NCT03136913

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

Completed NA Results posted Last updated 12 August 2021

What this trial tests

NA trial testing Cytoplast® TXT-200 in Loss of Teeth Due to Extraction in 13 participants. Completed in 11 October 2016.

Timeline

17 February 2015

Primary endpoint
1 April 2016

11 October 2016

Quick facts

Lead sponsor	Tufts University
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	13
Start date	17 February 2015
Primary completion	1 April 2016
Estimated completion	11 October 2016
Sites	1 location across United States

Drugs / interventions tested

• Cytoplast® TXT-200
• MinerOss® Cortical and Cancellous Chips (FDBA)
• Open Flap Technique
• Closed Flap Technique

Conditions studied

• Loss of Teeth Due to Extraction — all drugs for Loss of Teeth Due to Extraction →

Sponsor

Tufts University

Who can join

18 and older, any sex, with Loss of Teeth Due to Extraction. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Mean Difference in Alveolar Bone Height Change Primary · < 6 months post extraction and ridge preservation

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.

OFT

Group	Value	95% CI
OFT vs CFT	7.5	± 1.8

CFT

Group	Value	95% CI
OFT vs CFT	8.1	± 1.9

Post-operative Pain/Discomfort Secondary · Up to 16 days post extraction and ridge preservation

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)

24 hours

Group	Value	95% CI
Open Flap Technique	1.1	± 0.5
Closed Flap Technique	3	± 0.8

2 weeks

Group	Value	95% CI
Open Flap Technique	0.4	± 0.5
Closed Flap Technique	0.8	± 0.9

Percentage New Bone Formation Secondary · Up to 6 months post extraction and ridge preservation

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

Group	Value	95% CI
Open Flap Technique	34	± 15
Closed Flap Technique	39	± 10

Sponsor's own description

This study is being conducted to compare the outcomes of two separate surgical techniques used in tooth extraction and ridge preservation. Ridge preservation is done to potentially minimize the amount of bone loss that occurs between the tooth extraction and implant or bridge placement, as compared to leaving the extraction site empty. There are two techniques that are commonly used for these procedures, either to close the surgical site of the extracted tooth with sutures (closed flap technique) or to leave the extraction site open to heal naturally (open flap technique). In the open flap technique there will be sutures used to secure and hold down the material used to cover the wound, called a non-resorbable membrane. The flaps will remain in their natural position, the site will fill up naturally with new tissue from the bottom up and then close itself in from the sides. The investigators want to see which technique offers better healing and reduces bone loss.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

1. A Comparison between Primary and Secondary Flap Coverage in Ridge Preservation Procedures: A Pilot Randomized Controlled Clinical Trial.
   Aladmawy MA, Natto ZS, Steffensen B, Levi P, et al · · 2019 · cited 11× · PMID 31531367 · DOI 10.1155/2019/7679319
2. Histological and histomorphometric evaluation of alveolar ridge preservation using an allograft and nonresorbable membrane with and without primary closure: A pilot randomized controlled clinical trial.
   Aladmawy MA, Natto ZS, Kreitzer M, Ogata Y, et al · · 2022 · cited 4× · PMID 35777057 · DOI 10.1097/md.0000000000029769