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NCT Number: NCT06315413

Composite Plug Vs D-PTFE Membrane in Socket Preservation

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.

Recruiting

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Key information

Age range

20 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Faculty of oral and dental medicine, Cairo university

Cairo, Cairo Governorate, 4240310, Egypt

Location status: Recruiting

Location contact

Youssef E Meshreky, Bachelor

CONTACT

[email protected]

01006382121 ext. 002

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Socket preservation using xenograft and composite plug

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.

Socket preservation using xenograft and intentionally exposed d-PTFE

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.

Primary outcomes

  1. Change in horizontal bone dimension

    Time frame: 4 Months

    Cone beam computed tomography (CBCT) (Millimeters)

Secondary outcomes

  1. Change in Vertical bone dimension

    Time frame: 4 Months

    Cone beam computed tomography (CBCT) (Millimeters)

  2. Keratinized tissue thickness

    Time frame: 4 Months

    Millimeters

  3. Procedural time

    Time frame: During surgery

    Stopwatch

  4. Post-operative pain

    Time frame: 1 week

    Visual analogue scale (Santos, Botelho et al. 2021) (0-10) 0=No discomfort 10=Worst discomfort

  5. Patient Satisfaction

    Time frame: 2 weeks

    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)

  6. Incidence of complications

    Time frame: 4 Months

    Checklist

Study contacts

Contact information is provided by the study sponsor or research team.

Youssef Meshreky, Master degree

CONTACT

[email protected]

+201006382121

Sponsors and collaborators

Lead sponsor

Cairo University

Other

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Mar 18, 2024
Registry last updated
Mar 26, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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