Alveolar Ridge Preservation, Bone Regeneration, Tooth Extraction, Dental Implants
Conditions
Keywords
Alveolar Socket Preservation, Autogenous Dentin Graft, Socket Healing
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.
Detailed description
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.
Interventions
OTHERAllograft
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.
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.
OTHERHyaluronic Acid Gel
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.
Sponsors
Inonu University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Masking description
Histological evaluator will be blinded to group allocation.
Intervention model description
Four-arm randomized parallel study comparing allograft, autogenous dentin graft, dentin graft + hyaluronic acid, and natural healing in post-extraction sockets.
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of new bone formation in the extraction socket at 4 months | 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
| Measure | Time frame | Description |
|---|---|---|
| Percentage of residual graft material in the extraction socket at 4 months | 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. |
| Percentage of new connective tissue in the extraction socket at 4 months | 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. |
| Percentage of newly formed vascularized tissue in the extraction socket at 4 months | 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. |
| Change in buccolingual ridge width on CBCT from baseline to 4 months | 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. |
| Change in buccal soft tissue thickness measured by intraoral scanner | 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. |
| Change in width of keratinized mucosa from baseline to 4 months | 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. |
| Change in soft tissue thickness over the preserved socket from baseline to 4 months | 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. |
Countries
Turkey (Türkiye)
Contacts
PRINCIPAL_INVESTIGATORokan özen
Inonu University Faculty of Dentistry
STUDY_CHAIRArife Sabancı
Inonu University Faculty of Dentistry
STUDY_CHAIRVesile E Toy
Inonu University Faculty of Dentistry
Outcome results
None listed