Alveolar Ridge PreservationNCT07394738
Using Different Biomaterials to Preserve Bone After Tooth Extraction
A study testing Allograft, Autogenous Dentin Graft and Hyaluronic Acid Gel in people with Alveolar Ridge Preservation and Bone Regeneration, run by Inonu University at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Alveolar Ridge Preservation, Bone Regeneration, Tooth Extraction
- What is being tested?
- Allograft, Autogenous Dentin Graft and Hyaluronic Acid Gel
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 9 Feb 2026to 30 Jun 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Show all 13Show fewer
- 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
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Inonu University Faculty of Dentistry
Malatya, Battalgazi-Malatya, 44280
About this study
Official title: Evaluating the Effectiveness of Various Biomaterials for Alveolar Socket Preservation
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.
Read the 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.
- Being tested
- Allograft, Autogenous Dentin Graft, Hyaluronic Acid Gel
- Keywords
- Alveolar Socket Preservation, Autogenous Dentin Graft, Socket Healing
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AllograftOther
Also called Freeze-dried allograft material
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.
Autogenous Dentin GraftOther
Also called Dentin particulate graft
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.
Hyaluronic Acid GelOther
Also called Hyaluronic acid (HA), HA 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.
| Study group | Role | What they receive |
|---|---|---|
| Allograft | Experimental | Participants receive an allograft material placed into the extraction socket. Healing and gingival parameters are assessed at predefined time points. Receives: 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. Receives: 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Bone Tissue Index
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.
Measured: At implant placement, 4 months after tooth extraction
Secondary outcomes (7)
Proportions of Osseous and Osteoid Tissue
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.
Measured: At implant placement, 4 months after tooth extraction
Osteocalcin and Osteopontin Immunoreactivity
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.
Measured: At implant placement, 4 months after tooth extraction
Change in buccopalatal ridge width on CBCT from baseline to 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.
Measured: Before tooth extraction and immediately before implant placement at 4 months.
Change in Mid-Buccal and Mid-Palatal Alveolar Ridge Height From Baseline to 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.
Measured: Before tooth extraction and immediately before implant placement at 4 months
Change in width of keratinized mucosa from baseline to 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.
Measured: Before tooth extraction and immediately before implant surgery at 4 months
Change in Buccal Soft Tissue Thickness From Baseline to 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.
Measured: Before tooth extraction and immediately before implant surgery at 4 months
Inflammatory Cell Infiltration Score
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.
Measured: At implant placement, 4 months after tooth extraction
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Feb 2026
- Study start9 Feb 2026
- Primary completion30 Jun 2026
- Study completion30 Jun 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alveolar Ridge PreservationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Four-arm randomized parallel study comparing allograft, autogenous dentin graft, dentin graft + hyaluronic acid, and natural healing in post-extraction sockets.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Inonu University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Okan Ozen, Inonu University
- Investigators
- okan özen, Principal investigator, Inonu UniversityArife Sabancı, Study chair, Inonu UniversityVesile E Toy, Study chair, Inonu University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07394738
- Sponsor's protocol ID
- TSA-2024-180
- Status last verified
- Oct 2026
- First submitted
- 27 Jan 2026
- Last updated
- 15 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be shared. The study involves a small, single-center clinical cohort, and the data include identifiable clinical imaging (CBCT scans and intraoral 3-D models) as well as histopathological specimens that cannot be fully anonymized without compromising data integrity. In addition, institutional and national regulations restrict redistribution of such data without additional ethics approval and explicit participant consent.
Study at a glance
From the registry record, last updated by the sponsor on 15 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluating the Effectiveness of Various Biomaterials for Alveolar Socket Preservation
- ClinicalTrials.gov ID
- NCT07394738
- Acronym / sponsor ID
- TSA-2024-180
- Keywords
- Alveolar Socket Preservation, Autogenous Dentin Graft, Socket Healing
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Inonu UniversityUniversity, hospital or other
- Study start
- 9 Feb 2026 (actual)
- Primary completion
- 30 Jun 2026 (actual)
- Study completion
- 30 Jun 2026 (actual)
- First posted
- 6 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 4
- Model description
- Four-arm randomized parallel study comparing allograft, autogenous dentin graft, dentin graft + hyaluronic acid, and natural healing in post-extraction sockets.
| Arm | Type | Receives |
|---|---|---|
| Allograft | Experimental | Other: AllograftParticipants receive an allograft material placed into the extraction socket. Healing and gingival parameters are assessed at predefined time points. |
| Dentin Graft | Experimental | Other: Autogenous Dentin GraftParticipants receive autogenous dentin graft material placed into the extraction socket. Healing and gingival parameters are assessed at predefined time points. |
| Dentin + Hyaluronic Acid | Experimental | Other: Autogenous Dentin Graft, Other: Hyaluronic Acid GelParticipants 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. |
| 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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- 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
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AllograftAlso: Freeze-dried allograft materialFollowing 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 | Allograft |
| Autogenous Dentin GraftAlso: Dentin particulate graftAfter 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 | Dentin + Hyaluronic Acid, Dentin Graft |
| Hyaluronic Acid GelAlso: Hyaluronic acid (HA), HA gelA 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 | Dentin + Hyaluronic Acid |
Primary outcome
Bone Tissue Index
Time frame: 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.
7 secondary outcomes
Proportions of Osseous and Osteoid Tissue
Time frame: At implant placement, 4 months after tooth extraction
Osteocalcin and Osteopontin Immunoreactivity
Time frame: At implant placement, 4 months after tooth extraction
Change in buccopalatal ridge width on CBCT from baseline to 4 months
Time frame: Before tooth extraction and immediately before implant placement at 4 months.
Change in Mid-Buccal and Mid-Palatal Alveolar Ridge Height From Baseline to 4 Months
Time frame: Before tooth extraction and immediately before implant placement at 4 months
Change in width of keratinized mucosa from baseline to 4 months
Time frame: Before tooth extraction and immediately before implant surgery at 4 months
Change in Buccal Soft Tissue Thickness From Baseline to 4 Months
Time frame: Before tooth extraction and immediately before implant surgery at 4 months
Inflammatory Cell Infiltration Score
Time frame: At implant placement, 4 months after tooth extraction
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Oct 2026.
- Individual participant dataSharing planned: No. Individual participant data will not be shared. The study involves a small, single-center clinical cohort, and the data include identifiable clinical imaging (CBCT scans and intraoral 3-D models) as well as histopathological specimens that cannot be fully anonymized without compromising data integrity. In addition, institutional and national regulations restrict redistribution of such data without additional ethics approval and explicit participant consent.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
okan özen principal investigator
Inonu University
Arife Sabancı study chair
Inonu University
Vesile E Toy study chair
Inonu University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Allograft, Autogenous Dentin Graft and Hyaluronic Acid Gel in people with Alveolar Ridge Preservation and Bone Regeneration, run by Inonu University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 13 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Bone Tissue Index (time frame: At implant placement, 4 months after tooth extraction). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Oct 2026.