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

Primary Purpose

Loss of Teeth Due to Extraction

Status

Completed

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Cytoplast® TXT-200

MinerOss® Cortical and Cancellous Chips (FDBA)

Open Flap Technique

Closed Flap Technique

About this trial

This is an interventional treatment trial for Loss of Teeth Due to Extraction

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

Patient who is treatment planned at Tufts University School of Dental Medicine (TUSDM) for extraction and future implant placement and meet all medical and dental requirements of the TUSDM periodontology clinic for periodontal surgery (e.g., subjects with no diseases or medication allergies contraindicating periodontal surgery).
- Patient must have bilateral extraction (canine to molar) sites of teeth located on the same arch (e.g. upper right and upper left) treatment planned for future implant placement at TUSDM.
- The number of teeth planned for extraction (either one or two adjacent) and ridge preservation should match the same number of teeth (either one or two adjacent) from the contra-lateral side on the same arch.
- Presence of at least 3 intact bony walls and at least half of the fourth bony wall at each site as determined by bone sounding at Visit 1.

Exclusion Criteria:

Have any known disease that interferes with periodontal surgery and would not allow the patient to be treatment planned for the procedures in the TUSDM periodontology clinic (e.g., severe anemia, low white blood cell count, bleeding or coagulation disorder, uncontrolled hypertension (150/90), recent myocardial infarction (within 6 months of enrollment), diabetes (HbA1C ≥7%), HIV/AIDS (self-reported), history of or currently undergoing head and neck radiation, history of or currently taking bisphosphonates).
- Subject who has a disease or condition that may affect hard and soft tissue healing (e.g., previous or current head and neck radiation therapy, long term steroid use defined as more than two weeks in the past two years).
- Subject who has diseases that affect bone metabolism (e.g., osteoporosis, osteopenia).
- Pregnancy (self-reported)
- Current Smokers
- Extraction socket with > 50% bone loss on the buccal or lingual/palatal bone as determined by bone sounding at Visit 1.
- Allergic to gentamycin, povidone-iodine, or surfactants as trace amounts may be contained in the MinerOss®

Sites / Locations

Tufts University School of Dental Medicine

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Arm Label

Closed Flap Technique

Open Flap Technique

Arm Description

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.

Healing by secondary 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 position for healing by secondary intention.

Outcomes

Primary Outcome Measures

Mean Difference in Alveolar Bone Height Change

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.

Secondary Outcome Measures

Post-operative Pain/Discomfort

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)

Percentage New Bone Formation

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

Full Information

NCT ID

NCT03136913

First Posted

April 27, 2017

Last Updated

July 20, 2021

Sponsor

Tufts University

1. Study Identification

Unique Protocol Identification Number

NCT03136913

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

July 2021

Overall Recruitment Status

Completed

Study Start Date

February 17, 2015 (Actual)

Primary Completion Date

April 1, 2016 (Actual)

Study Completion Date

October 11, 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Tufts University

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Yes

Product Manufactured in and Exported from the U.S.

Yes

Data Monitoring Committee

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Loss of Teeth Due to Extraction

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

13 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Closed Flap Technique

Arm Type

Active Comparator

Arm Description

Arm Title

Open Flap Technique

Arm Type

Active Comparator

Arm Description

Intervention Type

Device

Intervention Name(s)

Cytoplast® TXT-200

Intervention Description

Non-resorbable membrane

Intervention Type

Device

Intervention Name(s)

MinerOss® Cortical and Cancellous Chips (FDBA)

Intervention Description

Mixture of allograft mineralized cortical and cancellous chips

Intervention Type

Procedure

Intervention Name(s)

Open Flap Technique

Intervention Description

After extraction, the socket wound is left open to heal by secondary intention

Intervention Type

Procedure

Intervention Name(s)

Closed Flap Technique

Intervention Description

After extraction, the socket wound is closed by primary closure

Primary Outcome Measure Information:

Title

Mean Difference in Alveolar Bone Height Change

Description

Time Frame

< 6 months post extraction and ridge preservation

Secondary Outcome Measure Information:

Title

Post-operative Pain/Discomfort

Description

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)

Time Frame

Up to 16 days post extraction and ridge preservation

Title

Percentage New Bone Formation

Description

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

Time Frame

Up to 6 months post extraction and ridge preservation

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Patient who is treatment planned at Tufts University School of Dental Medicine (TUSDM) for extraction and future implant placement and meet all medical and dental requirements of the TUSDM periodontology clinic for periodontal surgery (e.g., subjects with no diseases or medication allergies contraindicating periodontal surgery). Patient must have bilateral extraction (canine to molar) sites of teeth located on the same arch (e.g. upper right and upper left) treatment planned for future implant placement at TUSDM. The number of teeth planned for extraction (either one or two adjacent) and ridge preservation should match the same number of teeth (either one or two adjacent) from the contra-lateral side on the same arch. Presence of at least 3 intact bony walls and at least half of the fourth bony wall at each site as determined by bone sounding at Visit 1. Exclusion Criteria: Have any known disease that interferes with periodontal surgery and would not allow the patient to be treatment planned for the procedures in the TUSDM periodontology clinic (e.g., severe anemia, low white blood cell count, bleeding or coagulation disorder, uncontrolled hypertension (150/90), recent myocardial infarction (within 6 months of enrollment), diabetes (HbA1C ≥7%), HIV/AIDS (self-reported), history of or currently undergoing head and neck radiation, history of or currently taking bisphosphonates). Subject who has a disease or condition that may affect hard and soft tissue healing (e.g., previous or current head and neck radiation therapy, long term steroid use defined as more than two weeks in the past two years). Subject who has diseases that affect bone metabolism (e.g., osteoporosis, osteopenia). Pregnancy (self-reported) Current Smokers Extraction socket with > 50% bone loss on the buccal or lingual/palatal bone as determined by bone sounding at Visit 1. Allergic to gentamycin, povidone-iodine, or surfactants as trace amounts may be contained in the MinerOss®

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Yong Hur, DMD, MSc

Organizational Affiliation

TUSDM

Official's Role

Principal Investigator

Facility Information:

Facility Name

Tufts University School of Dental Medicine

City

Boston

State/Province

Massachusetts

ZIP/Postal Code

02111

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

Citations:

PubMed Identifier

35777057

Citation

Aladmawy MA, Natto ZS, Kreitzer M, Ogata Y, Hur Y. 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. Medicine (Baltimore). 2022 Jul 1;101(26):e29769. doi: 10.1097/MD.0000000000029769.

Results Reference

derived

PubMed Identifier

31531367

Citation

Aladmawy MA, Natto ZS, Steffensen B, Levi P, Cheung W, Finkelman M, Ogata Y, Hur Y. A Comparison between Primary and Secondary Flap Coverage in Ridge Preservation Procedures: A Pilot Randomized Controlled Clinical Trial. Biomed Res Int. 2019 Aug 20;2019:7679319. doi: 10.1155/2019/7679319. eCollection 2019.

Results Reference

derived

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

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