Composite Plug Vs D-PTFE Membrane in Socket Preservation

Evaluation of Socket Seal Using Flowable Composite Above Xenograft Compared to Dense Polytetrafluoroethylene (d-PTFE) Membrane in Ridge Preservation Procedures: a Randomized Controlled Clinical Trial

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.

Study Overview

• Status: Recruiting
• Conditions: Alveolar Bone Loss
• Intervention / Treatment: Procedure: Socket preservation using xenograft and composite plug; Procedure: Socket preservation using xenograft and intentionally exposed d-PTFE

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.

• Study Type: Interventional
• Enrollment (Estimated): 20
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Youssef Meshreky, Master degree; Phone Number: +201006382121; Email: youssefmeshreky@gmail.com

Study Locations

• Egypt
  • Cairo, Egypt, 4240310
    • Recruiting
    • faculty of oral and dental medicine, Cairo university
    • Contact: Youssef E Meshreky, Bachelor; Phone Number: 002 01006382121; Email: youssefmeshreky@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Procedure: 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.
Active Comparator: 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.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in horizontal bone dimension	Cone beam computed tomography (CBCT) (Millimeters)	4 Months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Vertical bone dimension	Cone beam computed tomography (CBCT) (Millimeters)	4 Months
Keratinized tissue thickness	Millimeters	4 Months
Procedural time	Stopwatch	During surgery
Post-operative pain	Visual analogue scale (Santos, Botelho et al. 2021) (0-10) 0=No discomfort 10=Worst discomfort	1 week
Patient Satisfaction	Three questions questionnaire (Kiyak, Hohl et al. 1984). 7-point response scale: 7= very likely (or very satisfied), 1= not at all likely (or not at all satisfied)	2 weeks
Incidence of complications	Checklist	4 Months

Collaborators and Investigators

• Sponsor: Cairo University

Study record dates

Study Major Dates

• Study Start (Estimated): May 1, 2025
• Primary Completion (Estimated): September 1, 2025
• Study Completion (Estimated): October 1, 2025

Study Registration Dates

• First Submitted: March 10, 2024
• First Submitted That Met QC Criteria: March 14, 2024
• First Posted (Actual): March 18, 2024

Study Record Updates

• Last Update Posted (Estimated): March 26, 2025
• Last Update Submitted That Met QC Criteria: March 22, 2025
• Last Verified: August 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Bone Resorption; Bone Diseases; Musculoskeletal Diseases; Periodontal Atrophy; Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases; Alveolar Bone Loss
• Other Study ID Numbers: Composite plug vs d-PTFE

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No