Clinical trial NCT06315413: Composite Plug Vs D-PTFE Membrane in Socket Preservation
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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Alveolar Bone Loss
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2024-03-18
Enrollment: 20
Sex: ALL
Minimum age (years): 20
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Change in horizontal bone dimension
timeFrame: 4 Months
Secondary outcomes:
measure: Change in Vertical bone dimension
timeFrame: 4 Months
measure: Keratinized tissue thickness
timeFrame: 4 Months
measure: Procedural time
timeFrame: During surgery
measure: Post-operative pain
timeFrame: 1 week
measure: Patient Satisfaction
timeFrame: 2 weeks
measure: Incidence of complications
timeFrame: 4 Months
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Faculty of oral and dental medicine, Cairo university
Study officials:
References: