Periosteal Inhibition Technique for Ridge Preservation A Prospective Study (PI)

December 3, 2018 updated by: Vinh Giap Nguyen, DDS, Clinique Dentaire et d'implantologie Dr.Vinh Nguyen
The efficacy of the Periosteal Inhibition technique for socket preservation is studies against a control group in which the extraction sockets are allowed to heal without a socket preservation procedure.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

Socket preservation procedures have been shown to significantly reduce the loss of ridge dimension of an extraction socket. These procedures involve filling the empty socket with a bone graft material, which, serves as scaffold to limit horizontal and vertical ridge alterations. In order to contain the graft material, an occlusive barrier such as an autogenous soft tissue graft, resorbable or non-resorbable membrane, is often required. As yet, no one socket preservation technique has been proven superior to another, and none have proven totally effective in preserving ridge morphology. A net reduction of 1.5 mm in ridge width and 0.5 mm in ridge height is often observed after socket preservation procedures, which may necessitate additional hard or soft tissue augmentation to fully restore the ridge dimension.

In an animal histologic study in 2005, Araujo and Lindhe demonstrated that trauma and loss of periodontal ligament triggered an osteoclastic activity causing loss of bundle bone and modeling of the cortical bone plate. Osteoclasts are multi-nucleated cells that are responsible for bone resorption and are found on the outer layer of bone, beneath the periosteum. Osteoclasts are thought to be derived from pluripotent hematopoietic stem cells. When stimulated, these mononuclear precursors, the smallest of which is 9.5 microns in diameter, proliferate and attach to the bone surface to be resorbed, and only then fuse to form large mature multinucleated osteoclasts.

High-density polytetrafluoroethylene (d-ptfe) membranes have been used in socket preservation procedures as an occlusive barrier to contain the bone graft material.Polytetrafluoroethylene, a stable polymer and highly biocompatible, has a membrane porosity of less than 0.3 microns. It is impervious to bacteria and thus is recommended for a socket preservation technique, where a membrane is intentionally exposed.

In the present study, a high-density polytetrafluoroethylene (d-ptfe) membrane is placed between the periosteum and the buccal bone plate of an extraction socket where it will stay for a duration of 4 months, the time needed for the completion of bone forming within the socket. The goal of the non-resorbable d-ptfe membrane is to prevent the migration of precursor cells to the bone surface and thus their fusion to form osteoclast. The authors hypothesize that the passage of the precursor cells from the periosteum to the bone surface is inhibited by the small-diameter pores in the non-resorbable d-ptfe membrane. Osteolytic activity on the outer surface of the socket is thereby prevented as the precursor cells cannot form osteoclasts. The author coins the term "Periosteal Inhibition technique" for this socket preservation procedure.The study will compare dimension changes between extraction socket treated using the Periosteal Inhibition technique and those allowed to heal without a socket preservation procedure.

Study Type

Interventional

Enrollment (Anticipated)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

22 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • At least 22 years of age
  • Systemically healthy
  • An extraction of one non-salvageable molar or premolar tooth is indicated. Adjacent teeth must be present to support the measuring template.
  • Demonstrated ability to maintain goodoral hygiene
  • Willingness and ability to commit to follow-up
  • Able to understand study procedure and provide signed informed consent.

Exclusion Criteria:

  • Extensive damaged buccal or lingual bone plate
  • Extreme alveolar ridge atrophy
  • Extensive vertical bone loss
  • Active infection at the extraction site
  • Uncontrolled periodontal disease.
  • Recent febrile illness (within 6 months) that precludes or delays participation
  • Severe renal or liver diseases
  • History of radiotherapy of the head and neck region
  • Chemotherapy for treatment of malignant tumors at the time of the study.
  • Immuno-compromised patients
  • Patients on IV bisphosphonates or on long term oral bisphosphonates for more than 3 years.
  • Use of disallowed concomitant medications.
  • Pregnancy or intending to conceive during the course of the Study.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Test group
A d-ptfe membrane will be placed between the buccal bone and periosteum of an extraction socket during a 4 months healing time before it is surgically removed.
Device: d-ptfe membrane
Socket preservation using d-ptfe membrane to inhibit the formation of osteoclasts
No Intervention: Control group
The extraction socket will be left to heal naturally without a socket preservation intervention.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Ridge widths
Time Frame: 0 hour and 4 months
Bucco-lingual ridge dimensions at the midline is measured at 3mm and 5mm apical to the gingival margin, at the time of extraction intra-op and 4 months post-extraction, using a acrylic template for repeatable measurements.
0 hour and 4 months
Change in Ridge widths on the buccal and lingual aspects
Time Frame: 0 hour and 4 months
Buccal and lingual ridge dimension change at the midline is measured at 3mm and 5mm apical to the gingival margin, at the time of extraction and 4 months post-extraction, using a acrylic template for repeatable measurements.
0 hour and 4 months
Change in Ridge heights
Time Frame: 0 hour and 4 months
Change in Ridge bone heights at messiah and distal interproximal, mid-buccal and mid-lingual aspects.
0 hour and 4 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Bone plate thickness
Time Frame: 0 hour
Marginal buccal and lingual bone plate thickness
0 hour
Keratinized mucosa
Time Frame: 0 hour and 4 months
Width of keratinized mucosa over the ridge
0 hour and 4 months

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Complications
Time Frame: 1 month, 2 months, 3 months and 4 months
To assess complication rate of the procedure.
1 month, 2 months, 3 months and 4 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Clinique Dentaire et d'implantologie Dr.Vinh Nguyen

Collaborators

Goethe University

Investigators

  • Principal Investigator: Vinh Giap Nguyen, DDS, MSc

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

December 15, 2018

Primary Completion (Anticipated)

December 31, 2020

Study Completion (Anticipated)

December 31, 2020

Study Registration Dates

First Submitted

December 1, 2018

First Submitted That Met QC Criteria

December 3, 2018

First Posted (Actual)

December 4, 2018

Study Record Updates

Last Update Posted (Actual)

December 4, 2018

Last Update Submitted That Met QC Criteria

December 3, 2018

Last Verified

December 1, 2018

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • PI2018

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Yes

IPD Plan Description

De-identified individual participant data for all primary and secondary outcome measures will made available.

IPD Sharing Time Frame

Data will be available within 6 months of study completion.

IPD Sharing Access Criteria

Data access requests will be reviewed by an external Independent Review Panel. Requestors will be required to sign a Data Access Agreement.

IPD Sharing Supporting Information Type

  • Study Protocol
  • Statistical Analysis Plan (SAP)
  • Clinical Study Report (CSR)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Ridge Deficency

Clinical Trials on d-ptfe membrane

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Malaysia

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe