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.
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Cairo University
- Enrollment
- 30
- Locations
- 1
- Primary Endpoint
- (BLRW)
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Outcomes Assessor)
Eligibility Criteria
- Ages
- 21 Years to 65 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
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.
- •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. *
- •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).
- •Head and neck-irradiated patients in the past 5 years.
- •Regular intake of bisphosphonates, anticoagulants, or anti-inflammatories.
- •7. Chronic drug abuse or alcoholic habits.
- •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.
- •Patients who had previously received bone graft on the site to be operated.
- •Patients with significant comorbidity such as recent heart attack or coagulation disorder.
- •13. Pregnant subjects.
Arms & Interventions
tooth extraction and socket preservation with demineralized tooth graft
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.
Intervention: tooth extraction and socket preservation with demineralized tooth graft (Procedure)
tooth extraction and socket preservation with demineralized tooth graft and hyaluronic acid
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.
Intervention: tooth extraction and socket preservation with demineralized tooth graft with hyaluronic acid (Procedure)
Outcomes
Primary Outcomes
(BLRW)
Time Frame: 6 months
Bucco-lingual alveolar ridge width
(LRH).
Time Frame: 6 months
height of Lingual ridge
(BRH)
Time Frame: 6 months
Height of Buccal ridge
Secondary Outcomes
- Percentage of newly formed bone(6 months)
- residual graft(6 months)
- soft tissue healing(2 weeks)
- Visual analogue score (VAS)(2 weeks)
Investigators
Rahma Hesham Ahmed
dentistry post graduate master student, Implantology Department
Cairo University