The Effectiveness of Hyaluronic Acid in Bone Regeneration

NCT07031895 | Not Yet Recruiting

• 1 other identifier: 2025/184-F
• Study Type: interventional
• Target: 60
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Socket Preservation

Keywords

Socket Preservation; hyaluronic acid; bone formation

Outcome Measures

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.

  until the end of the histological examination 4 months after the socket preservation procedure

Secondary Outcomes (1)

• Radiographic bone evaluation

  up to the radiographic evaluations at 4 and 10 months after the socket preservation procedure

Study Arms (3)

Bovine-derived graft/xenograft enriched with hyaluronic acid study group

EXPERIMENTAL

Study group - Patients whose alveolar bone is pre-evaluated using cone-beam computed tomography (CBCT) will receive a bovine-derived graft/xenograft enriched with hyaluronic acid in the extraction socket after tooth removal. Patients will be evaluated clinically, radiologically, and histologically at 4 months. Dental implants will be placed in the edentulous areas where the graft was applied. Bone samples will be collected during the preparation of the implant sockets and analyzed histologically. A third CBCT scan will be performed 6 months after implant placement to radiographically assess new bone formation and implant success.

Combination Product: a bovine-derived graft/xenograft enriched with hyaluronic acid

Standard bovine-derived graft/xenograft comparison group

ACTIVE COMPARATOR

Comparison group - Patients whose alveolar bone is pre-evaluated using CBCT will receive a standard bovine-derived graft/xenograft in the extraction socket after tooth removal. Patients will be evaluated clinically, radiologically, and histologically at 4 months. Dental implants will be placed in the grafted areas. Bone samples will be collected during implant socket preparation and analyzed histologically. A third CBCT scan will be performed 6 months after implant placement to assess new bone formation and implant success.

Combination Product: a standart bovine-derived graft/xenograft

Control group without graft material

NO INTERVENTION

Control group - Patients whose alveolar bone is pre-evaluated using CBCT will undergo tooth extraction without graft material application, allowing for natural healing of the socket. Patients will be evaluated clinically, radiologically, and histologically at 4 months. Dental implants will be placed in the edentulous areas. Bone samples will be collected during the preparation of the implant sockets and analyzed histologically. A third CBCT scan will be performed 6 months after implant placement to assess new bone formation and implant success.

Interventions

a bovine-derived graft/xenograft enriched with hyaluronic acid COMBINATION_PRODUCT

In study group a bovine-derived graft/xenograft enriched with hyaluronic acid will be placed in the extraction socket after tooth removal.

Bovine-derived graft/xenograft enriched with hyaluronic acid study group

a standart bovine-derived graft/xenograft COMBINATION_PRODUCT

In comparison group a standard bovine-derived graft/xenograft will be placed in the extraction socket after tooth removal.

Standard bovine-derived graft/xenograft comparison group

Eligibility Criteria

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

You may qualify if:

• 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)
• Age range: 18-65 years
• Absence of active periodontal disease
• No systemic diseases
• Patients who will attend regular follow-up visits

You may not qualify if:

• Smoking
• Uncontrolled systemic disease
• Presence of infection in the area
• Use of medications affecting bone metabolism
• Pregnancy or lactation

Sponsors & Collaborators

• TC Erciyes University: lead

Related Publications (1)

• Kloss FR, Kau T, Heimes D, Kammerer PW, Kloss-Brandstatter A. Enhanced alveolar ridge preservation with hyaluronic acid-enriched allografts: a comparative study of granular allografts with and without hyaluronic acid addition. Int J Implant Dent. 2024 Oct 9;10(1):42. doi: 10.1186/s40729-024-00559-6.

  PMID: 39382763 BACKGROUND

Related Links

• Enhanced alveolar ridge preservation with hyaluronic acid-enriched allografts: a comparative study of granular allografts with and without hyaluronic acid addition
• Clinical and histologic outcomes of socket grafting after flapless tooth extraction: a systematic review of randomized controlled clinical trials
• Tissue changes of extraction sockets in humans: a comparison of spontaneous healing vs. ridge preservation with secondary soft tissue healing

MeSH Terms

Interventions

Hyaluronic Acid; Transplantation, Heterologous

Intervention Hierarchy (Ancestors)

Glycosaminoglycans; Polysaccharides; Carbohydrates; Transplantation; Surgical Procedures, Operative

Study Officials

• Duygu Kılıç, PhD

  Erciyes University Faculty of Dentistry Department of Periodontology

  STUDY DIRECTOR

• Fidan Gulıyeva, Research Assistant

  Erciyes University Faculty of Dentistry Department of Periodontology

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Duygu Kılıç, PhD

CONTACT

+903522076600; duygukilic4838@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD

Study Record Dates

• First Submitted: June 2, 2025
• First Posted: June 22, 2025
• Study Start: September 2, 2025
• Primary Completion: April 1, 2026
• Study Completion (Estimated): September 1, 2026
• Last Updated: August 20, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share