NCT06315413

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started May 2025

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 10, 2024

Completed
8 days until next milestone

First Posted

Study publicly available on registry

March 18, 2024

Completed
1.1 years until next milestone

Study Start

First participant enrolled

May 1, 2025

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2025

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2025

Completed
Last Updated

March 26, 2025

Status Verified

August 1, 2024

Enrollment Period

4 months

First QC Date

March 10, 2024

Last Update Submit

March 22, 2025

Conditions

Alveolar Bone Loss

Outcome Measures

Primary Outcomes (1)

  • Change in horizontal bone dimension

    Cone beam computed tomography (CBCT) (Millimeters)

    4 Months

Secondary Outcomes (6)

  • Change in Vertical bone dimension

    4 Months

  • Keratinized tissue thickness

    4 Months

  • Procedural time

    During surgery

  • Post-operative pain

    1 week

  • Patient Satisfaction

    2 weeks

  • +1 more secondary outcomes

Study Arms (2)

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.

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.

Procedure: Socket preservation using xenograft and intentionally exposed d-PTFE

Interventions

Socket preservation using xenograft and composite plugPROCEDURE

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.

Composite plug
Socket preservation using xenograft and intentionally exposed d-PTFEPROCEDURE

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.

Exposed d-PTFE

Eligibility Criteria

Age20 Years - 70 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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).

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faculty of oral and dental medicine, Cairo university

Cairo, Cairo Governorate, 4240310, Egypt

RECRUITING

MeSH Terms

Conditions

Alveolar Bone Loss

Condition Hierarchy (Ancestors)

Bone ResorptionBone DiseasesMusculoskeletal DiseasesPeriodontal AtrophyPeriodontal DiseasesMouth DiseasesStomatognathic Diseases

Central Study Contacts

Youssef Meshreky, Master degree

CONTACT

+201006382121youssefmeshreky@gmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant lecturer of Periodontology, Newgiza University

Study Record Dates

First Submitted

March 10, 2024

First Posted

March 18, 2024

Study Start

May 1, 2025

Primary Completion

September 1, 2025

Study Completion

October 1, 2025

Last Updated

March 26, 2025

Record last verified: 2024-08

Locations

EG(1)