Composite Plug vs d-PTFE Membrane in Socket Preservation
- Conditions
- Alveolar Bone Loss
- Interventions
- Procedure: Socket preservation using xenograft and composite plugProcedure: Socket preservation using xenograft and intentionally exposed d-PTFE
- Registration Number
- NCT06315413
- Lead Sponsor
- Cairo University
- 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 20
- 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).
- 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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Composite plug Socket preservation using xenograft and 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. Exposed d-PTFE Socket preservation using xenograft and intentionally 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.
- Primary Outcome Measures
Name Time Method Change in horizontal bone dimension 4 Months Cone beam computed tomography (CBCT) (Millimeters)
- Secondary Outcome Measures
Name Time Method Change in Vertical bone dimension 4 Months Cone beam computed tomography (CBCT) (Millimeters)
Incidence of complications 4 Months Checklist
Post-operative pain 1 week Visual analogue scale (Santos, Botelho et al. 2021) (0-10) 0=No discomfort 10=Worst discomfort
Patient Satisfaction 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)Keratinized tissue thickness 4 Months Millimeters
Procedural time During surgery Stopwatch
Trial Locations
- Locations (1)
Faculty of oral and dental medicine, Cairo university
🇪🇬Cairo, Egypt