Loss of Teeth Due to ExtractionNCT03136913

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

A study testing Cytoplast® TXT-200, MinerOss® Cortical and Cancellous Chips (FDBA) and Open Flap Technique in people with Loss of Teeth Due to Extraction, run by Tufts University at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for: Loss of Teeth Due to Extraction
What is being tested?: Cytoplast® TXT-200, MinerOss® Cortical and Cancellous Chips (FDBA) and Open Flap Technique
Type of treatment: Medical device, Surgery or procedure
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 13 participants
Where: 1 siteUnited States
Study dates: 17 Feb 2015to 11 Oct 2016
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

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.

Who cannot join

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®

Trial locations and contacts

1 site in 1 country.

United States1 site

Tufts University School of Dental Medicine
Boston, Massachusetts, 02111

Other trials in United States

About this study

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.

Read the 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
Being tested: Cytoplast® TXT-200, MinerOss® Cortical and Cancellous Chips (FDBA), Open Flap Technique, Closed Flap Technique

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

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

Study groups in NCT03136913
Study group	Role	What they receive
Closed Flap Technique	Active comparator	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. Receives: Device: Cytoplast® TXT-200; Device: MinerOss® Cortical and Cancellous Chips (FDBA); Procedure: Closed Flap Technique
Open Flap Technique	Active comparator	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. Receives: Device: Cytoplast® TXT-200; Device: MinerOss® Cortical and Cancellous Chips (FDBA); Procedure: Open Flap Technique

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: < 6 months post extraction and ridge preservation

Secondary outcomes (2)

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)
Measured: Up to 16 days post extraction and ridge preservation
Percentage New Bone Formation
Histomorphometric analysis of bone core biopsy to determine percent new bone formation
Measured: Up to 6 months post extraction and ridge preservation

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

17 Feb 201511 Oct 2016

First posted2 May 2017
Study start17 Feb 2015
Primary completion1 Apr 2016
Study completion11 Oct 2016

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (2)Papers the sponsor has linked to this study.
Other trials for Loss of Teeth Due to ExtractionStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 13 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03136913
Sponsor's protocol ID: 11441
Status last verified: Jul 2021
First submitted: 27 Apr 2017
Last updated: 12 Aug 2021
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: Yes
Individual data sharing: No

Publications

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.
PubMed 35777057
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.
PubMed 31531367

Study at a glance

From the registry record, last updated by the sponsor on 12 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Comparison Between Primary and Secondary Flap Coverage in Extraction Sites: A Pilot Study
ClinicalTrials.gov ID: NCT03136913
Acronym / sponsor ID: 11441
Conditions: Loss of Teeth Due to Extraction
Study type: Interventional
Recruitment status: Completed
Enrolment: 13 participants (actual)
Lead sponsor: Tufts UniversityUniversity, hospital or other
Study start: 17 Feb 2015 (actual)
Primary completion: 1 Apr 2016 (actual)
Study completion: 11 Oct 2016 (actual)
First posted: 2 May 2017 (actual)
Results: Posted 12 Aug 2021

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

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.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Closed Flap Technique	Active comparator	Device: Cytoplast® TXT-200, Device: MinerOss® Cortical and Cancellous Chips (FDBA), Procedure: Closed Flap TechniqueHealing 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.
Open Flap Technique	Active comparator	Device: Cytoplast® TXT-200, Device: MinerOss® Cortical and Cancellous Chips (FDBA), Procedure: Open Flap TechniqueHealing 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.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (4 listed)

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).

Key exclusion criteria (7 listed)

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).

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Cytoplast® TXT-200Non-resorbable membrane	Device	Closed Flap Technique, Open Flap Technique
MinerOss® Cortical and Cancellous Chips (FDBA)Mixture of allograft mineralized cortical and cancellous chips	Device	Closed Flap Technique, Open Flap Technique
Open Flap TechniqueAfter extraction, the socket wound is left open to heal by secondary intention	Procedure or surgery	Open Flap Technique
Closed Flap TechniqueAfter extraction, the socket wound is closed by primary closure	Procedure or surgery	Closed Flap Technique

Primary outcome

Mean Difference in Alveolar Bone Height Change
Time frame: < 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.

2 secondary outcomes

Post-operative Pain/Discomfort
Time frame: Up to 16 days post extraction and ridge preservation
Percentage New Bone Formation
Time frame: Up to 6 months post extraction and ridge preservation

Results and safety

Results posted to the registry on 12 Aug 2021, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
All Study Participants (OFT vs CFT)	13	8

Primary outcome: Mean Difference in Alveolar Bone Height Change

Time frame: < 6 months post extraction and ridge preservation. Mean (Standard Deviation). Unit: mm

Measure	OFT vs CFT n = 10
OFT	7.5 (1.8)
CFT	8.1 (1.9)

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

2 secondary outcomes are reported in the full results.

Adverse events

Time frame: None to report during the study period, 1 year.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Open Flap Technique (OFT)	0 of 10 (0%)	0 of 10 (0%)	0 of 10
Closed Flap Technique (CFT)	0 of 10 (0%)	0 of 10 (0%)	0 of 10

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 12 Aug 2021.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 35777057Aladmawy 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.
Derived from this study: PubMed 31531367Aladmawy 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.
Individual participant dataSharing planned: No

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Yong Hur, DMD, MSc principal investigator

TUSDM

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 12 Aug 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 12 Aug 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Mean Difference in Alveolar Bone Height Change (time frame: < 6 months post extraction and ridge preservation). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03136913, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Aug 2021.