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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06315413
Other study ID # Composite plug vs d-PTFE
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date June 1, 2024
Est. completion date December 1, 2025

Study information

Verified date May 2024
Source Cairo University
Contact Youssef Meshreky, Master degree
Phone +201006382121
Email youssefmeshreky@gmail.com
Is FDA regulated No
Health authority
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 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.

Study Design


Related Conditions & MeSH terms


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
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