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NCT Number: NCT07394738

Using Different Biomaterials to Preserve Bone After Tooth Extraction

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Alveolar Ridge Preservation Bone Regeneration Dental Implants Tooth Extraction

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Inonu University Faculty of Dentistry

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

About this study

This randomized clinical trial is designed to evaluate the clinical and histological outcomes of different biomaterials used for alveolar socket preservation following tooth extraction. A total of 40 systemically healthy adult patients requiring tooth extraction in the non-molar region will be enrolled and randomly assigned to one of the following three groups (10 patients per group):

Group 1: Extraction socket filled with autogenous dentin graft.

Group 2: Extraction socket filled with autogenous dentin graft combined with hyaluronic acid.

Group 3: Extraction socket filled with allograft. Group 4 (Control): Extraction socket left to heal naturally without any graft material.

All patients will be re-evaluated at 4 months post-extraction, at which time dental implant placement will be performed. During the implant surgery, bone core biopsies will be taken from the grafted sites using a trephine bur for histological analysis. These specimens will be evaluated to assess new bone formation, residual graft material, inflammatory response, and overall bone quality.

Clinical parameters such as soft tissue healing, postoperative complications, and patient-reported outcomes will also be recorded throughout the healing period.

This study aims to compare the regenerative potential of dentin graft, allograft and dentin graft combined with hyaluronic acid, and to determine whether these materials can enhance socket healing and improve bone quality prior to implant placement.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Adults aged 18 years or older

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

Exclusion criteria

Systemic conditions known to impair bone or soft tissue healing (e.g., uncontrolled diabetes, immunosuppression, osteoporosis)

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

Treatment and study plan

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.

Other names: Freeze-dried allograft material

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.

Other names: Dentin particulate graft

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.

Other names: Hyaluronic acid (HA), HA gel

Primary outcomes

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

    Time frame: 4 months after tooth extraction

    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.

Secondary outcomes

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

    Time frame: 4 months after tooth extraction

    Histomorphometric evaluation will quantify the percentage of residual graft material within the preserved socket. The area occupied by residual graft particles will be expressed as a percentage of the total tissue area in the region of interest.

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

    Time frame: 4 months after tooth extraction

    Histopathological sections will be analyzed to determine the percentage of newly formed connective tissue within the preserved socket. The area of connective tissue will be expressed as a percentage of the total tissue area in the region of interest.

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

    Time frame: 4 months after tooth extraction

    Histomorphometric analysis will assess the proportion of vascularized tissue within the socket. Newly formed vascularized areas will be expressed as a percentage of the total tissue area in the region of interest, reflecting the degree of angiogenesis in the healing socket.

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

    Time frame: Baseline and 4 months post-extraction

    Standardized cone-beam computed tomography (CBCT) scans will be obtained at baseline (immediately after extraction) and at 4 months. Buccolingual ridge width will be measured at predefined levels, and the change in ridge width over time will be calculated (4 months minus baseline) for each site.

  5. Change in buccal soft tissue thickness measured by intraoral scanner

    Time frame: Baseline and 4 months post-extraction

    Digital intraoral scans will be obtained at baseline and at 4 months. Three-dimensional surface models will be superimposed, and buccal soft tissue thickness at the edentulous ridge will be quantified within a predefined region of interest. The change in thickness will be calculated as the difference between the 4-month and baseline measurements.

  6. Change in width of keratinized mucosa from baseline to 4 months

    Time frame: Baseline and 4 months post-extraction

    The width of keratinized mucosa at the edentulous site will be measured clinically using a periodontal probe at baseline and at 4 months. The change in keratinized mucosa width will be calculated as the difference between the 4-month and baseline measurements.

  7. Change in soft tissue thickness over the preserved socket from baseline to 4 months

    Time frame: Baseline and 4 months post-extraction

    Soft tissue thickness over the preserved socket will be measured using a periodontal probe or standardized transgingival measurement at baseline and at 4 months. The change in soft tissue thickness will be calculated as the difference between the 4-month and baseline values.

Sponsors and collaborators

Lead sponsor

Inonu University

Other

Registry information

Official study title

Evaluating the Effectiveness of Various Biomaterials for Alveolar Socket Preservation

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Feb 6, 2026
Registry last updated
Mar 27, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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