Trial Outcomes & Findings for Intraoral Imaging at Clinical Crown Lengthening (NCT NCT03064217)

NCT ID: NCT03064217

Last Updated: 2025-02-07

Results Overview

Changes in pocket depths (the distance from the gingival margin to pocket base) at 12 months from the baseline

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 20 participants
• Primary outcome timeframe: 12 months
• Results posted on: 2025-02-07

Participant Flow

Participant milestones

Measure	Making Impression at Surgery Making impression at surgery Making impression at surgery: Making impression at surgery	Making Impression 8 Weeks After Surgery Making the final impression 8 weeks after surgery
Overall Study STARTED	10	10
Overall Study COMPLETED	10	10
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Measure	Making Impression at Surgery n=10 Teeth Making impression at surgery Making impression at surgery: Making impression at surgery	Making Impression 8 Weeks After Surgery n=10 Teeth Making the final impression 8 weeks after surgery	Total n=20 Teeth Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=10 Participants	0 Participants n=10 Participants	0 Participants n=20 Participants
Age, Categorical Between 18 and 65 years	5 Participants n=10 Participants	9 Participants n=10 Participants	14 Participants n=20 Participants
Age, Categorical >=65 years	5 Participants n=10 Participants	1 Participants n=10 Participants	6 Participants n=20 Participants
Age, Continuous	55.8 years STANDARD_DEVIATION 22 • n=10 Participants	45.5 years STANDARD_DEVIATION 16.6 • n=10 Participants	50.6 years STANDARD_DEVIATION 19.7 • n=20 Participants
Sex: Female, Male Female	6 Participants n=10 Participants	8 Participants n=10 Participants	14 Participants n=20 Participants
Sex: Female, Male Male	4 Participants n=10 Participants	2 Participants n=10 Participants	6 Participants n=20 Participants
Race and Ethnicity Not Collected	—	—	0 Participants Race and Ethnicity were not collected from any participant.
Region of Enrollment United States	10 participants n=10 Participants	10 participants n=10 Participants	20 participants n=20 Participants
Crestal bone loss	1.78 mm STANDARD_DEVIATION 0.8 • n=10 Teeth	1.14 mm STANDARD_DEVIATION 0.7 • n=10 Teeth	1.6 mm STANDARD_DEVIATION 0.7 • n=20 Teeth

PRIMARY outcome

Timeframe: 12 months

Changes in pocket depths (the distance from the gingival margin to pocket base) at 12 months from the baseline

Outcome measures

Measure	Making Impression at Surgery n=10 Participants Making impression at surgery Making impression at surgery: Making impression at surgery	Making Impression 8 Weeks After Surgery n=10 Participants Making the final impression 8 weeks after surgery
Pocket Depth	2.7 mm Standard Deviation 1.2	2.4 mm Standard Deviation 1.0

Adverse Events

Making Impression at Surgery

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Making Impression 8 Weeks After Surgery

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Making Impression at Surgery n=10 participants at risk Making impression at surgery Making impression at surgery: Making impression at surgery	Making Impression 8 Weeks After Surgery n=10 participants at risk Making the final impression 8 weeks after surgery
Nervous system disorders Pain	0.00% 0/10 • 12 months	0.00% 0/10 • 12 months

Additional Information

Se-Lim Oh

University of Maryland, Baltimore

Phone: 4107063708

Email: soh@umaryland.edu

Results disclosure agreements

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