Socket Preservation Using Biodentin Versus Xeno Graft for Single Rooted Teeth

November 15, 2024 updated by: Maxim Salib Todry Gerges, Cairo University

Histomorphometric and Radiographic Assessment of Bone After Socket Preservation Using Biodentin Versus Xeno Graft for Socket Preservation of Single Rooted Mandibular Teeth: Randomized Clinical Trial

socket preservation using biodentin versus xeno graft for single rooted mandibular teeth

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

after extraction of single rooted mandibular teeth the socket will be filled with xeno graft or biodentine and the socket will be closed using gel foam and sutures then CBCT will be taken to measure bone width after 6 months of healing CBCT will be taken again to measure the difference in bone width and a core biopsy will be taken followed by implant placement

Study Type

Interventional

Enrollment (Estimated)

11

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

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:

  • Patients of both sex with badly decayed tooth indicated for extraction
  • The ages of the patients ranged from 25 to 50 years.
  • Patients with healthy systemic condition (Medically free)
  • Adequate inter-arch space for placement of the implant prosthetic part.
  • Good oral hygiene
  • Cooperative patients who are willing to commit for 6 months follow up

Exclusion Criteria:

  • Subjected to irradiation in the head and neck area less than 1 year before implantation.
  • Poor oral hygiene and motivation.
  • Smokers
  • Patient with medical condition that contraindicates surgical procedures
  • Pregnant or nursing.
  • Substance abuse.
  • Patients with habits that may jeopardize the implant longevity and affect the results of the study such as alcoholism or parafunctional habits severe bruxism or clenching.
  • Active infection or severe inflammation in the area intended for implant placement.
  • Patients on medication that may interfere with healing (corticosteroids, bisphosphonate, Chemo/radio therapy).

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: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: biodentine group
Drug: Biodentine
biodentine used in socket preservation
Active Comparator: xeno graft group
Drug: Biodentine
biodentine used in socket preservation

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
radiographic assessment to calculate bone width in millimeters after socket preservation in mandibular single rooted teeth using cone beam computed tomography
Time Frame: 6 months postoperative
calculation of bone width gain in millimeters in extraction socket in mandibular single rooted teeth using cone beam computed tomography.
6 months postoperative

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Histomorphometric analysis of bone after socket preservation in mandibular single rooted teeth harvested by trephine bur
Time Frame: 6 months postoperative
assessment of bone quality from extraction socket that were preserved bone will be harvested using trephine bur followed by implant placement
6 months postoperative

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Cairo University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

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 (Estimated)

December 1, 2024

Primary Completion (Estimated)

December 1, 2025

Study Completion (Estimated)

December 1, 2025

Study Registration Dates

First Submitted

November 8, 2024

First Submitted That Met QC Criteria

November 15, 2024

First Posted (Estimated)

November 19, 2024

Study Record Updates

Last Update Posted (Estimated)

November 19, 2024

Last Update Submitted That Met QC Criteria

November 15, 2024

Last Verified

November 1, 2024

More Information

Terms related to this study

Other Study ID Numbers

  • CEBD_CU_2024-01-26

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

product manufactured in and exported from the U.S.

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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