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

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.

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.

Study Overview

• Status: Recruiting
• Conditions: Bone Resorption; Socket Preservation; Alveolar Bone Resorption
• Intervention / Treatment: Procedure: tooth extraction and socket preservation with demineralized tooth graft; Procedure: tooth extraction and socket preservation with demineralized tooth graft with hyaluronic acid

• Study Type: Interventional
• Enrollment (Anticipated): 26
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Rahma H Mohamed Ali; Phone Number: +20 01065800517; Email: rahma.ahmed@dentistry.cu.edu.eg

Study Locations

• Egypt
  • Cairo, Egypt, 12611
    • Recruiting
    • Cairo University
    • Contact: Rahma H Mohamed Ali, B.D.S; Phone Number: +202 23634965; Email: rec@dentistry.cu.edu.eg
    • Principal Investigator: Rahma H Mohamed Ali, B.D,S

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• 1. 18 years old or older.
• 2. Requiring alveolar preservation after tooth extraction prior to placement of dental implant.
• 3. 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).
• 4. Motivated patients with good enough understanding of oral health measurements and importance.
• 5. Sufficient keratinized gingiva to cover the grafted bone. 6. The presence of dentition adjacent to the bone defect.
• 7. Patients who are healthy or have well-controlled systemic disease(s).
• 8. Teeth extractions are to be recommended due to trauma, caries, or periodontal diseases. * 9. Single rooted teeth from both arches.
• 10. No acute infections, pus formation, socket and bony discharges.
• 11. Hopeless teeth, to be extracted, are bounded both mesially and distally by adjacent, teeth.
• 12. 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).
• 2. Presence of active infection or severe inflammation in the intervention zone.
• 3. Relevant medical history that contraindicates implant surgery.
• 4. 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.
• 7. 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.
• 9. Uncontrolled diabetes (reported levels of glycated haemoglobin exceeding 7%).
• 10. 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.
• 13. Pregnant subjects.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
(BLRW)	Bucco-lingual alveolar ridge width	6 months
(BRH)	Height of Buccal ridge	6 months
(LRH).	height of Lingual ridge	6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of newly formed bone		6 months
soft tissue healing	percentage of complete post operative wound closure by soft tissues	2 weeks
residual graft	percentage of residual bone graft particles	6 months
Visual analogue score (VAS)	Patient's pain and discomfort, 0-10 score, 0 represents "no pain", 10 represents "as bad as possible"	2 weeks

Collaborators and Investigators

• Sponsor: Cairo University
• Investigators: Principal Investigator: Rahma H Mohamed Ali, Cairo University, faculty of dentistry

Study record dates

Study Major Dates

• Study Start (Actual): December 1, 2022
• Primary Completion (Anticipated): June 15, 2023
• Study Completion (Anticipated): September 29, 2023

Study Registration Dates

• First Submitted: November 4, 2022
• First Submitted That Met QC Criteria: November 10, 2022
• First Posted (Actual): November 14, 2022

Study Record Updates

• Last Update Posted (Estimate): March 7, 2023
• Last Update Submitted That Met QC Criteria: March 6, 2023
• Last Verified: March 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Musculoskeletal Diseases; Bone Diseases; Bone Resorption; Physiological Effects of Drugs; Immunologic Factors; Protective Agents; Adjuvants, Immunologic; Viscosupplements; Hyaluronic Acid
• Other Study ID Numbers: rahma.autograft

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: 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