Bone GraftNCT06871735
Acellular Collagen Matrix as a Tool to Obtain Wound Closure Following a Guided Bone Regeneration Procedure
An observational study of Bone Graft, run by Ohio State University at 1 site in United States.
Trial summary
Guided bone regeneration (GBR) is a procedure used to increase the amount of bone volume in the jaw before placing a dental implant. It is needed when a lot of bone has been lost around the spot where a tooth has been lost or extracted. Read more about this study
- Who is it for?
- Ages 21 to 75 years
- Conditions the study is for
- Bone Graft
- What is being tested?
- Acellular matrix and Surgical closure
- Type of treatment
- Surgery or procedure
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 13 Apr 2023to Oct 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 21 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Participants are patients at the Graduate Periodontics Clinic at The Ohio State University College of Dentistry who have been treatment-planned for a guided bone regeneration procedure prior to dental implant.
Who may be able to join
- Have a missing tooth or teeth which are planned to be replaced with an implant
- Need for guided bone regeneration procedure to increase the bone available for implant placement
- Systemically healthy with no contraindications for bone grafting and/or implant surgery
- No chronic sinus problems
- Non-smoker
- No need for removable temporary restorations during wound healing.
Who cannot join
- Patients that have sufficient bone volume to perform implant placement through conventional drilling protocol without any pre-implant GBR procedure
- Indications for pre-implant/pre-GBR soft tissue grafting procedure to increase existing soft tissue contours
- The need to wear a removable temporary restoration during healing
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
The Ohio State University Graduate Periodontics Clinic
Columbus, Ohio, 43210
Binnaz Leblebicioglu, DDS, MS, PhD, 614-292-0371, leblebicioglu.1@osu.edu
About this study
Official title: Acellular Collagen Matrix (Mucograft) as a Tool to Obtain Wound Closure Following GBR Procedures
Guided bone regeneration (GBR) is a procedure used to increase the amount of bone volume in the jaw before placing a dental implant. It is needed when a lot of bone has been lost around the spot where a tooth has been lost or extracted.
An incision is made, bone grafting material is placed in that spot, there is a membrane put over it as a barrier, then gum tissue has to be pulled back over it. Usually, this is enough to cover the whole wound, but sometimes the barrier membrane can't be covered with tissue the whole way without too much pulling, and the barrier membrane is still exposed.
Read more
In that case, one thing that can be done is to place another material, an acellular collagen matrix, over the barrier membrane and secure it there. This material has been shown to help with the healing in these cases.
Participants in this study will be clinic patients who have been determined to need a GBR procedure. Participants will get the GBR. If the barrier membrane is still exposed, then the acellular matrix material will be placed. This study will compare the healing outcomes and the success of the GBR depending on whether the acellular matrix material was used. The procedure itself is not part of the study. The only people in the study are patients who are already planning to have this procedure done as part of their dental care.
It is important to note that the research study will not affect the care that the patient is given, or whether or not the acellular matrix material is used. That will be decided by the dental surgeon who is treating them, based on their clinical judgement. The research study will only observe and compare the outcomes.
For the study, participants will have some additional clinical measurements made, besides the ones that are done as part of the follow-up care, and will be asked questions about their experience.
Read the detailed description
Implant treatment planning is restorative driven. Thus, hard and soft tissue contours should be carefully studied based on ideal restorative treatment outcome. Any deficiency in supporting tissues has to be treated by using Guided Bone Regeneration (GBR) prior to implant placement. As defined in the Glossary of Periodontal Terms, GBR is a surgical procedure with the goal of augmenting bone volume in edentulous or peri-implant areas using a barrier membrane, often in conjunction with bone grafting materials and/or biologics. Wound closure following guided bone regeneration (GBR) procedure is essential to establish and maintain wound stability which is critical for targeted increase in bone volume. This can be accomplished, in general, by performing periosteal releasing with/without vertical incisions and by coronally positioning the flap. This manipulation, in turn, may create shallower vestibulum, less attached gingiva and muscle pull close to newly established alveolar crest.
Surgical site will be anesthetized with routine local anesthesia protocol. Crestal incisions followed by sulcular and/or vertical incisions will be performed, and full thickness flap elevation will be performed to reach alveolar bone. Recipient site will be prepared through decortication of the bone surface, trimming, and adapting the cross-linked collagen membrane. Allograft alone or mixed with autograft and/or xenograft will be placed into defect based on case specific indications. Wound closure will be accomplished by suturing the edges of the wound. In some cases, conventional method of wound closure through periosteal releasing incision and coronally positioned flap is not possible due to anatomical limitations. Although not ideal, barrier membrane is left exposed during healing for these cases. We intend to cover these exposed areas with ACM (acellular matrix) as described in the literature to determine whether this approach differentially affects outcomes. Standard post-operative care protocols will be followed including post-operative prescriptions for antibiotics, analgesics and antiseptic mouth rinse.
This clinical study aims to compare these two techniques by evaluating the clinical outcomes of early wound healing. The working hypothesis is that the use of acellular collagen matrix prevents shallow vestibulum formation and secondary surgeries to overcome with soft tissue deficiencies compared to conventional surgical approach.
Research related procedures: - Radiographic/CBCT and clinical measurements and recording of the alveolar ridge prior to surgery (these are obtained as part of standard of care to evaluate the site during treatment planning for bone grafting then, later, for implant placement. We will be recording additional volumetric measurements by using these tools [same radiographic/CBCT documents] as part of the study). - Clinical measurements and recording of the alveolar ridge dimensions after flap elevation and after ridge augmentation. - Details of the surgery including bone quality (reported by surgeon), presence of buccal dehiscence/fenestration, the need of additional bone grafting of the ridge, the indications for barrier membrane placement. - Soft and hard tissue sampling at implant placement surgery (these tissues are generally discarded while opening space for implant fixture. We intend to keep them to study the quality of the regenerated tissues). - Questions to evaluate patient experience (pain and discomfort during and after surgery).
Observation period will be up to 4-6 months (until implant placement surgery) and wound healing will be evaluated through clinical parameters (8-10 days, 6-8 weeks and 4-6 months), implant stability (initial and 4-6 months) and CBCT (pre-surgical and 4-6 months ridge dimensions). These post-operative observation periods are a part of standard protocol. Each appointment may be 40 minutes longer than routine appointment due to research related measurements.
- Conditions
- Bone Graft
- Being tested
- Acellular matrix, Surgical closure
- Keywords
- GBR, Bone graft, dental implant
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Acellular matrixProcedure or surgery
Wound closure is obtained by use of acellular matrix material placed over the exposed barrier membrane. The procedure itself is not part of the research study, nor is the decision to use this procedure, but it is the condition of interest to the research.
Surgical closureProcedure or surgery
Wound from the graft is surgically closed, with no use of the acellular matrix. The procedure itself is not part of the research study, nor is the decision to use this procedure, but it is the condition of interest to the research.
| Study group | Role | What they receive |
|---|---|---|
| With acellular matrix | Participants who are having the GBR procedure done with the use of the acellular matrix material to cover the graft/wound Receives: Procedure: Acellular matrix | |
| Surgical closure | Participants who are having the GBR procedure done by having the wound closed without the acellular material Receives: Procedure: Surgical closure |
What is being measured
The primary outcome is the main question the study is designed to answer.
Healing Score Index 8-10 days
Healing Score Index (Pippi modification of Landry wound healing index):
- presence/absence of redness;
- presence/absence of granulation tissue;
- presence/absence of suppuration;
- presence/absence of swelling;
- degree of tissue epithelialization (partial/complete);
- presence/absence of bleeding;
- presence/absence of pain on palpation.
- presence/absence of plaque (% of plaque positive surfaces)
At first PO appointment
Measured: 8-10 days following the surgical procedure
Healing Score Index 6-8 weeks
Healing Score Index (Pippi modification of Landry wound healing index):
- presence/absence of redness;
- presence/absence of granulation tissue;
- presence/absence of suppuration;
- presence/absence of swelling;
- degree of tissue epithelialization (partial/complete);
- presence/absence of bleeding;
- presence/absence of pain on palpation.
- presence/absence of plaque (% of plaque positive surfaces)
At second PO appointment
Measured: 6-8 weeks following the surgical procedure
Wound Healing 8-10 days
Clinical wound healing will be scored as yes or no for each of the following wound healing parameters:
- Mature wound healing, defined as complete wound closure without other significant findings.
- Erythema, defined as increased redness compared to adjacent non-operated sites
- Bleeding, defined as presence of spontaneous bleeding at the wound site
- Graft mobility, defined as loose subgingival bone graft material evaluated by gentle palpation using a UNC-15 probe (if grafting was done during surgery)
- Suppuration, defined as presence of pus or discharge at the wound site
- Necrosis, defined as any visual soft and/or hard tissue necrosis at the wound site
- Clinical wound exposure and closure and hydrogen peroxide test(+/-)
At first PO appointment
Measured: 8-10 days following the surgical procedure
Wound Healing 6-8 weeks
Clinical wound healing will be scored as yes or no for each of the following wound healing parameters:
- Mature wound healing, defined as complete wound closure without other significant findings.
- Erythema, defined as increased redness compared to adjacent non-operated sites
- Bleeding, defined as presence of spontaneous bleeding at the wound site
- Graft mobility, defined as loose subgingival bone graft material evaluated by gentle palpation using a UNC-15 probe (if grafting was done during surgery)
- Suppuration, defined as presence of pus or discharge at the wound site
- Necrosis, defined as any visual soft and/or hard tissue necrosis at the wound site
- Clinical wound exposure and closure and hydrogen peroxide test(+/-)
At second PO appointment
Measured: 6-8 weeks following the surgical procedure
Secondary outcomes (5)
Change in ridge dimension
Ridge height and width, measured using the surgical template
Measured: Day of surgery, 1st PO appt (8-10 days post surgery), 2nd PO appointment (6-8 weeks post surgery), final appointment (4-6 months post surgery)
Patient experience - surgery
- Discomfort level (0 = no; 1 = mild; 2 = moderate; 3 = severe)
- Pain (0 = no pain; 1 = mild pain; 2 = moderate pain; 3 = severe pain) Any postsurgical issues reported
Measured: Day of surgical procedure
Patient experience - 8-10 days PO
- Discomfort level (0 = no; 1 = mild; 2 = moderate; 3 = severe)
- Pain (0 = no pain; 1 = mild pain; 2 = moderate pain; 3 = severe pain)
- Swelling (0 = no pain; 1 = mild pain; 2 = moderate pain; 3 = severe pain)
- The need for analgesics (0=none; 1= first 2 days; 2= first five days; 3= more than five days)
- Any postsurgical issues reported
At first post-op appointment
Measured: 8-10 days following the surgical procedure
Patient experience - 6-8 weeks PO
- Discomfort level (0 = no; 1 = mild; 2 = moderate; 3 = severe)
- Pain (0 = no pain; 1 = mild pain; 2 = moderate pain; 3 = severe pain)
- Swelling (0 = no pain; 1 = mild pain; 2 = moderate pain; 3 = severe pain)
- The need for analgesics (0=none; 1= first 2 days; 2= first five days; 3= more than five days)
- Any postsurgical issues reported
At second post-op appointment
Measured: 6-8 weeks following the surgical procedure
Patient experience - implant appointment
- Discomfort level (0 = no; 1 = mild; 2 = moderate; 3 = severe)
- Pain (0 = no pain; 1 = mild pain; 2 = moderate pain; 3 = severe pain)
- Swelling (0 = no pain; 1 = mild pain; 2 = moderate pain; 3 = severe pain)
- The need for analgesics (0=none; 1= first 2 days; 2= first five days; 3= more than five days)
- Any postsurgical issues reported
At second post-op appointment
Measured: 4-6 months following the surgical procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Mar 2025
- Study start13 Apr 2023
- Primary completionOct 2026 (estimated)
- Study completionOct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bone GraftStudies of the same condition, open and under way.
- More trials run by Ohio State UniversityThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ohio State University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Binnaz Leblebicioglu, Ohio State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06871735
- Sponsor's protocol ID
- 2023H0107
- Status last verified
- Feb 2026
- First submitted
- 6 Mar 2025
- Last updated
- 13 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Acellular Collagen Matrix (Mucograft) as a Tool to Obtain Wound Closure Following GBR Procedures
- ClinicalTrials.gov ID
- NCT06871735
- Acronym / sponsor ID
- 2023H0107
- Conditions
- Bone Graft
- Keywords
- GBR, Bone graft, dental implant
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Ohio State UniversityUniversity, hospital or other
- Study start
- 13 Apr 2023 (actual)
- Primary completion
- Oct 2026 (estimated)
- Study completion
- Oct 2026 (estimated)
- First posted
- 12 Mar 2025 (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.
Guided bone regeneration (GBR) is a procedure used to increase the amount of bone volume in the jaw before placing a dental implant. It is needed when a lot of bone has been lost around the spot where a tooth has been lost or extracted.
An incision is made, bone grafting material is placed in that spot, there is a membrane put over it as a barrier, then gum tissue has to be pulled back over it. Usually, this is enough to cover the whole wound, but sometimes the barrier membrane can't be covered with tissue the whole way without too much pulling, and the barrier membrane is still exposed.
In that case, one thing that can be done is to place another material, an acellular collagen matrix, over the barrier membrane and secure it there. This material has been shown to help with the healing in these cases.
Participants in this study will be clinic patients who have been determined to need a GBR procedure. Participants will get the GBR. If the barrier membrane is still exposed, then the acellular matrix material will be placed. This study will compare the healing outcomes and the success of the GBR depending on whether the acellular matrix material was used. The procedure itself is not part of the study. The only people in the study are patients who are already planning to have this procedure done as part of their dental care.
It is important to note that the research study will not affect the care that the patient is given, or whether or not the acellular matrix material is used. That will be decided by the dental surgeon who is treating them, based on their clinical judgement. The research study will only observe and compare the outcomes.
For the study, participants will have some additional clinical measurements made, besides the ones that are done as part of the follow-up care, and will be asked questions about their experience.
Detailed description
Implant treatment planning is restorative driven. Thus, hard and soft tissue contours should be carefully studied based on ideal restorative treatment outcome. Any deficiency in supporting tissues has to be treated by using Guided Bone Regeneration (GBR) prior to implant placement. As defined in the Glossary of Periodontal Terms, GBR is a surgical procedure with the goal of augmenting bone volume in edentulous or peri-implant areas using a barrier membrane, often in conjunction with bone grafting materials and/or biologics. Wound closure following guided bone regeneration (GBR) procedure is essential to establish and maintain wound stability which is critical for targeted increase in bone volume. This can be accomplished, in general, by performing periosteal releasing with/without vertical incisions and by coronally positioning the flap. This manipulation, in turn, may create shallower vestibulum, less attached gingiva and muscle pull close to newly established alveolar crest.
Surgical site will be anesthetized with routine local anesthesia protocol. Crestal incisions followed by sulcular and/or vertical incisions will be performed, and full thickness flap elevation will be performed to reach alveolar bone. Recipient site will be prepared through decortication of the bone surface, trimming, and adapting the cross-linked collagen membrane. Allograft alone or mixed with autograft and/or xenograft will be placed into defect based on case specific indications. Wound closure will be accomplished by suturing the edges of the wound. In some cases, conventional method of wound closure through periosteal releasing incision and coronally positioned flap is not possible due to anatomical limitations. Although not ideal, barrier membrane is left exposed during healing for these cases. We intend to cover these exposed areas with ACM (acellular matrix) as described in the literature to determine whether this approach differentially affects outcomes. Standard post-operative care protocols will be followed including post-operative prescriptions for antibiotics, analgesics and antiseptic mouth rinse.
This clinical study aims to compare these two techniques by evaluating the clinical outcomes of early wound healing. The working hypothesis is that the use of acellular collagen matrix prevents shallow vestibulum formation and secondary surgeries to overcome with soft tissue deficiencies compared to conventional surgical approach.
Research related procedures: - Radiographic/CBCT and clinical measurements and recording of the alveolar ridge prior to surgery (these are obtained as part of standard of care to evaluate the site during treatment planning for bone grafting then, later, for implant placement. We will be recording additional volumetric measurements by using these tools [same radiographic/CBCT documents] as part of the study). - Clinical measurements and recording of the alveolar ridge dimensions after flap elevation and after ridge augmentation. - Details of the surgery including bone quality (reported by surgeon), presence of buccal dehiscence/fenestration, the need of additional bone grafting of the ridge, the indications for barrier membrane placement. - Soft and hard tissue sampling at implant placement surgery (these tissues are generally discarded while opening space for implant fixture. We intend to keep them to study the quality of the regenerated tissues). - Questions to evaluate patient experience (pain and discomfort during and after surgery).
Observation period will be up to 4-6 months (until implant placement surgery) and wound healing will be evaluated through clinical parameters (8-10 days, 6-8 weeks and 4-6 months), implant stability (initial and 4-6 months) and CBCT (pre-surgical and 4-6 months ridge dimensions). These post-operative observation periods are a part of standard protocol. Each appointment may be 40 minutes longer than routine appointment due to research related measurements.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| With acellular matrix | – | Procedure: Acellular matrixParticipants who are having the GBR procedure done with the use of the acellular matrix material to cover the graft/wound |
| Surgical closure | – | Procedure: Surgical closureParticipants who are having the GBR procedure done by having the wound closed without the acellular material |
Who may qualify
- Ages
- 21 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Participants are patients at the Graduate Periodontics Clinic at The Ohio State University College of Dentistry who have been treatment-planned for a guided bone regeneration procedure prior to dental implant.
Key inclusion criteria (6 listed)
- Have a missing tooth or teeth which are planned to be replaced with an implant
- Need for guided bone regeneration procedure to increase the bone available for implant placement
- Systemically healthy with no contraindications for bone grafting and/or implant surgery
- No chronic sinus problems
- Non-smoker
Key exclusion criteria (3 listed)
- Patients that have sufficient bone volume to perform implant placement through conventional drilling protocol without any pre-implant GBR procedure
- Indications for pre-implant/pre-GBR soft tissue grafting procedure to increase existing soft tissue contours
- The need to wear a removable temporary restoration during healing
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 |
|---|---|---|
| Acellular matrixWound closure is obtained by use of acellular matrix material placed over the exposed barrier membrane. The procedure itself is not part of the research study, nor is the decision to use this procedure, but it is the condition of interest to the research. | Procedure or surgery | With acellular matrix |
| Surgical closureWound from the graft is surgically closed, with no use of the acellular matrix. The procedure itself is not part of the research study, nor is the decision to use this procedure, but it is the condition of interest to the research. | Procedure or surgery | Surgical closure |
Primary outcome
Healing Score Index 8-10 days
Time frame: 8-10 days following the surgical procedure
Healing Score Index (Pippi modification of Landry wound healing index): * presence/absence of redness; * presence/absence of granulation tissue; * presence/absence of suppuration; * presence/absence of swelling; * degree of tissue epithelialization (partial/complete); * presence/absence of bleeding; * presence/absence of pain on palpation. * presence/absence of plaque (% of plaque positive surfaces) At first PO appointment
Healing Score Index 6-8 weeks
Time frame: 6-8 weeks following the surgical procedure
Healing Score Index (Pippi modification of Landry wound healing index): * presence/absence of redness; * presence/absence of granulation tissue; * presence/absence of suppuration; * presence/absence of swelling; * degree of tissue epithelialization (partial/complete); * presence/absence of bleeding; * presence/absence of pain on palpation. * presence/absence of plaque (% of plaque positive surfaces) At second PO appointment
Wound Healing 8-10 days
Time frame: 8-10 days following the surgical procedure
Clinical wound healing will be scored as yes or no for each of the following wound healing parameters: * Mature wound healing, defined as complete wound closure without other significant findings. * Erythema, defined as increased redness compared to adjacent non-operated sites * Bleeding, defined as presence of spontaneous bleeding at the wound site * Graft mobility, defined as loose subgingival bone graft material evaluated by gentle palpation using a UNC-15 probe (if grafting was done during surgery) * Suppuration, defined as presence of pus or discharge at the wound site * Necrosis, defined as any visual soft and/or hard tissue necrosis at the wound site * Clinical wound exposure and closure and hydrogen peroxide test(+/-) At first PO appointment
Wound Healing 6-8 weeks
Time frame: 6-8 weeks following the surgical procedure
Clinical wound healing will be scored as yes or no for each of the following wound healing parameters: * Mature wound healing, defined as complete wound closure without other significant findings. * Erythema, defined as increased redness compared to adjacent non-operated sites * Bleeding, defined as presence of spontaneous bleeding at the wound site * Graft mobility, defined as loose subgingival bone graft material evaluated by gentle palpation using a UNC-15 probe (if grafting was done during surgery) * Suppuration, defined as presence of pus or discharge at the wound site * Necrosis, defined as any visual soft and/or hard tissue necrosis at the wound site * Clinical wound exposure and closure and hydrogen peroxide test(+/-) At second PO appointment
5 secondary outcomes
Change in ridge dimension
Time frame: Day of surgery, 1st PO appt (8-10 days post surgery), 2nd PO appointment (6-8 weeks post surgery), final appointment (4-6 months post surgery)
Patient experience - surgery
Time frame: Day of surgical procedure
Patient experience - 8-10 days PO
Time frame: 8-10 days following the surgical procedure
Patient experience - 6-8 weeks PO
Time frame: 6-8 weeks following the surgical procedure
Patient experience - implant appointment
Time frame: 4-6 months following the surgical procedure
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Feb 2026.
- Individual participant dataSharing planned: No
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Bone Graft, run by Ohio State University at 1 site in United States.
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 6 inclusion and 3 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: looking for participants now, as of the sponsor's last update on 13 Feb 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 United States. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Binnaz Leblebicioglu, DDS, MS, PhD (614-292-0371, leblebicioglu.1@osu.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Healing Score Index 8-10 days (time frame: 8-10 days following the surgical procedure). The study lists 4 primary outcomes in all. 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 13 Feb 2026.