- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06716736
Socket Preservation After Surgical Extraction of Impacted Lower Third Molar
November 29, 2024 updated by: Wael Mohamed
Socket Preservation Using Autogenous Particulate Dentin in Combination With Liquid Platelet-rich Fibrin Versus Bone Allografts and Collagen Cones After Surgical Extraction of Impacted Lower Third Molar
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
Study Overview
Status
Completed
Conditions
Detailed Description
The aim of this study will be to evaluate socket preservation using autogenous particulate dentin in combination with liquid platelet-rich fibrin (sticky tooth) versus bone allografts and collagen cone after surgical extraction of the horizontally impacted lower third molar
Study Type
Interventional
Enrollment (Actual)
45
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Eldakahlia
-
Mansoura, Eldakahlia, Egypt, 35511
- Mansoura University
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
-
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: socket preservation with dentine graft mixed with liquid platelet rich fibrin (sticky tooth)
socket preservation with dentine graft mixed with liquid platelet rich fibrin (sticky tooth) after surgical extraction of horizontally impacted lower wisdom
|
surgical extraction of horizontally impacted third molar , placement of dentin graft mixed with i-PRF inside the socket , suturing
|
|
Active Comparator: socket preservation with bone allograft
socket preservation with bone allograft after surgical extraction of horizontally impacted lower wisdom
|
surgical extraction of horizontally impacted third molar , placement of bone allograft inside the socket , suturing
|
|
Active Comparator: socket preservation with collagen cone
socket preservation with collagen cone after surgical extraction of horizontally impacted lower wisdom
|
surgical extraction of horizontally impacted third molar , placement of collagen cone inside the socket , suturing
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
bone resorption distal to second molar
Time Frame: 3 months after extraction
|
by measuring bone level immediate and 3 months after extraction on CBCT
|
3 months after extraction
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
bone density
Time Frame: 3 months after extraction
|
using CBCT 3 month after extraction
|
3 months after extraction
|
|
edema
Time Frame: 4 days after extraction
|
by measuring distance between predetermined anatomical landmarks:
|
4 days after extraction
|
|
pain after surgical extraction
Time Frame: 4 days after extraction
|
using numerical rating scale
|
4 days after extraction
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Wael M Ahmed, PHD, mansoura uniersity
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
December 1, 2022
Primary Completion (Actual)
December 15, 2023
Study Completion (Actual)
April 1, 2024
Study Registration Dates
First Submitted
November 29, 2024
First Submitted That Met QC Criteria
November 29, 2024
First Posted (Estimated)
December 4, 2024
Study Record Updates
Last Update Posted (Estimated)
December 4, 2024
Last Update Submitted That Met QC Criteria
November 29, 2024
Last Verified
November 1, 2024
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- A08061222
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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