Tenting Abutment Technique Versus Screw"Tent-Pole" Technique for Augmentation of Posterior Atrophic Mandible

May 30, 2024 updated by: Alaa Mohmmed Salem Hafedh, Cairo University

A Comparative Study Between Tenting Abutment Technique Versus Screw"Tent-Pole" Technique for Augmentation of Posterior Atrophic Mandible Randomized Clinical Trial

To evaluate a novel method using a designed tenting abutment to reduce number of surgeries and the edentulous healing period is shortened. In addition, to prevent vertical and horizontal collapse of the bone graft and minimizes resorption of the bone graft during the healing the atrophic posterior mandible.

The tent pole provides excellent mechanical properties; stability & fixation, yet very poor features to preserve the integrity of the soft tissue.

Using the tenting abutment technique will help preserve the soft tissue and decrease the amount of dehiscence that might accompany the use of the tent pole.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Augmentation of insufficient bone volume can be brought about by different methods, including, particulate and block grafting materials, guided Bone Regeneration with or without growth and differentiation factors, ridge splitting, expansion and distraction osteogenesis, either alone or in combination. These techniques may be used for horizontal/vertical ridge augmentation.

Xenograft bone has been utilized for the reconstruction of large 3-dimensional defects because it has no donor site morbidity and is of an unlimited volume in quantity.

Guided bone regeneration (GBR) describes the use of membranes to regenerate bony defects. A membrane for GBR needs to be biocompatible, cell occlusive, non-toxic, moldable and possess space-maintaining properties including stability.

  • e. Explanation for choice of comparators (conventional titanium mesh): Tent pole offers superb mechanical properties for guided bone regeneration treatment in larger areas and it is regarded one of the most available covers for guided bone regeneration yet one of the cheapest.

    B. Objectives:

  • a. Aim of the study:

    • To evaluate the quantity of gained bone under tenting abutment compared to a tent pole.
    • To evaluate amount of wound dehiscence postoperatively using tenting abutment technique compared to a tent pole.
    • ·To optimize the anatomical situation in order to facilitate implant installation.

7b. Hypothesis:

  • Bone is a dynamic and living tissue with the capacity to repair and regenerate in response to injury. It is further possible to guide bone cells into an area that previously consisted of bony tissue to regenerate bone and increase the bone volume.
  • Tenting abutment is suitable as a biomaterial for creating a space between the bone cortex and the periosteum to enhance new bone regeneration.
  • Tenting abutment material will enhance the quantity and quality of newly formed bone.

  • Tenting abutment will cause less soft tissue dehiscence and will dramatically decrease the percentage of the collapse of the space produced by the bone graft and minimizes resorption of the grafting material compared to the titanium mesh.

    7c. Primary and secondary objectives:

    1. Primary objective:

      Evaluate bone gained (height and width) and the period of time of healing in the atrophic posterior mandible when using tenting abutment technique compared to tent pole.

    2. Secondary objectives:

Evaluation of soft tissue dehiscence and resorption of the grafting material that might occur using tent pole compared to the tenting abutment.

Study Type

Interventional

Enrollment (Estimated)

16

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 Locations

  • Egypt
      • Cairo, Egypt
        • Recruiting
        • Alaa Mohammed Hafedh
        • Contact:

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
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Patients with atrophic posterior mandible.
  • Both sexes.
  • No intraoral soft and hard tissue pathology.
  • No systemic condition that contraindicates implant placement

Exclusion Criteria:

  • Local criteria:

    • Untreated gingivitis, periodontitis.
    • Insufficient oral hygiene.
    • Previous radiation therapy for the head and neck neoplasia, or bone augmentation to implant site..

Systemic criteria:

  • Systemic disorders.
  • Heavy smoking of more than 20 cigarettes per day.
  • Bone pathology.
  • ·Psychiatric problems. Emotional instability. Unrealistic aesthetic demands.

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
Active Comparator: conventional group
Using a tent pole to gain bone in the atrophic posterior mandible.
Procedure: Tent pole technique
using the Tent pole technique to gain bone vertical and horizontal loss
Active Comparator: study group
Using a Tenting abutment to gain bone in the atrophic posterior mandible
Procedure: Tenting abutment technique
To evaluate a novel method using a designed tenting abutment to reduce number of surgeries and the edentulous healing period is shortened. In addition, to prevent vertical and horizontal collapse of the bone graft and minimizes resorption of the bone graft during the healing the atrophic posterior mandible.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
height gained and width gained
Time Frame: before and post operative four months
height gained and width gained Measure unit milimerter (mm) Measure device :CBCT
before and post operative four months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Soft tissue dehiscence
Time Frame: after one month
measure clinically (yes-no)
after one month

Collaborators and Investigators

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

Sponsor

Cairo University

Investigators

  • Study Director: Mohamed ahmed Farid shehab, professor, supervisor

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)

October 1, 2023

Primary Completion (Estimated)

July 1, 2024

Study Completion (Estimated)

October 1, 2024

Study Registration Dates

First Submitted

May 30, 2024

First Submitted That Met QC Criteria

May 30, 2024

First Posted (Actual)

June 5, 2024

Study Record Updates

Last Update Posted (Actual)

June 5, 2024

Last Update Submitted That Met QC Criteria

May 30, 2024

Last Verified

June 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • OMFS (3-3-5)

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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