Actively Recruiting

Phase Not Applicable
Age: 20Years - 70Years
All Genders
Healthy Volunteers
ID06315413

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

Led by Cairo University · Updated on 2025-03-26

20

Participants Needed

1

Research Sites

4 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

Researchers are evaluating the effects of two different methods for sealing tooth extraction sites in patients with alveolar bone loss. The study compares using a flowable resin composite plug versus a dense polytetrafluoroethylene (d-PTFE) membrane after filling the extraction socket with xenograft particles. The goal is to see how these methods impact soft and hard tissue changes, procedural time, post-operative pain, patient satisfaction, and cost effectiveness in preserving bone for future dental implants. The study involves two groups: one receives a tooth extraction followed by socket cleaning, xenograft filling, and coverage with an injected flowable composite plug stabilized with sutures. The other group undergoes the same extraction and grafting process but uses an intentionally exposed d-PTFE membrane secured with sutures instead of the composite plug. Both treatments aim to preserve bone dimensions after extraction. Participants will be followed for four months to monitor changes in horizontal and vertical bone dimensions, keratinized tissue thickness, procedural time during surgery, post-operative pain over one week, patient satisfaction after two weeks, and any complications. These assessments include clinical evaluations and patient questionnaires. The total duration of involvement includes the initial treatment and the four-month follow-up period.

CONDITIONS

Brief Title

Composite Plug Vs D-PTFE Membrane in Socket Preservation

Who Can Participate

Age: 20Years - 70Years
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • 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).
Not Eligible

You will not qualify if you...

  • 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 (60 10 cigarettes per day).
  • Pregnant or lactating females.
  • Alcoholism or drug abuse.
  • Psychiatric problems.

AI-Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Treatment

Duration - Day of surgery

Participants undergo tooth extraction followed by socket preservation using either a composite plug or a d-PTFE membrane to help maintain bone dimensions after extraction.

1 surgical visit (in-person)

Post-operative Follow-up

Duration - 4 months

Participants are monitored for healing, post-operative pain, patient satisfaction, and any complications following the socket preservation procedure.

Multiple visits including assessments at 1 week, 2 weeks, and 4 months (in-person)

Trial Site Locations

Total: 1 location

1

Faculty of oral and dental medicine, Cairo university

Cairo, Cairo Governorate, Egypt, 4240310

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Research Team

Y

Youssef Meshreky, Master degree

How is the study designed?

Study Type

INTERVENTIONAL

Masking

DOUBLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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