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Composite Plug vs d-PTFE Membrane in Socket Preservation

Not Applicable
Recruiting
Conditions
Alveolar Bone Loss
Interventions
Procedure: Socket preservation using xenograft and composite plug
Procedure: 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
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).
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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.
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Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
Composite plugSocket preservation using xenograft and composite plugTooth 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-PTFESocket preservation using xenograft and intentionally exposed d-PTFETooth 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
NameTimeMethod
Change in horizontal bone dimension4 Months

Cone beam computed tomography (CBCT) (Millimeters)

Secondary Outcome Measures
NameTimeMethod
Change in Vertical bone dimension4 Months

Cone beam computed tomography (CBCT) (Millimeters)

Incidence of complications4 Months

Checklist

Post-operative pain1 week

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

Patient Satisfaction2 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 thickness4 Months

Millimeters

Procedural timeDuring surgery

Stopwatch

Trial Locations

Locations (1)

Faculty of oral and dental medicine, Cairo university

🇪🇬

Cairo, Egypt

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