NCT03136913

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 13 (actual)
• Sponsor: Tufts University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

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.

Detailed description

Study design will be a single center, randomized controlled trial, split mouth designed study, to compare the bone dimensional changes following extraction and ridge preservation in surgical techniques that leave the flap open and closed. The primary aim of this study is to evaluate the bone dimensional changes following extraction and ridge preservation with primary coverage (closed flap technique) in comparison to secondary intention (open flap technique). The investigators hypothesize that the closed flap technique will have more potential to maintain vertical bone height when compared with the open flap technique, due to less susceptibility from infection and inflammation. Secondary aim is to evaluate patients' self-report of postoperative discomfort. The investigators hypothesize that open flap technique will have less post-operative pain/discomfort due to less flap dissection and elevation when compared to closed flaps. Tertiary aim is to have a histomorphometric examination and to assess the formation of new bone. The investigators hypothesize that better bone volume percentage will be observed in closed flap technique when compared to open flap technique. The primary outcome is the mean difference in alveolar bone height change between groups.

Conditions

• Loss of Teeth Due to Extraction

Interventions

Type	Name	Description
DEVICE	Cytoplast® TXT-200	Non-resorbable membrane
DEVICE	MinerOss® Cortical and Cancellous Chips (FDBA)	Mixture of allograft mineralized cortical and cancellous chips
PROCEDURE	Open Flap Technique	After extraction, the socket wound is left open to heal by secondary intention
PROCEDURE	Closed Flap Technique	After extraction, the socket wound is closed by primary closure

Timeline

• Start date: 2015-02-17
• Primary completion: 2016-04-01
• Completion: 2016-10-11
• First posted: 2017-05-02
• Last updated: 2021-08-12
• Results posted: 2021-08-12

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study