Alveolar Bone LossNCT06315413
Composite Plug Vs D-PTFE Membrane in Socket Preservation
A study testing Socket preservation using xenograft and composite plug and Socket preservation using xenograft and intentionally exposed d-PTFE in people with Alveolar Bone Loss, run by Cairo University at 1 site in Egypt.
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… Read more about this study
- Who is it for?
- Ages 20 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Alveolar Bone Loss
- What is being tested?
- Socket preservation using xenograft and composite plug and Socket preservation using xenograft and intentionally exposed d-PTFE
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteEgypt
- Study dates
- May 2025to Oct 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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).
Who cannot join
- 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).
Show all 9Show fewer
- Pregnant or lactating females.
- Alcoholism or drug abuse.
- Psychiatric problems.
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Faculty of oral and dental medicine, Cairo university
Cairo, Cairo Governorate, 4240310
Youssef E Meshreky, Bachelor, 01006382121 ext. 002, youssefmeshreky@gmail.com
About this study
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
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.
Read the 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.
- Conditions
- Alveolar Bone Loss
- Being tested
- Socket preservation using xenograft and composite plug, Socket preservation using xenograft and intentionally exposed d-PTFE
- Medical subject headings
- Alveolar Bone Loss
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Socket preservation using xenograft and composite plugProcedure or surgery
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-PTFEProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| Composite plug | Experimental | 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. Receives: Procedure: Socket preservation using xenograft and composite plug |
| Exposed d-PTFE | Active comparator | 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. Receives: Procedure: Socket preservation using xenograft and intentionally exposed d-PTFE |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in horizontal bone dimension
Cone beam computed tomography (CBCT) (Millimeters)
Measured: 4 Months
Secondary outcomes (6)
Change in Vertical bone dimension
Cone beam computed tomography (CBCT) (Millimeters)
Measured: 4 Months
Keratinized tissue thickness
Millimeters
Measured: 4 Months
Procedural time
Stopwatch
Measured: During surgery
Post-operative pain
Visual analogue scale (Santos, Botelho et al. 2021) (0-10) 0=No discomfort 10=Worst discomfort
Measured: 1 week
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)
Measured: 2 weeks
Incidence of complications
Checklist
Measured: 4 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Mar 2024
- Study startMay 2025 (estimated)
- Primary completionSep 2025 (estimated)
- Study completionOct 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alveolar Bone LossStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Youssef Emad Zaghloul Meshreky, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06315413
- Sponsor's protocol ID
- Composite plug vs d-PTFE
- Status last verified
- Aug 2024
- First submitted
- 10 Mar 2024
- Last updated
- 26 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 26 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06315413
- Acronym / sponsor ID
- Composite plug vs d-PTFE
- Conditions
- Alveolar Bone Loss
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- May 2025 (estimated)
- Primary completion
- Sep 2025 (estimated)
- Study completion
- Oct 2025 (estimated)
- First posted
- 18 Mar 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Composite plug | Experimental | Procedure: Socket 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-PTFE | Active comparator | Procedure: Socket 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. |
Who may qualify
- Ages
- 20 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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).
Key exclusion criteria (9 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Socket preservation using xenograft and composite plugExtraction 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. | Procedure or surgery | Composite plug |
| Socket preservation using xenograft and intentionally exposed d-PTFEExtraction 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. | Procedure or surgery | Exposed d-PTFE |
Primary outcome
Change in horizontal bone dimension
Time frame: 4 Months
Cone beam computed tomography (CBCT) (Millimeters)
6 secondary outcomes
Change in Vertical bone dimension
Time frame: 4 Months
Keratinized tissue thickness
Time frame: 4 Months
Procedural time
Time frame: During surgery
Post-operative pain
Time frame: 1 week
Patient Satisfaction
Time frame: 2 weeks
Incidence of complications
Time frame: 4 Months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Mar 2025.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Socket preservation using xenograft and composite plug and Socket preservation using xenograft and intentionally exposed d-PTFE in people with Alveolar Bone Loss, run by Cairo University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 26 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Youssef Meshreky, Master degree (+201006382121, youssefmeshreky@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in horizontal bone dimension (time frame: 4 Months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Mar 2025.