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

NCT03136913 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 13

Last updated 2021-08-12

Study results available
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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.

Conditions

  • Loss of Teeth Due to Extraction

Interventions

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

Sponsors & Collaborators

  • Tufts University

    lead OTHER

Principal Investigators

  • Yong Hur, DMD, MSc · TUSDM

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2015-02-17
Primary Completion
2016-04-01
Completion
2016-10-11
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03136913 on ClinicalTrials.gov