Composite Plug vs d-PTFE Membrane in Socket Preservation

Alveolar Bone Loss Clinical Trial

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06315413
• Other study ID #: Composite plug vs d-PTFE
• Status: Not yet recruiting
• Phase: N/A
• Start date: April 1, 2024
• Est. completion date: December 1, 2025

Study information

• Verified date: March 2024
• Source: Cairo University
• Contact: Youssef Meshreky, Master degree
• Phone: +201006382121
• Email: youssefmeshreky[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Not yet recruiting
• Enrollment: 20
• Est. completion date: December 1, 2025
• Est. primary completion date: August 1, 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 20 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• Alveolar Bone Loss

Intervention

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.
• 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.

Locations

Country	Name	City	State
Egypt	Faculty of oral and dental medicine, Cairo university	Cairo

Sponsors (1)

Lead Sponsor	Collaborator
Cairo University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in horizontal bone dimension	Cone beam computed tomography (CBCT) (Millimeters)	4 Months
Secondary	Change in Vertical bone dimension	Cone beam computed tomography (CBCT) (Millimeters)	4 Months
Secondary	Keratinized tissue thickness	Millimeters	4 Months
Secondary	Procedural time	Stopwatch	During surgery
Secondary	Post-operative pain	Visual analogue scale (Santos, Botelho et al. 2021) (0-10) 0=No discomfort 10=Worst discomfort	1 week
Secondary	Patient Satisfaction	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)	2 weeks
Secondary	Incidence of complications	Checklist	4 Months