Trial Outcomes & Findings for A Comparison Between Primary and Secondary Flap Coverage in Extraction Sites: A Pilot Study (NCT NCT03136913)

Results Overview

Models/casts will be made in stone using the impressions. A stent will be made to measure the height and width of the alveolar ridge. Ridge height will be measured before tooth extraction, and 3-5 months after ridge preservation.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

13 participants

Primary outcome timeframe

< 6 months post extraction and ridge preservation

Results posted on

2021-08-12

Participant Flow

Two randomization schemes were created using the statistical package R Version 2.11.1. One randomization scheme was used if the subject has more than 1 set of qualifying sites (the inclusion criteria specify bilateral sites) and randomized which set would be included in the study. The other randomization scheme was used to randomize which side is in Group 1 and which side is in Group 2. The two sites (one set) chosen to be in the study each had a 50% chance of being in either group.

Participant milestones

Participant milestones
Measure	All Study Participants (OFT vs CFT) Open flap technique (OFT) with secondary wound closure (test group) and closed flap technique (CFT) with primary wound closure (control group). OFT with flaps in position for healing by secondary intention CFT with flaps in primary coverage
Overall Study STARTED	13
Overall Study Subjects Received Both Intervention	10
Overall Study COMPLETED	8
Overall Study NOT COMPLETED	5

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

A Comparison Between Primary and Secondary Flap Coverage in Extraction Sites: A Pilot Study

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	All Study Participants (OFT vs CFT) n=10 Participants Open flap technique (OFT) with secondary wound closure (test group) Closed flap technique (CFT) with primary wound closure (control group).
Age, Continuous	56.4 years STANDARD_DEVIATION 9.1 • n=39 Participants
Sex: Female, Male gender · Female	2 Participants n=39 Participants
Sex: Female, Male gender · Male	8 Participants n=39 Participants

PRIMARY outcome

Timeframe: < 6 months post extraction and ridge preservation

Population: 20 sites were analyzed of 10 participants, 10 OFT sites and 10 CFT sites, 1 OFT and 1 CFT for each subject, were analyzed

Models/casts will be made in stone using the impressions. A stent will be made to measure the height and width of the alveolar ridge. Ridge height will be measured before tooth extraction, and 3-5 months after ridge preservation.

Outcome measures

Outcome measures
Measure	OFT vs CFT n=20 site Open flap technique (OFT) with secondary wound closure (test group) and closed flap technique (CFT) with primary wound closure (control group).	Closed Flap Technique Healing by primary intention: Extraction and ridge preservation, utilizing non-resorbable membrane (Cytoplast® TXT-200 ) and freeze dried bone allograft (MinerOss® Cortical and Cancellous Chips (FDBA)), with flaps in primary coverage. Cytoplast® TXT-200: Non-resorbable membrane MinerOss® Cortical and Cancellous Chips (FDBA): Mixture of allograft mineralized cortical and cancellous chips Closed Flap Technique: After extraction, the socket wound is closed by primary closure
Mean Difference in Alveolar Bone Height Change OFT	7.5 mm Standard Deviation 1.8	—
Mean Difference in Alveolar Bone Height Change CFT	8.1 mm Standard Deviation 1.9	—

SECONDARY outcome

Timeframe: Up to 16 days post extraction and ridge preservation

Population: 10 subject received CFT and OFT simultaneously. Post-operative pain/discomfort comparing the two techniques were analyzed

Subjects will be asked to rate their pain/discomfort on a visual analog scale (VAS) questionnaire (scores on a scale of 0-10, 10 to be the worst)

Outcome measures

Outcome measures
Measure	OFT vs CFT n=10 Participants Open flap technique (OFT) with secondary wound closure (test group) and closed flap technique (CFT) with primary wound closure (control group).	Closed Flap Technique n=10 Participants Healing by primary intention: Extraction and ridge preservation, utilizing non-resorbable membrane (Cytoplast® TXT-200 ) and freeze dried bone allograft (MinerOss® Cortical and Cancellous Chips (FDBA)), with flaps in primary coverage. Cytoplast® TXT-200: Non-resorbable membrane MinerOss® Cortical and Cancellous Chips (FDBA): Mixture of allograft mineralized cortical and cancellous chips Closed Flap Technique: After extraction, the socket wound is closed by primary closure
Post-operative Pain/Discomfort 2 weeks	0.4 VAS(scale 0-10), scores on a scale Standard Deviation 0.5	0.8 VAS(scale 0-10), scores on a scale Standard Deviation 0.9
Post-operative Pain/Discomfort 24 hours	1.1 VAS(scale 0-10), scores on a scale Standard Deviation 0.5	3 VAS(scale 0-10), scores on a scale Standard Deviation 0.8

SECONDARY outcome

Timeframe: Up to 6 months post extraction and ridge preservation

Population: 16 sites were analyzed of 8 participants, 8 OFT sites and 8 CFT sites were analyzed

Histomorphometric analysis of bone core biopsy to determine percent new bone formation

Outcome measures

Outcome measures
Measure	OFT vs CFT n=8 site Open flap technique (OFT) with secondary wound closure (test group) and closed flap technique (CFT) with primary wound closure (control group).	Closed Flap Technique n=8 site Healing by primary intention: Extraction and ridge preservation, utilizing non-resorbable membrane (Cytoplast® TXT-200 ) and freeze dried bone allograft (MinerOss® Cortical and Cancellous Chips (FDBA)), with flaps in primary coverage. Cytoplast® TXT-200: Non-resorbable membrane MinerOss® Cortical and Cancellous Chips (FDBA): Mixture of allograft mineralized cortical and cancellous chips Closed Flap Technique: After extraction, the socket wound is closed by primary closure
Percentage New Bone Formation	34 percentage of new bone formation Standard Deviation 15	39 percentage of new bone formation Standard Deviation 10

Adverse Events

Open Flap Technique (OFT)

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Closed Flap Technique (CFT)

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. Yong Hur

Tufts University

Phone: 6176366531

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place