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Recruiting NCT06315413

Composite Plug Vs D-PTFE Membrane in Socket Preservation

No phase Interventional Alveolar Bone Loss

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Socket preservation using xenograft and composite plug, Socket preservation using xenograft and intentionally exposed d-PTFE.
Who it may be relevant to
Registry conditions: Alveolar Bone Loss. Basic parameters: 20 years — 70 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Egypt
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official 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

Overview

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.

Interventions

  • 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.
  • 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.

Primary outcome measures

  • Change in horizontal bone dimension [Time frame: 4 Months]
Secondary outcome measures (6)
  • Change in Vertical bone dimension [Time frame: 4 Months]
  • Keratinized tissue thickness [Time frame: 4 Months]
  • Procedural time [Time frame: During surgery]
  • Post-operative pain [Time frame: 1 week]
  • Patient Satisfaction [Time frame: 2 weeks]
  • Incidence of complications [Time frame: 4 Months]

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Double blind
Primary purpose
Treatment

Study locations

Egypt · 1 center
  • Faculty of oral and dental medicine, Cairo university — Cairo

Identifiers

NCT: NCT06315413 · Composite plug vs d-PTFE

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗