Effect of Locally Applied Hyaluronic Acid, Mixed With Autogenous Demineralized Tooth Graft, for Socket Preservation, Versus Autogenous De-mineralized Tooth Graft.

Sponsor
Cairo University (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05613075
Collaborator
(none)
26
1
2
9.9
2.6

Study Details

Study Description

Brief Summary

Many dentists, clinicians and researchers have conducted numerous trials, and put several materials and procedures under the test, in an attempt to preserve vertical and/or horizontal extraction sockets dimensions. The clinical consequences of post-extraction remodeling may affect the outcome of the ensuing therapies aimed at restoring the lost dentition, either by limiting the bone availability for ideal implant placement or by compromising the aesthetic result of the prosthetic restorations. In an attempt for ridge/socket preservation of a freshly extracted tooth socket/bed, this study aims to assess and compare between using autogenous tooth graft added with Hyaluronic acid, and the usage of the standardized autogenous tooth graft alone, regarding the potency, preservative feature, and quality of bone healing, density, and deposition. For a better restorative outcome using a delayed implant placement later on in the edentulous area.

Condition or Disease Intervention/Treatment Phase
  • Procedure: tooth extraction and socket preservation with demineralized tooth graft
  • Procedure: tooth extraction and socket preservation with demineralized tooth graft with hyaluronic acid
N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
26 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
Potential Effect Assessment of Locally Applied Hyaluronic Acid, When Mixed With Autogenous De-mineralized Tooth Graft, for Socket Preservation, in Comparison With the Application of Autogenous De-mineralized Tooth Graft Alone.
Anticipated Study Start Date :
Dec 1, 2022
Anticipated Primary Completion Date :
Jun 15, 2023
Anticipated Study Completion Date :
Sep 29, 2023

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: tooth extraction and socket preservation with demineralized tooth graft

Procedure: tooth extraction and socket preservation with demineralized tooth graft
tooth extraction and socket preservation with demineralized tooth graft

Experimental: tooth extraction and socket preservation with demineralized tooth graft and hyaluronic acid

Procedure: tooth extraction and socket preservation with demineralized tooth graft with hyaluronic acid
tooth extraction and socket preservation with demineralized tooth graft with hyaluronic acid

Outcome Measures

Primary Outcome Measures

  1. (BLRW) [6 months]

    Bucco-lingual alveolar ridge width

  2. (BRH) [6 months]

    Height of Buccal ridge

  3. (LRH). [6 months]

    height of Lingual ridge

Secondary Outcome Measures

  1. Percentage of newly formed bone [6 months]

  2. soft tissue healing [2 weeks]

    percentage of complete post operative wound closure by soft tissues

  3. residual graft [6 months]

    percentage of residual bone graft particles

  4. Visual analogue score (VAS) [2 weeks]

    Patient's pain and discomfort, 0-10 score, 0 represents "no pain", 10 represents "as bad as possible"

Eligibility Criteria

Criteria

Ages Eligible for Study:
21 Years to 65 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
Inclusion Criteria:
    1. 18 years old or older.
    1. Requiring alveolar preservation after tooth extraction prior to placement of dental implant.
    1. Participants that are eligible for immediate implantation, yet having factors that are hindering these patients from immediate placement of an implant at the time of extraction (ex: Financial related factors - psychological factors - time related factors).
    1. Motivated patients with good enough understanding of oral health measurements and importance.
    1. Sufficient keratinized gingiva to cover the grafted bone. 6. The presence of dentition adjacent to the bone defect.
    1. Patients who are healthy or have well-controlled systemic disease(s).
    1. Teeth extractions are to be recommended due to trauma, caries, or periodontal diseases. * 9. Single rooted teeth from both arches.
    1. No acute infections, pus formation, socket and bony discharges.
    1. Hopeless teeth, to be extracted, are bounded both mesially and distally by adjacent, teeth.
    1. Intact buccal bone of the teeth to be extracted.
Exclusion Criteria:
    1. Heavy smokers (more than 10 cigarettes per day or an electronic cigarette dose of

6 mg/ml of nicotine).

    1. Presence of active infection or severe inflammation in the intervention zone.
    1. Relevant medical history that contraindicates implant surgery.
    1. Immunosuppression (eg. Hiv, solid-organ transplants). 5. Head and neck-irradiated patients in the past 5 years. 6. Regular intake of bisphosphonates, anticoagulants, or anti-inflammatories.
    1. Chronic drug abuse or alcoholic habits. 8. Patients with poor oral hygiene (full-mouth plaque score and full-mouth bleeding score >15%) and lack of motivation.
    1. Uncontrolled diabetes (reported levels of glycated haemoglobin exceeding 7%).
    1. Uncontrolled and /or untreated periodontal disease. 11. Patients who had previously received bone graft on the site to be operated. 12. Patients with significant comorbidity such as recent heart attack or coagulation disorder.
    1. Pregnant subjects.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Cairo university Cairo Egypt 12611

Sponsors and Collaborators

  • Cairo University

Investigators

  • Principal Investigator: Rahma H Mohamed Ali, Cairo University, Faculty of Dentistry

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Rahma Hesham Ahmed, dentistry post graduate master student, Implantology Department, Cairo University
ClinicalTrials.gov Identifier:
NCT05613075
Other Study ID Numbers:
  • rahma.autograft
First Posted:
Nov 14, 2022
Last Update Posted:
Nov 21, 2022
Last Verified:
Nov 1, 2022
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Nov 21, 2022