Alveolar Ridge Preservation, Bone Regeneration, Tooth Extraction, Dental Implants
Conditions
Keywords
Alveolar Socket Preservation, Autogenous Dentin Graft, Socket Healing
Brief summary
This four-arm randomized controlled clinical trial evaluated the clinical, radiographic, and histological outcomes of different approaches to alveolar ridge preservation following tooth extraction. Forty systemically healthy adults requiring extraction of a maxillary non-molar tooth and subsequent implant placement were randomly allocated to autogenous dentin graft, autogenous dentin graft combined with hyaluronic acid, allograft, or spontaneous healing groups (n = 10/group). Clinical and cone-beam computed tomography assessments were performed at baseline and 4 months. During implant placement at 4 months, bone core biopsies were obtained from all study sites and subjected to histological, histomorphometric, and immunohistochemical analyses.
Detailed description
This single-center, four-arm randomized controlled clinical trial compared the clinical, radiographic, and histological outcomes of four approaches to alveolar ridge preservation. Forty systemically healthy adults requiring extraction of a maxillary non-molar tooth and subsequent implant placement were randomly assigned to one of four groups (n = 10/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 spontaneously without a graft material. Following minimally traumatic tooth extraction, the assigned graft material was placed in the socket according to group allocation, while no graft was used in the control group. All sockets were covered with a collagen sponge. Clinical measurements of keratinized tissue width and soft tissue thickness were obtained before tooth extraction and immediately before implant placement at the 4-month follow-up. Cone-beam computed tomography scans obtained before tooth extraction and immediately before implant placement at 4 months were used to evaluate changes in horizontal ridge width and vertical ridge height. During implant placement at 4 months, bone core biopsies were obtained from all study sites. The specimens were examined histologically and histomorphometrically to evaluate bone and connective tissue areas and indices, osseous and osteoid tissue proportions, and inflammatory cell infiltration. Osteocalcin and osteopontin immunoreactivity was assessed immunohistochemically. Postoperative healing and complications were monitored throughout the follow-up period.
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
SINGLE (Outcomes Assessor)
Masking description
Due to the nature of the interventions, the investigator who performed the surgical procedures and clinical assessments could not 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 extraction of a maxillary non-molar tooth, with subsequent implant placement planned at the extraction site. 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 |
|---|---|---|
| Bone Tissue Index | At implant placement, 4 months after tooth extraction | Bone tissue area and total tissue area was measured within a standardized analysis field in hematoxylin and eosin-stained bone core biopsy sections. The bone tissue index will be calculated as the ratio of bone tissue area to total tissue area and expressed as a percentage. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Proportions of Osseous and Osteoid Tissue | At implant placement, 4 months after tooth extraction | In Masson's trichrome-stained bone core biopsy sections, the areas occupied by osseous and osteoid tissue within the total bone tissue area were quantified and expressed as percentages. |
| Osteocalcin and Osteopontin Immunoreactivity | At implant placement, 4 months after tooth extraction | Osteocalcin and osteopontin immunoreactivity was evaluated in immunohistochemically stained bone core biopsy sections using the H-score method. Staining intensity and the percentage of positively stained cells will be combined to calculate an H-score ranging from 0 to 300 for each marker, with higher scores indicating greater immunoreactivity. |
| Change in buccopalatal ridge width on CBCT from baseline to 4 months | Before tooth extraction and immediately before implant placement at 4 months. | Standardized cone-beam computed tomography scans were obtained before tooth extraction and immediately before implant placement at the 4-month follow-up. Buccopalatal ridge width was measured between the outermost buccal and palatal cortical borders at 1, 3, and 5 mm apical to the most coronal aspect of the alveolar crest. Change was calculated as the 4-month value minus the baseline value and expressed in millimetres. |
| Change in Mid-Buccal and Mid-Palatal Alveolar Ridge Height From Baseline to 4 Months | Before tooth extraction and immediately before implant placement at 4 months | Mid-buccal and mid-palatal ridge heights were measured on standardized superimposed CBCT scans as the perpendicular distance between the most coronal point of the corresponding socket wall and a reference line passing through the most apical point of the socket. Change was calculated as the 4-month value minus the baseline value and expressed in millimetres. |
| Change in width of keratinized mucosa from baseline to 4 months | Before tooth extraction and immediately before implant surgery at 4 months | Keratinized tissue width was measured clinically at the mesio-buccal, mid-buccal, and disto-buccal aspects as the distance between the gingival or mucosal margin and the mucogingival junction. Change was calculated as the 4-month value minus the baseline value and expressed in millimetres. |
| Change in Buccal Soft Tissue Thickness From Baseline to 4 Months | Before tooth extraction and immediately before implant surgery at 4 months | Buccal soft tissue thickness was measured 3 mm apical to the gingival or mucosal margin using an endodontic spreader with a silicone stopper. The distance between the spreader tip and the stopper was measured with a digital calliper. Change was calculated as the 4-month value minus the baseline value and expressed in millimetres. |
| Inflammatory Cell Infiltration Score | At implant placement, 4 months after tooth extraction | Inflammatory cell infiltration was evaluated throughout the hematoxylin and eosin-stained bone core biopsy section using a four-point ordinal scale: 0, no infiltration; 1, mild or rare infiltration; 2, moderate or focal infiltration; and 3, severe or diffuse infiltration. |
Countries
Turkey (Türkiye)
Contacts
PRINCIPAL_INVESTIGATORokan özen
Inonu University
STUDY_CHAIRArife Sabancı
Inonu University
STUDY_CHAIRVesile E Toy
Inonu University
Outcome results
None listed