Using Different Biomaterials to Preserve Bone After Tooth Extraction

NCT07394738 | Active Not Recruiting

• 1 other identifier: TSA-2024-180
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

This clinical study aims to evaluate the effectiveness of different biomaterials in alveolar socket preservation following tooth extraction. Participants will be allocated into three groups: (1) dentin graft, (2) dentin graft combined with hyaluronic acid, (3) allograft and (4) natural healing without any grafting material (control group). At 4 months post-extraction, dental implants will be placed, and bone biopsies will be obtained during the procedure. These biopsy samples will be subjected to histological analysis to assess new bone formation and graft integration. The study will contribute to the understanding of biomaterial performance in socket preservation prior to implant placement.

Conditions

Bone Regeneration; Tooth Extraction; Dental Implants; Alveolar Ridge Preservation

Keywords

Alveolar Socket Preservation; Autogenous Dentin Graft; Socket Healing

Outcome Measures

Primary Outcomes (1)

• Percentage of new bone formation in the extraction socket at 4 months

  Histomorphometric analysis will be performed on biopsies harvested from the preserved sockets. The percentage of newly formed mineralized bone will be calculated as the ratio of new bone area to the total tissue area within the region of interest. Higher values indicate more favorable hard tissue regeneration in the socket preservation site.

  4 months after tooth extraction

Secondary Outcomes (7)

• Percentage of residual graft material in the extraction socket at 4 months

  4 months after tooth extraction

• Percentage of new connective tissue in the extraction socket at 4 months

  4 months after tooth extraction

• Percentage of newly formed vascularized tissue in the extraction socket at 4 months

  4 months after tooth extraction

• Change in buccolingual ridge width on CBCT from baseline to 4 months

  Baseline and 4 months post-extraction

• Change in buccal soft tissue thickness measured by intraoral scanner

  Baseline and 4 months post-extraction

Study Arms (4)

Allograft

EXPERIMENTAL

Participants receive an allograft material placed into the extraction socket. Healing and gingival parameters are assessed at predefined time points.

Other: Allograft

Dentin Graft

EXPERIMENTAL

Participants receive autogenous dentin graft material placed into the extraction socket. Healing and gingival parameters are assessed at predefined time points.

Other: Autogenous Dentin Graft

Dentin + Hyaluronic Acid

EXPERIMENTAL

Participants receive a combination of autogenous dentin graft and hyaluronic acid placed into the extraction socket. Healing and gingival parameters are assessed at predefined time points.

Other: Autogenous Dentin Graft; Other: Hyaluronic Acid Gel

Natural Healing

NO INTERVENTION

Extraction sockets are left to heal without the application of graft or biomaterial. Healing and gingival outcomes are evaluated at predefined time points.

Interventions

Allograft OTHER

Following tooth extraction, the socket is filled with particulate freeze-dried allograft. The material is placed in a single session immediately after extraction to support socket preservation. Healing is monitored clinically at scheduled follow-up visits.

Also known as: Freeze-dried allograft material

Allograft

Hyaluronic Acid Gel OTHER

A hyaluronic acid gel is applied as an adjunct biomaterial in combination with dentin graft material during socket preservation. Tissue response is evaluated at scheduled follow-up visits.

Also known as: Hyaluronic acid (HA), HA gel

Dentin + Hyaluronic Acid

Autogenous Dentin Graft OTHER

After tooth extraction, autogenous dentin is processed into particulate graft form and placed into the socket in the same session. The graft is used for socket preservation, and healing is assessed clinically during planned follow-up visits.

Also known as: Dentin particulate graft

Dentin + Hyaluronic Acid; Dentin Graft

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Indicated for tooth extraction in the anterior or premolar region of the maxilla or mandible
• Planned socket preservation and subsequent dental implant placement at the extraction site
• Adequate bone volume permitting atraumatic extraction
• Good oral hygiene and periodontal status compatible with socket preservation
• Willing and able to attend scheduled follow-up visits and undergo biopsy collection prior to implant placement Able to provide written informed consent

You may not qualify if:

• Current use of medications affecting bone metabolism (e.g., bisphosphonates, corticosteroids, anti-resorptives)
• Active periodontal or periapical infection at the extraction site
• History of head and neck radiotherapy
• Smoking or tobacco use within the past 6 months
• Pregnancy or breastfeeding
• Known allergy or contraindication to grafting procedures or study-related materials
• Inability or unwillingness to comply with follow-up visits or biopsy procedures

Sponsors & Collaborators

• Inonu University: lead

Study Sites (1)

Inonu University Faculty of Dentistry

Malatya, Battalgazi-Malatya, 44280, Turkey (Türkiye)

Location

MeSH Terms

Interventions

Transplantation, Homologous; Hyaluronic Acid

Intervention Hierarchy (Ancestors)

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

Study Officials

• okan özen

  Inonu University Faculty of Dentistry

  PRINCIPAL INVESTIGATOR

• Arife Sabancı

  Inonu University Faculty of Dentistry

  STUDY CHAIR

• Vesile E Toy

  Inonu University Faculty of Dentistry

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: Histological evaluator will be blinded to group allocation.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Assistant

Model Details: Four-arm randomized parallel study comparing allograft, autogenous dentin graft, dentin graft + hyaluronic acid, and natural healing in post-extraction sockets.

Study Record Dates

• First Submitted: January 27, 2026
• First Posted: February 6, 2026
• Study Start: April 9, 2025
• Primary Completion: April 30, 2026
• Study Completion (Estimated): June 1, 2026
• Last Updated: March 27, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)