Clinical trial NCT05613075: Effect of Hyaluronic Acid, With Demineralized Tooth Graft, in Socket Preservation, vs Demineralized Tooth Graft Alone.
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.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Alveolar Bone Resorption
Socket Preservation
Bone Resorption
Unrestorable Dentition
Keywords: dentin graft
autogenous tooth graft
socket preservation
hyaluronic acid
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2022-11-14
Enrollment: 30
Sex: ALL
Minimum age (years): 21
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Detailed description: The available studies provide insufficient information to assess the efficacy of the usage of ha after tooth extraction in order to induce wound healing and accelerates bone deposition and differentiation. Hence, the purpose of this clinical trial is to investigate whether there is any beneficial value of local administration of 8% ha gel formulation (gengigel ®; farmalink saglik, istanbul, turkey) on the postoperative healing phase, bone density and ridge dimensions.

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 e-dentulous area.

Our null hypothesis that post-extraction ridges preserved with Hyaluronic acid mixed with autogenous tooth grafts will present no significant higher bone density at extraction site, nor better dimensional preservation of the ridge tooth/teeth socket(s), vertically and/or horizontally, than the normalized/standardized ridge preservation using autogenous tooth graft particulates alone, carried to serve delayed implants placement later on, at extraction sites.

Eligibility criteria: 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.

Primary outcomes:
measure: (BLRW)
timeFrame: 6 months
measure: (BRH)
timeFrame: 6 months
measure: (LRH).
timeFrame: 6 months
Secondary outcomes:
measure: Percentage of newly formed bone
timeFrame: 6 months
measure: soft tissue healing
timeFrame: 2 weeks
measure: residual graft
timeFrame: 6 months
measure: Visual analogue score (VAS)
timeFrame: 2 weeks
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Cairo university
Study officials:
affiliation: Cairo University, Faculty of Dentistry
name: Rahma H Mohamed Ali
role: PRINCIPAL_INVESTIGATOR
References: