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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

Status
Recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06315413
Enrollment
20
Registered
2024-03-18
Start date
2025-05-31
Completion date
2025-10-31
Last updated
2025-03-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Alveolar Bone Loss

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.

Interventions

PROCEDURESocket 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.

PROCEDURESocket 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.

Sponsors

Cairo University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
20 Years to 70 Years
Healthy volunteers
Yes

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.

Design outcomes

Primary

MeasureTime frameDescription
Change in horizontal bone dimension4 MonthsCone beam computed tomography (CBCT) (Millimeters)

Secondary

MeasureTime frameDescription
Keratinized tissue thickness4 MonthsMillimeters
Procedural timeDuring surgeryStopwatch
Change in Vertical bone dimension4 MonthsCone beam computed tomography (CBCT) (Millimeters)
Patient Satisfaction2 weeksThree 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)
Incidence of complications4 MonthsChecklist
Post-operative pain1 weekVisual analogue scale (Santos, Botelho et al. 2021) (0-10) 0=No discomfort 10=Worst discomfort

Countries

Egypt

Contacts

Primary ContactYoussef Meshreky, Master degree
youssefmeshreky@gmail.com+201006382121

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026