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

Bone Resorption Clinical Trial

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.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05613075
• Other study ID #: rahma.autograft
• Status: Recruiting
• Phase: N/A
• Start date: December 1, 2022
• Est. completion date: September 29, 2023

Study information

• Verified date: March 2023
• Source: Cairo University
• Contact: Rahma H Mohamed Ali
• Phone: 01065800517
• Email: rahma.ahmed[@]dentistry.cu.edu.eg
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 26
• Est. completion date: September 29, 2023
• Est. primary completion date: June 15, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 21 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Alveolar Bone Resorption
• Bone Resorption
• Socket Preservation

Intervention

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

Locations

Country	Name	City	State
Egypt	Cairo university	Cairo

Sponsors (1)

Lead Sponsor	Collaborator
Cairo University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	(BLRW)	Bucco-lingual alveolar ridge width	6 months
Primary	(BRH)	Height of Buccal ridge	6 months
Primary	(LRH).	height of Lingual ridge	6 months
Secondary	Percentage of newly formed bone		6 months
Secondary	soft tissue healing	percentage of complete post operative wound closure by soft tissues	2 weeks
Secondary	residual graft	percentage of residual bone graft particles	6 months
Secondary	Visual analogue score (VAS)	Patient's pain and discomfort, 0-10 score, 0 represents "no pain", 10 represents "as bad as possible"	2 weeks