The Effectiveness of Hyaluronic Acid in Bone Regeneration
ConditionSocket Preservation
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-65
SponsorTC Erciyes University
About this trial
Bone loss due to resorption is commonly observed in the alveolar socket following tooth extraction. This situation makes it difficult to preserve sufficient bone volume that would allow for ideal implant placement in cases requiring dental implants. Alveolar ridge preservation is a procedure aimed at minimizing bone resorption and preserving the volume and morphology of the alveolar ridge after tooth extraction.
The aim of this study is to evaluate the clinical effectiveness of socket preservation using a xenograft enriched with hyaluronic acid in patients with defective extraction sockets.
This study is designed as a randomized, controlled clinical trial including three parallel groups:
Study group - Patients whose alveolar bone was evaluated using cone-beam computed tomography (CBCT) will undergo tooth extraction, followed by the application of a bovine-derived graft/xenograft enriched with hyaluronic acid into the socket. Patients will be evaluated clinically, radiologically, and histologically at the 4th month. Dental implants will be placed in the edentulous areas where the graft was applied. Bone samples will be taken during the preparation of the implant sockets, and the bone tissue will be examined histologically. A third CBCT scan will be taken 6 months after implant placement to assess new bone formation and implant success radiographically.
Comparison group - Patients whose alveolar bone was evaluated using CBCT will undergo tooth extraction, followed by the application of a standard bovine-derived graft/xenograft into the socket. Patients will be evaluated clinically, radiologically, and histologically at the 4th month. Dental implants will be placed in the edentulous areas where the graft was applied. Bone samples will be taken during the preparation of the implant sockets, and the bone tissue will be examined histologically. A third CBCT scan will be taken 6 months after implant placement to assess new bone formation and implant success radiographically.
Control group - Patients whose alveolar bone was evaluated using CBCT will undergo tooth extraction, and the socket will be left to heal naturally without the application of any graft material. Patients will be evaluated clinically, radiologically, and histologically at the 4th month. Dental implants will be placed in the edentulous areas. Bone samples will be taken during the preparation of the implant sockets, and the bone tissue will be examined histologically. A third CBCT scan will be taken 6 months after implant placement to assess new bone formation and implant success radiographically.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Socket type: Sockets with less than 50% bone resorption in the buccal and palatal/lingual walls according to the Kim JJ classification (Type I-IVa)
Disqualifiers
Smoking
Trial design
Design model
Parallel
Treatments tested in this trial
a bovine-derived graft/xenograft enriched with hyaluronic acid
Combination productIn study group a bovine-derived graft/xenograft enriched with hyaluronic acid will be placed in the extraction socket after tooth removal.
a standart bovine-derived graft/xenograft
Combination productIn comparison group a standard bovine-derived graft/xenograft will be placed in the extraction socket after tooth removal.
Treatment groups
60 Participants
are divided into 3 treatment groupsGroup A: Bovine-derived graft/xenograft enriched with hyaluronic acid study groupExperimental treatment 1 intervention
Group B: Standard bovine-derived graft/xenograft comparison groupActive comparator 1 intervention
Group C: Control group without graft materialNo intervention 0 interventions
Trial outcomes
Primary outcomes
1
bone formation
At the 4-month follow-up, dental implants will be placed in the edentulous areas where grafts were applied. During the preparation of the implant sockets, bone samples will be collected and examined histologically. Tissue samples obtained for histological examination will be fixed in a 10% formaldehyde solution for 72 hours. Following fixation, the tissues will undergo a decalcification process. After decalcification, a routine histological tissue processing protocol will be applied. The obtained histological images will be evaluated according to the classification by Jerry Bouquot. Tissues obtained from the study will also be analyzed using immunohistochemical staining under a light microscope (Olympus BX51, Tokyo, Japan). The sections will be examined under a light microscope (Olympus BX51, Tokyo, Japan). For all femoral sections obtained from subjects in the experimental groups, the intensity of AP and TRAP immunoreactivity will be calculated at 40× magnification using the ImageJ.
Time frame
until the end of the histological examination 4 months after the socket preservation procedureSecondary outcomes
1
Radiographic bone evaluation
Cone-beam computed tomography (CBCT) scans will be obtained from each patient at three different time points throughout the study: Before socket preservation At 4 months after socket preservation (prior to implantation) At 6 months after implantation Using these scans, bone density, vertical and horizontal gain parameters will be measured.
Time frame
up to the radiographic evaluations at 4 and 10 months after the socket preservation procedureLocations
Sponsors and contacts
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Source ClinicalTrials.gov
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