Ignite Creation Date:
2025-12-24 @ 10:21 PM
Ignite Modification Date:
2025-12-25 @ 7:53 PM
Study NCT ID:
NCT06871735
Status:
RECRUITING
Last Update Posted:
2025-03-12
First Post:
2025-03-06
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Acellular Collagen Matrix As a Tool to Obtain Wound Closure Following a Guided Bone Regeneration Procedure
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D058106', 'term': 'Wound Closure Techniques'}], 'ancestors': [{'id': 'D013514', 'term': 'Surgical Procedures, Operative'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 30}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2023-04-13', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-03', 'completionDateStruct': {'date': '2025-06-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-03-06', 'studyFirstSubmitDate': '2025-03-06', 'studyFirstSubmitQcDate': '2025-03-06', 'lastUpdatePostDateStruct': {'date': '2025-03-12', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-03-12', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-06-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Healing Score Index 8-10 days', 'timeFrame': '8-10 days following the surgical procedure', 'description': 'Healing Score Index (Pippi modification of Landry wound healing index):\n\n* presence/absence of redness;\n* presence/absence of granulation tissue;\n* presence/absence of suppuration;\n* presence/absence of swelling;\n* degree of tissue epithelialization (partial/complete);\n* presence/absence of bleeding;\n* presence/absence of pain on palpation.\n* presence/absence of plaque (% of plaque positive surfaces)\n\nAt first PO appointment'}, {'measure': 'Healing Score Index 6-8 weeks', 'timeFrame': '6-8 weeks following the surgical procedure', 'description': 'Healing Score Index (Pippi modification of Landry wound healing index):\n\n* presence/absence of redness;\n* presence/absence of granulation tissue;\n* presence/absence of suppuration;\n* presence/absence of swelling;\n* degree of tissue epithelialization (partial/complete);\n* presence/absence of bleeding;\n* presence/absence of pain on palpation.\n* presence/absence of plaque (% of plaque positive surfaces)\n\nAt second PO appointment'}, {'measure': 'Wound Healing 8-10 days', 'timeFrame': '8-10 days following the surgical procedure', 'description': 'Clinical wound healing will be scored as yes or no for each of the following wound healing parameters:\n\n* Mature wound healing, defined as complete wound closure without other significant findings.\n* Erythema, defined as increased redness compared to adjacent non-operated sites\n* Bleeding, defined as presence of spontaneous bleeding at the wound site\n* Graft mobility, defined as loose subgingival bone graft material evaluated by gentle palpation using a UNC-15 probe (if grafting was done during surgery)\n* Suppuration, defined as presence of pus or discharge at the wound site\n* Necrosis, defined as any visual soft and/or hard tissue necrosis at the wound site\n* Clinical wound exposure and closure and hydrogen peroxide test(+/-)\n\nAt first PO appointment'}, {'measure': 'Wound Healing 6-8 weeks', 'timeFrame': '6-8 weeks following the surgical procedure', 'description': 'Clinical wound healing will be scored as yes or no for each of the following wound healing parameters:\n\n* Mature wound healing, defined as complete wound closure without other significant findings.\n* Erythema, defined as increased redness compared to adjacent non-operated sites\n* Bleeding, defined as presence of spontaneous bleeding at the wound site\n* Graft mobility, defined as loose subgingival bone graft material evaluated by gentle palpation using a UNC-15 probe (if grafting was done during surgery)\n* Suppuration, defined as presence of pus or discharge at the wound site\n* Necrosis, defined as any visual soft and/or hard tissue necrosis at the wound site\n* Clinical wound exposure and closure and hydrogen peroxide test(+/-)\n\nAt second PO appointment'}], 'secondaryOutcomes': [{'measure': 'Change in ridge dimension', 'timeFrame': '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)', 'description': 'Ridge height and width, measured using the surgical template'}, {'measure': 'Patient experience - surgery', 'timeFrame': 'Day of surgical procedure', 'description': '* Discomfort level (0 = no; 1 = mild; 2 = moderate; 3 = severe)\n* Pain (0 = no pain; 1 = mild pain; 2 = moderate pain; 3 = severe pain) Any postsurgical issues reported'}, {'measure': 'Patient experience - 8-10 days PO', 'timeFrame': '8-10 days following the surgical procedure', 'description': '* Discomfort level (0 = no; 1 = mild; 2 = moderate; 3 = severe)\n* Pain (0 = no pain; 1 = mild pain; 2 = moderate pain; 3 = severe pain)\n* Swelling (0 = no pain; 1 = mild pain; 2 = moderate pain; 3 = severe pain)\n* The need for analgesics (0=none; 1= first 2 days; 2= first five days; 3= more than five days)\n* Any postsurgical issues reported\n\nAt first post-op appointment'}, {'measure': 'Patient experience - 6-8 weeks PO', 'timeFrame': '6-8 weeks following the surgical procedure', 'description': '* Discomfort level (0 = no; 1 = mild; 2 = moderate; 3 = severe)\n* Pain (0 = no pain; 1 = mild pain; 2 = moderate pain; 3 = severe pain)\n* Swelling (0 = no pain; 1 = mild pain; 2 = moderate pain; 3 = severe pain)\n* The need for analgesics (0=none; 1= first 2 days; 2= first five days; 3= more than five days)\n* Any postsurgical issues reported\n\nAt second post-op appointment'}, {'measure': 'Patient experience - implant appointment', 'timeFrame': '4-6 months following the surgical procedure', 'description': '* Discomfort level (0 = no; 1 = mild; 2 = moderate; 3 = severe)\n* Pain (0 = no pain; 1 = mild pain; 2 = moderate pain; 3 = severe pain)\n* Swelling (0 = no pain; 1 = mild pain; 2 = moderate pain; 3 = severe pain)\n* The need for analgesics (0=none; 1= first 2 days; 2= first five days; 3= more than five days)\n* Any postsurgical issues reported\n\nAt second post-op appointment'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['GBR', 'Bone graft', 'dental implant'], 'conditions': ['Bone Graft']}, 'descriptionModule': {'briefSummary': "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.\n\nAn 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.\n\nIn 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.\n\nParticipants 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.\n\nIt 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.\n\nFor 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.", 'detailedDescription': '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.\n\nSurgical 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.\n\nThis 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.\n\nResearch 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).\n\nObservation 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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '21 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': '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.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Have a missing tooth or teeth which are planned to be replaced with an implant\n* Need for guided bone regeneration procedure to increase the bone available for implant placement\n* Systemically healthy with no contraindications for bone grafting and/or implant surgery\n* No chronic sinus problems\n* Non-smoker\n* No need for removable temporary restorations during wound healing.\n\nExclusion Criteria:\n\n* Patients that have sufficient bone volume to perform implant placement through conventional drilling protocol without any pre-implant GBR procedure\n* Indications for pre-implant/pre-GBR soft tissue grafting procedure to increase existing soft tissue contours\n* The need to wear a removable temporary restoration during healing'}, 'identificationModule': {'nctId': 'NCT06871735', 'briefTitle': 'Acellular Collagen Matrix As a Tool to Obtain Wound Closure Following a Guided Bone Regeneration Procedure', 'organization': {'class': 'OTHER', 'fullName': 'Ohio State University'}, 'officialTitle': 'Acellular Collagen Matrix (Mucograft) As a Tool to Obtain Wound Closure Following GBR Procedures', 'orgStudyIdInfo': {'id': '2023H0107'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'With acellular matrix', 'description': 'Participants who are having the GBR procedure done with the use of the acellular matrix material to cover the graft/wound', 'interventionNames': ['Procedure: Acellular matrix']}, {'label': 'Surgical closure', 'description': 'Participants who are having the GBR procedure done by having the wound closed without the acellular material', 'interventionNames': ['Procedure: Surgical closure']}], 'interventions': [{'name': 'Acellular matrix', 'type': 'PROCEDURE', 'description': '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.', 'armGroupLabels': ['With acellular matrix']}, {'name': 'Surgical closure', 'type': 'PROCEDURE', 'description': '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.', 'armGroupLabels': ['Surgical closure']}]}, 'contactsLocationsModule': {'locations': [{'zip': '43210', 'city': 'Columbus', 'state': 'Ohio', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Binnaz Leblebicioglu, DDS, MS, PhD', 'role': 'CONTACT', 'email': 'leblebicioglu.1@osu.edu', 'phone': '614-292-0371'}], 'facility': 'The Ohio State University Graduate Periodontics Clinic', 'geoPoint': {'lat': 39.96118, 'lon': -82.99879}}], 'centralContacts': [{'name': 'Binnaz Leblebicioglu, DDS, MS, PhD', 'role': 'CONTACT', 'email': 'leblebicioglu.1@osu.edu', 'phone': '614-292-0371'}, {'name': 'Francesca Racca, DMD', 'role': 'CONTACT', 'email': 'racca.2@osu.edu', 'phone': '(614) 292-0371'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ohio State University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Binnaz Leblebicioglu', 'investigatorAffiliation': 'Ohio State University'}}}}