Effect of Hyaluronic Acid, With Demineralized Tooth Graft, in Socket Preservation, vs Demineralized Tooth Graft Alone.

NCT05613075 | Completed

• 1 other identifier: rahma.autograft
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Alveolar Bone Resorption; Socket Preservation; Bone Resorption; Unrestorable Dentition

Keywords

dentin graft; autogenous tooth graft; socket preservation; hyaluronic acid

Outcome Measures

Primary Outcomes (3)

• (BLRW)

  Bucco-lingual alveolar ridge width

  6 months

• (BRH)

  Height of Buccal ridge

  6 months

• (LRH).

  height of Lingual ridge

  6 months

Secondary Outcomes (4)

• Percentage of newly formed bone

  6 months

• soft tissue healing

  2 weeks

• residual graft

  6 months

• Visual analogue score (VAS)

  2 weeks

Study Arms (2)

tooth extraction and socket preservation with demineralized tooth graft

ACTIVE COMPARATOR

patients with immediate extraction sockets, filled and condensed with demineralized, autogenous dentinal graft particles, extracted and originated from the newly extracted tooth, then covered with biodegradable Gel foaming sponge.

Procedure: tooth extraction and socket preservation with demineralized tooth graft

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

EXPERIMENTAL

patients with immediate extraction sockets, filled and condensed with demineralized, autogenous dentinal graft particles, extracted and originated from the newly extracted tooth, mixed with Hyaluronic acid, in gel form, as a carrier, then covered with biodegradable Gel foaming sponge.

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

Interventions

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

tooth extraction and socket preservation with demineralized tooth graft with hyaluronic acid PROCEDURE

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

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

Eligibility Criteria

• Age: 21 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \. 18 years old or older.
• \. Requiring alveolar preservation after tooth extraction prior to placement of dental implant.
• \. 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).
• \. Motivated patients with good enough understanding of oral health measurements and importance.
• \. Sufficient keratinized gingiva to cover the grafted bone. 6. The presence of dentition adjacent to the bone defect.
• \. Patients who are healthy or have well-controlled systemic disease(s).
• \. Teeth extractions are to be recommended due to trauma, caries, or periodontal diseases. \* 9. Single rooted teeth from both arches.
• \. No acute infections, pus formation, socket and bony discharges.
• \. Hopeless teeth, to be extracted, are bounded both mesially and distally by adjacent, teeth.
• \. Intact buccal bone of the teeth to be extracted.

You may not qualify if:

• \. Heavy smokers (more than 10 cigarettes per day or an electronic cigarette dose of \>6 mg/ml of nicotine).
• \. Presence of active infection or severe inflammation in the intervention zone.
• \. Relevant medical history that contraindicates implant surgery.
• \. 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.
• \. 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.
• \. Uncontrolled diabetes (reported levels of glycated haemoglobin exceeding 7%).
• \. 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.
• \. Pregnant subjects.

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

Cairo university

Cairo, 12611, Egypt

Location

Related Publications (1)

• Hesham R, Shemais N, Saleh HA, Fawzy El-Sayed K. Autogenous Demineralized Dentin Graft With High Molecular Weight Hyaluronic Acid in Ridge Preservation: Pilot Trial. Clin Implant Dent Relat Res. 2025 Dec;27(6):e70100. doi: 10.1111/cid.70100.

  PMID: 41235610 DERIVED

MeSH Terms

Conditions

Bone Resorption

Interventions

Tooth Extraction; Hyaluronic Acid

Condition Hierarchy (Ancestors)

Bone Diseases; Musculoskeletal Diseases

Intervention Hierarchy (Ancestors)

Oral Surgical Procedures; Surgical Procedures, Operative; Dentistry; Glycosaminoglycans; Polysaccharides; Carbohydrates

Study Officials

• Rahma H Mohamed Ali

  Cairo University, Faculty of Dentistry

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: dentistry post graduate master student, Implantology Department

Study Record Dates

• First Submitted: November 4, 2022
• First Posted: November 14, 2022
• Study Start: December 1, 2022
• Primary Completion: October 30, 2024
• Study Completion: November 29, 2024
• Last Updated: June 5, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, CSR

Locations

EG (1)