure	SCPF + FGG semilunar coronally positioned flap with free gingival graft semilunar coronally positioned flap with free gingival graft	SCPF semilunar coronally positioned flap alone semilunar coronally positioned flap alone
Overall Study STARTED	10 10	10 10
Overall Study COMPLETED	10 10	10 10
Overall Study NOT COMPLETED	0 0	0 0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Single Stage Root Coverage for Gingival Recession With or Without Free Gingival Graft

Baseline characteristics by cohort

Measure	SCPF + FGG n=10 Participants semilunar coronally positioned flap with free gingival graft	SCPF n=10 Participants semilunar coronally positioned flap alone	Total n=20 Participants Total of all reporting groups
Age, Customized	32.5 years n=5 Participants	32.5 years n=7 Participants	32.5 years n=5 Participants
Sex: Female, Male Female	2 Participants n=5 Participants	2 Participants n=7 Participants	4 Participants n=5 Participants
Sex: Female, Male Male	8 Participants n=5 Participants	8 Participants n=7 Participants	16 Participants n=5 Participants
Region of Enrollment India	10 participants n=5 Participants	10 participants n=7 Participants	20 participants n=5 Participants

PRIMARY outcome

Timeframe: 12 months

measured from cemento enamel junction to the most apical part of gingival margin

Outcome measures

Measure	SCPF + FGG n=10 Participants semilunar coronally positioned flap with free gingival graft semilunar coronally positioned flap with free gingival graft	SCPF n=10 Participants semilunar coronally positioned flap alone semilunar coronally positioned flap alone
Recession Height	1.0 mm Standard Deviation 1.05	0.9 mm Standard Deviation 0.7

PRIMARY outcome

Timeframe: 12 months

measured from most apical part of gingival recession to the mucogingival junction

Outcome measures

Measure	SCPF + FGG n=10 Participants semilunar coronally positioned flap with free gingival graft semilunar coronally positioned flap with free gingival graft	SCPF n=10 Participants semilunar coronally positioned flap alone semilunar coronally positioned flap alone
Width of Keratinized Tissue	4.7 mm Standard Deviation 1.07	3.6 mm Standard Deviation 0.84

SECONDARY outcome

Timeframe: 12 months

combined probing depth and recession height

Outcome measures

Measure	SCPF + FGG n=10 Participants semilunar coronally positioned flap with free gingival graft semilunar coronally positioned flap with free gingival graft	SCPF n=10 Participants semilunar coronally positioned flap alone semilunar coronally positioned flap alone
Clinical Attachment Level	2.4 mm Standard Deviation 0.9	2.3 mm Standard Deviation 1.05

SECONDARY outcome

Timeframe: 12 months

gingival margin to the base of the sulcus

Outcome measures

Measure	SCPF + FGG n=10 Participants semilunar coronally positioned flap with free gingival graft semilunar coronally positioned flap with free gingival graft	SCPF n=10 Participants semilunar coronally positioned flap alone semilunar coronally positioned flap alone
Probing Depth	1.3 mm Standard Deviation 0.4	1.3 mm Standard Deviation 0.4

SECONDARY outcome

Timeframe: 12 months

mesial gingival margin to distal gingival margin at cemento enamel junction

Outcome measures

Measure	SCPF + FGG n=10 Participants semilunar coronally positioned flap with free gingival graft semilunar coronally positioned flap with free gingival graft	SCPF n=10 Participants semilunar coronally positioned flap alone semilunar coronally positioned flap alone
Recession Width	1.3 mm Standard Deviation 1.3	1.4 mm Standard Deviation 1.07

Adverse Events

SCPF + FGG

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

SCPF

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

Dr. Raga Bindu

Kamineni Institute of dental sciences

Phone: 09849441800

Email: ragha.j16@gmail.com

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place