Treatment of Peri-implant Bone Dehiscence Using Autogenous Tooth Plate

April 5, 2024 updated by: Walid Elamrousy, Kafrelsheikh University

Efficacy of Autogenous Tooth Plates for the Treatment of Peri-implant Bone Dehiscence Following Immediate Implantation in Maxillary Esthetic Zone: Randomized Clinical Trial

The current trial aim was to evaluate clinically and radiographically the changes around dental implants inserted immediately in maxillary anterior esthetic zone using a novel combination of autogenous demineralized tooth graft. with autogenous demineralized tooth plate and compared this approach to autogenous demineralized tooth graft.

The present study included 63 patients, aged 20 to 45, with teeth that needed to be extracted. After Kafrelsheikh University research ethics committee approval, patients were randomized into 3 groups: group I patients underwent immediate implantation with Duo-Teck membrane, while group II patients underwent the same procedure, but the dehisced bone defect was grafted by autogenous demineralized tooth graft. finally group III was grafted by combination of autogenous demineralized tooth graft. with autogenous demineralized tooth plate.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Patients with missing teeth face the prospect of tooth replacement either through the use of removable prostheses, fixed natural teeth-supported prostheses, or implant-supported prostheses. In many circumstances, implants are the alternative to fixed or removable prosthetic appliances.

One of the various indications of implant therapy is the replacement of periodontally hopeless teeth. The successful use of dental implants for more than 3 decades has been extensively documented for both conventional and immediate implant therapy.

The installation of implants in extraction sockets was advocated as a means to reduce the number of surgical procedures; to preserve the dimensions of the alveolar ridge; to reduce the interval between the removal of the tooth and the insertion of the implant supported restoration and furthermore, it may enhance osseointegration by taking advantage of the natural bone healing process around the implant.

A variety of regenerative techniques using combinations of bone grafts and barrier membranes have been suggested to promote bone regeneration in localized defects at implants placed into extraction sockets (Mayfield 1999). Bone substitutes were used to fill the marginal void between the implant and the bone, and barrier membranes were placed to protect the site during healing.

In the presence of fenestration or dehiscence defects, the potential for spontaneous bone formation at such defects is poor, so it is advised to use augmentation procedures for bone enhancement. Bone augmentation procedures are effective in promoting bone fill and defect resolution at implants placed in post-extraction sites, and are more successful with immediate and immediate-delayed placement than with conventional delayed placement.

The current trial aim was to evaluate clinically and radiographically the changes around dental implants inserted immediately in maxillary anterior esthetic zone using a novel combination of autogenous demineralized tooth graft. with autogenous demineralized tooth plate and compared this approach to autogenous demineralized tooth graft.

Study Type

Interventional

Enrollment (Estimated)

63

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 Contact

Study Contact Backup

Study Locations

  • Egypt
    • Kafrelsheikh
      • Kafr Ash Shaykh, Kafrelsheikh, Egypt, 214312

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

Yes

Description

Inclusion Criteria:

  • above the age of 18years
  • presence of non-restorable maxillary anterior tooth
  • had intact socket walls following tooth extraction
  • the gingival biotype was thick.

Exclusion Criteria:

  • history of systemic condition
  • history of using bisphosphonates or other drugs that might impact bone turnover
  • a history of smoking during the previous five years,
  • a history of any acute infections at the surgical site,
  • teeth having root resorptions

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: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Immediate Implant Placement Using duoteck membrane
after insertion of immediate implant, the dehisced bone defect will be grafted Using duoteck membrane
Procedure: duoteck membrane
the dehisced bone defect will be covered with duoteck membrane
Experimental: Immediate Implant Placement autogenous demineralized tooth graft
after insertion of immediate implant, the dehisced bone defect will be grafted Using autogenous demineralized tooth graft
Procedure: autogenous demineralized tooth graft
the dehisced bone defect will be covered with autogenous demineralized tooth graft
Experimental: Immediate Implant Placement with autogenous demineralized tooth graft and tooth plate
after insertion of immediate implant, the dehisced bone defect will be grafted Using autogenous demineralized tooth graft and autogenous demineralized tooth plate
Procedure: autogenous demineralized tooth graft and plate
the dehisced bone defect will be covered with autogenous demineralized tooth graft combined with autogenous demineralized tooth plate

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
pink esthetic score (PES)
Time Frame: 12-month.
The pink esthetic score (PES) evaluates the esthetic outcome of soft tissue around implant-supported single crowns in the anterior zone by awarding seven points for the mesial and distal papilla, soft-tissue level, soft-tissue contour, soft-tissue color, soft-tissue texture, and alveolar process deficiency.Using a 0-1-2 scoring system, 0 being the lowest, 2 being the highest value, the maximum achievable PES was 14
12-month.
facial marginal bone level (FMBL)
Time Frame: 12-month.
Utilizing CBCT sagittal sections, the BMBL was evaluated by computerized analysis. Navigation was done on the multiplanar display until the implant's precise same-view location was established on the reformatted cross-sectional section and panoramic view.
12-month.
Stability Quotient of dental implant (SQDI)
Time Frame: 12-month.
Osstell TM was used to record the primary stability.ISQ, or Implant Stability Quotient, is a scale from 1 to 100 and is a measure of the stability of an implant. The ISQ scale has a non-linear correlation to micro mobility. With more than 1400 scientific references, investigators now know that high stability means >70 ISQ, between 60-69 is medium stability and < 60 ISQ is considered as low stability.
12-month.

Collaborators and Investigators

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

Sponsor

Kafrelsheikh University

Investigators

  • Principal Investigator: Walid AH Elamrousy, PhD, Faculty of Oral and Dental Medicine, Kafrelsheikh University

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)

March 15, 2024

Primary Completion (Estimated)

March 30, 2025

Study Completion (Estimated)

April 15, 2025

Study Registration Dates

First Submitted

March 9, 2024

First Submitted That Met QC Criteria

March 9, 2024

First Posted (Actual)

March 15, 2024

Study Record Updates

Last Update Posted (Actual)

April 9, 2024

Last Update Submitted That Met QC Criteria

April 5, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • KFSIRB200-187

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

IPD Plan Description

undecided

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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