Composite Plug Vs D-PTFE Membrane in Socket Preservation

NCT ID: NCT06315413

Last Updated: 2025-03-26

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-05-31
• Study Completion Date: 2025-10-31

Brief Summary

The aim of the current study is to compare the effect socket sealing with flowable resin composite compared to dense polytetrafluoroethylene membrane after filling the extraction site with xenograft particles in terms of soft and hard tissue changes, procedural time, post operative pain, patients' satisfaction, and cost effectiveness.

Detailed Description

Implant placement has become the gold standard for replacing missing teeth. One of the biggest challenges present when placing implants is the lack of sufficient bone dimensions. This deficiency may be a common finding due to the process of post extraction remodeling where both bone height and width are reduced, complicating implant placement. As a result, several procedures have been suggested to address this issue. Socket preservation is one of the most implemented procedures used today to limit the amount of bone lost during post extraction remodeling. The current study was designed to compare the effectiveness of using flowable composite resin for socket sealing as an alternative to using d-PTFE membranes, bypassing the added time, cost and trauma needed for tunnel preparation and membrane tucking.

Conditions

Alveolar Bone Loss

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Composite plug

Tooth extraction will be done a-traumatically followed by socket curettage and cleaning followed by xenograft filling for the socket and coverage with injected flowable composite plug which will then be stabilized using 5.0 polypropylene suture material with a figure of eight suture.

Group Type: EXPERIMENTAL

Socket preservation using xenograft and composite plug

Intervention Type: PROCEDURE

Extraction of hopeless teeth will be followed by grafting the socket with xenograft and coverage with injected flowable composite plug which will then be stabilized using 5.0 polypropylene suture material with a figure of eight suture.

Exposed d-PTFE

Tooth extraction will be done a-traumatically followed by socket curettage and cleaning followed by xenograft filling for the socket and coverage with d-PTFE membrane which will be left exposed intentionally and secured using 5.0 polypropylene suture material with a figure of eight suture.

Group Type: ACTIVE_COMPARATOR

Socket preservation using xenograft and intentionally exposed d-PTFE

Intervention Type: PROCEDURE

Extraction of hopeless teeth will be followed by grafting the socket with xenograft and coverage with d-PTFE membrane which will the be left exposed intentionally. This will be followed by securing the membrane using 5.0 polypropylene suture material with a figure of eight suture.

Interventions

Socket preservation using xenograft and composite plug

Extraction of hopeless teeth will be followed by grafting the socket with xenograft and coverage with injected flowable composite plug which will then be stabilized using 5.0 polypropylene suture material with a figure of eight suture.

Intervention Type: PROCEDURE

Socket preservation using xenograft and intentionally exposed d-PTFE

Extraction of hopeless teeth will be followed by grafting the socket with xenograft and coverage with d-PTFE membrane which will the be left exposed intentionally. This will be followed by securing the membrane using 5.0 polypropylene suture material with a figure of eight suture.

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

• Patients having single non-adjacent hopeless maxillary tooth in the esthetic zone that are indicated for extraction.
• Patients with healthy systemic condition.
• Patients aged from 20 to 70 years old.
• Good oral hygiene.
• Accepts 4 months follow-up period (cooperative patients).

Exclusion Criteria

• Systemic diseases or medications that might affect bone metabolism, increase surgical risk or complicate post-operative healing.
• Previous bone augmentation to implant site.
• Untreated periodontal diseases.
• Para-functional habits such as bruxism and clenching.
• History of radiation therapy to the head and neck.
• Heavy smokers (≥ 10 cigarettes per day).
• Pregnant or lactating females.
• Alcoholism or drug abuse.
• Psychiatric problems.

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Cairo University

OTHER

Sponsor Role: lead

Responsible Party

Youssef Emad Zaghloul Meshreky

Assistant lecturer of Periodontology, Newgiza University

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Faculty of oral and dental medicine, Cairo university

Cairo, Cairo Governorate, Egypt

Site Status: RECRUITING

Countries

Egypt

Central Contacts

Youssef Meshreky, Master degree

Role: CONTACT

youssefmeshreky@gmail.com

+201006382121

Facility Contacts

Youssef E Meshreky, Bachelor

Role: primary

youssefmeshreky@gmail.com

01006382121 ext. 002

Other Identifiers

Composite plug vs d-PTFE

Identifier Type: -

Identifier Source: org_study_id