NCT06716736

Brief Summary

The aim of this study will be to evaluate socket preservation using autogenous particulate dentin in combination with liquid platelet-rich fibrin versus bone allografts and collagen cone after surgical extraction of the horizontally impacted lower third molar

Trial Health

87
On Track

Trial Health Score

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

Enrollment
45

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Dec 2022

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2022

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 15, 2023

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2024

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

November 29, 2024

Completed
5 days until next milestone

First Posted

Study publicly available on registry

December 4, 2024

Completed
Last Updated

December 4, 2024

Status Verified

November 1, 2024

Enrollment Period

1 year

First QC Date

November 29, 2024

Last Update Submit

November 29, 2024

Conditions

Keywords

socket preservationdentine graft

Outcome Measures

Primary Outcomes (1)

  • bone resorption distal to second molar

    by measuring bone level immediate and 3 months after extraction on CBCT

    3 months after extraction

Secondary Outcomes (3)

  • bone density

    3 months after extraction

  • edema

    4 days after extraction

  • pain after surgical extraction

    4 days after extraction

Study Arms (3)

socket preservation with dentine graft mixed with liquid platelet rich fibrin (sticky tooth)

ACTIVE COMPARATOR

socket preservation with dentine graft mixed with liquid platelet rich fibrin (sticky tooth) after surgical extraction of horizontally impacted lower wisdom

Biological: socket preservation using dentine graft mixed with i-PRF

socket preservation with bone allograft

ACTIVE COMPARATOR

socket preservation with bone allograft after surgical extraction of horizontally impacted lower wisdom

Biological: socket preservation using bone allograft

socket preservation with collagen cone

ACTIVE COMPARATOR

socket preservation with collagen cone after surgical extraction of horizontally impacted lower wisdom

Biological: socket preservation using collagen cone

Interventions

surgical extraction of horizontally impacted third molar , placement of dentin graft mixed with i-PRF inside the socket , suturing

socket preservation with dentine graft mixed with liquid platelet rich fibrin (sticky tooth)

surgical extraction of horizontally impacted third molar , placement of bone allograft inside the socket , suturing

socket preservation with bone allograft

surgical extraction of horizontally impacted third molar , placement of collagen cone inside the socket , suturing

socket preservation with collagen cone

Eligibility Criteria

Age18 Years - 35 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Fresh extracted socket of horizontally impacted mandibular third molar
  • Co-operative patients willing to complete the follow-up periods.
  • Patients age from 18-35 years.
  • Good oral hygiene.

You may not qualify if:

  • Any pathological condition at the site of surgery.
  • Patients with systemic diseases that contra-indicate the surgical procedure such as uncontrolled diabetes mellitus, bleeding disorders, serious osseous disorders and mental disorders.
  • Smokers .
  • Pregnancy.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mansoura University

Al Mansurah, Eldakahlia, 35511, Egypt

Location

MeSH Terms

Interventions

proliferation regulatory factors, human urine

Study Officials

  • Wael M Ahmed, PHD

    mansoura uniersity

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Professor of Oral and Maxillofacial Surgery

Study Record Dates

First Submitted

November 29, 2024

First Posted

December 4, 2024

Study Start

December 1, 2022

Primary Completion

December 15, 2023

Study Completion

April 1, 2024

Last Updated

December 4, 2024

Record last verified: 2024-11

Data Sharing

IPD Sharing
Will not share

Locations