NCT06027528

Brief Summary

  • The aim of this interventional study is to investigate the dimensional changes in buccolingual alveolar ridge width in socket preservation using sticky dentin vs dentin graft alone
  • The main question: is dentin graft mixed with autologous fibrin glue has better dimensional changes than using dentin graft alone ?
  • outcomes: Change in buccolingual alveolar ridge width as well as apico-coronal alveolar ridge height

Trial Health

87
On Track

Trial Health Score

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

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Sep 2023

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

August 31, 2023

Completed
1 day until next milestone

Study Start

First participant enrolled

September 1, 2023

Completed
6 days until next milestone

First Posted

Study publicly available on registry

September 7, 2023

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 21, 2024

Completed
1.4 years until next milestone

Study Completion

Last participant's last visit for all outcomes

August 31, 2025

Completed
Last Updated

April 9, 2026

Status Verified

April 1, 2026

Enrollment Period

7 months

First QC Date

August 31, 2023

Last Update Submit

April 4, 2026

Conditions

Keywords

socket preservationalveolar ridge preservationdentin graftautologous fibrin gluesticky dentinsticky graft

Outcome Measures

Primary Outcomes (1)

  • Change in buccolingual alveolar ridge width dimensions immediately after tooth extraction (baseline) and ≥ 6 months after (follow-up).

    superimposition of the 2 CBCT and using Scans which will be exported as DICOM format to 3D viewer software

    6 month

Secondary Outcomes (1)

  • changes in apico-coronal alveolar ridge height immediately after tooth extraction and 6 months after

    6 months

Study Arms (2)

dentin graft mixed with autologous fibrin glue

EXPERIMENTAL

extracted tooth will be grinded into small particles to form dentin graft that will be mixed with autologous fibrin glue to be grafted in the extracted socket

Procedure: dentin graft mixed with autologous fibrin glue

dentin graft

ACTIVE COMPARATOR

extracted tooth will be grafted in the extracted socket

Procedure: dentin graft

Interventions

extracted tooth will be grinded into small particles to form dentin graft that will be mixed with autologous fibrin glue to be grafted in the extracted socket using centrifuge

dentin graft mixed with autologous fibrin glue
dentin graftPROCEDURE

extracted tooth will be grafted in the socket

dentin graft

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Systemically healthy patients ≥18 years old
  • Nonsmoker
  • Teeth with root fracture, teeth with failed endodontic therapy or advanced caries
  • Intact extraction socket with no dehiscence or fenestration.

You may not qualify if:

  • Patients with systemic diseases.
  • Patients with dehiscence or fenestrations
  • Patients with presence or history of osteonecrosis of the jaws, with use of bisphosphonates, exposure to head and neck radiation, chemotherapy.
  • Patients with large distinct pre-apical pathology
  • Smokers of more than 10 cigarettes a day or equivalent to cigarettes
  • Breastfeeding or pregnant women
  • Patients without availability to attend follow-up visits or patients rejecting to sign the informed consent.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cairo University

Cairo, 12012, Egypt

Location

Study Officials

  • Amr Zahran, Professor

    Cairo University

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Teaching assistant in periodontology department

Study Record Dates

First Submitted

August 31, 2023

First Posted

September 7, 2023

Study Start

September 1, 2023

Primary Completion

March 21, 2024

Study Completion

August 31, 2025

Last Updated

April 9, 2026

Record last verified: 2026-04

Locations