Ignite Creation Date:
2026-03-26 @ 3:16 PM
Ignite Modification Date:
2026-03-30 @ 1:16 AM
Study NCT ID:
NCT07384403
Status:
RECRUITING
Last Update Posted:
2026-02-03
First Post:
2026-01-25
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Application of Topical Oxygen Therapy Around Customized Healing Collar
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, 'interventionBrowseModule': {'meshes': [{'id': 'D010100', 'term': 'Oxygen'}], 'ancestors': [{'id': 'D018011', 'term': 'Chalcogens'}, {'id': 'D004602', 'term': 'Elements'}, {'id': 'D007287', 'term': 'Inorganic Chemicals'}, {'id': 'D005740', 'term': 'Gases'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 6}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2026-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-01', 'completionDateStruct': {'date': '2026-09', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2026-01-25', 'studyFirstSubmitDate': '2026-01-25', 'studyFirstSubmitQcDate': '2026-01-25', 'lastUpdatePostDateStruct': {'date': '2026-02-03', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-02-03', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-07', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Soft tissue dimensional changes', 'timeFrame': 'baseline: preoperative and after 3 months and after 6 months', 'description': 'Horizontal Tissue Linear Alterations were measured in millimeters by superimposing baseline and follow-up 3D digital models and calculating the Mean Buccal Change (MBC) and Mean Total Change (MTC) using software such as ImageJ, Geomagic, or MeshLab at standardized buccal reference points.\n\nVertical Linear Tissue Alterations were quantified in millimeters by evaluating changes in Mesial Papillae Height Variation (mPHv), Distal Papillae Height Variation (dPHv), Papillae Height Variation (PHv), and Midfacial Height Variation (MFHv) through calibrated digital photography or intraoral scanning relative to fixed anatomical landmarks.'}, {'measure': 'Pink Esthetic Score (PES)', 'timeFrame': 'baseline: preoperative and after 3 months and after 6 months', 'description': 'determined by scoring seven soft tissue parameters (papillae, mucosal contour, level, color, and texture) from 0 to 2, based on clinical photographs compared with adjacent teeth, yielding a total score ranging from 0 to 14.'}], 'secondaryOutcomes': [{'measure': 'Postoperative Pain', 'timeFrame': 'baseline: at day 1 , day 3 , day 10', 'description': 'assesse using the Numerical Rating Scale (NRS), where patients rated their pain intensity from 0 (no pain) to 10 (worst imaginable pain), either verbally or through a visual analog form.'}, {'measure': 'Wound Healing', 'timeFrame': 'Baseline : day 1 , day 3 ,day 10', 'description': 'evaluated using the Modified Healing Index (MHI) as proposed by clinically scoring tissue color, swelling, exudate, necrosis, granulation, and epithelialization, with each parameter assigned a value and summed to reflect overall healing quality.'}]}, 'oversightModule': {'isUsExport': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Oxygen gel', 'volumetic change of soft tissue', 'implant'], 'conditions': ['Soft Tissue', 'Healing Abutment Influence on Gingival Volume', 'Soft Tissue Healing', 'Dental Implant Healing']}, 'descriptionModule': {'briefSummary': 'The preservation and enhancement of peri-implant soft tissues are essential for the long-term success and esthetic integration of dental implants. Customized healing abutments have been introduced to support individualized soft tissue shaping; however, optimizing soft tissue healing around implants remains a clinical challenge. Oxygen plays a critical role in wound healing by promoting angiogenesis, fibroblast proliferation, and collagen synthesis. Topical oxygen therapy has shown promise in accelerating tissue regeneration, yet its application in oral implantology, particularly in conjunction with customized healing abutments, has not been adequately studied. This study aims to provide clinical evidence regarding the effectiveness of topical oxygen therapy in improving linear and volumetric soft tissue changes around dental implants. The findings may guide clinicians in refining soft tissue management protocols and contribute to establishing evidence-based practices in implant dentistry.', 'detailedDescription': "Interventions\n\nPreoperative Measures Prior to the second-stage surgical procedure, all participants will undergo a standardized preoperative assessment to ensure their suitability for implant exposure and subsequent healing abutment placement.\n\nThe following components will be systematically conducted:\n\n1. Medical and Dental History Evaluation A comprehensive evaluation of each patient's medical and dental history will be performed to identify any systemic conditions or pharmacological agents that may compromise wound healing or elevate the risk of postoperative complications.\n2. Clinical and Radiographic Assessment A detailed clinical examination will be undertaken to evaluate the thickness of the soft tissue, the width of keratinized mucosa, and the condition of the mucosa overlying the implant site. Radiographic assessment using periapical radiographs or cone-beam computed tomography (CBCT), where indicated, will be conducted to confirm successful osseointegration of the dental implant and to exclude any evidence of peri-implant pathology.\n3. Oral Hygiene Evaluation and Instruction Oral hygiene status will be assessed using the Plaque Index. Patients will receive personalized oral hygiene instructions to ensure optimal plaque control before the surgical intervention. In cases where oral hygiene is deemed suboptimal, professional mechanical plaque removal (PMPR) will be provided, followed by re-evaluation prior to proceeding with the second-stage surgery.\n\nSurgical Protocol\n\nDuring the second-stage procedure, local anesthesia will be administered via infiltration using 2% lidocaine with 1:100,000 epinephrine. A mid-crestal or slightly palatal crestal incision will then be made to access the implant site.\n\nOnce osseointegration is clinically confirmed, the cover screw will be removed. Subsequently, a customized healing abutment(PEEK), appropriate to the implant diameter, will be placed and securely hand-tightened.\n\nApplication of Blue®M Gel:\n\nImmediately following the placement of the healing abutment, Blue®M oral gel (Blue®M Europe BV, theNetherlands) will be applied circumferentially around the healing collar using a sterile microbrush. The gel will be gently massaged into the peri-implant mucosa and left in situ.\n\nPostoperative instructions will include:\n\n* Patients will be advised to refrain from rinsing or brushing the treated area for the first 12 hours.\n* Blue®M gel application will be continued by the patient twice daily for 7 days postoperatively, in conjunction with standard oral hygiene measures.\n\nPostoperative Instructions and Follow-Up Patients will receive standard postoperative instructions and will be prescribed 0.12% chlorhexidine mouthwash to be used twice daily for one week. Analgesics (e.g., ibuprofen 400 mg) will be administered as needed. If sutures are used, they will be removed after 7-10 days.\n\nPatients will be clinically evaluated at baseline (day of second-stage surgery), day 7, and day 21 for the following:\n\nHorizontal and linear Soft tissue change ,Patient-reported outcomes (pain, discomfort),Digital photographs ."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '21 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adults aged 21 years and above.\n\n * Indicated for customized healing collar placement after second-stage surgery.\n * Good general health.\n * Able and willing to provide written informed consent.\n * Committed to follow-up visits.\n\nExclusion Criteria:\n\n* Individuals below 21 years old.\n* Systemic diseases affecting healing.\n* Smokers/tobacco users.\n* Pregnant/lactating women.\n* Medications affecting soft tissue healing.\n* Chemotherapy/radiotherapy patients.'}, 'identificationModule': {'nctId': 'NCT07384403', 'briefTitle': 'Application of Topical Oxygen Therapy Around Customized Healing Collar', 'organization': {'class': 'OTHER', 'fullName': 'Cairo University'}, 'officialTitle': 'Evaluation of Linear and Volumetric Soft Tissue Changes Following the Application of Topical Oxygen Therapy Around Customized Healing Collars: Case Series', 'orgStudyIdInfo': {'id': 'per3312026'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Topical Oxygen therapy', 'description': 'Participants will undergo a standardized preoperative assessment prior to second-stage implant surgery, including medical and dental history review, clinical and radiographic evaluation to confirm implant osseointegration, and oral hygiene assessment with reinforcement as needed.\n\nDuring the second-stage procedure, local anesthesia will be administered, followed by a crestal incision to access the implant site. After removal of the cover screw, a customized PEEK healing abutment will be placed.\n\nImmediately after abutment placement, Blue®M oral gel (Blue®M Europe BV, The Netherlands) will be applied around the healing collar and gently massaged into the peri-implant mucosa. Participants will continue topical application twice daily for 7 days.\n\nStandard postoperative care will be provided. Clinical evaluations will be performed at baseline, 7 days, and 21 days to assess soft tissue changes, patient-reported outcomes, and clinical photographs.', 'interventionNames': ['Procedure: topical oxygen therapy']}], 'interventions': [{'name': 'topical oxygen therapy', 'type': 'PROCEDURE', 'description': 'Participants will undergo a standardized preoperative assessment prior to second-stage implant surgery, including medical and dental history review, clinical and radiographic evaluation to confirm implant osseointegration, and oral hygiene assessment with reinforcement as needed. During the second-stage procedure, local anesthesia will be administered, followed by a crestal incision to access the implant site. After removal of the cover screw, a customized PEEK healing abutment will be placed. Immediately after abutment placement, Blue®M oral gel (Blue®M Europe BV, The Netherlands) will be applied around the healing collar and gently massaged into the peri-implant mucosa. Participants will continue topical application twice daily for 7 days. Standard postoperative care will be provided. Clinical evaluations will be performed at baseline, 7 days, and 21 days to assess soft tissue changes, patient-reported outcomes, and clinical photographs.', 'armGroupLabels': ['Topical Oxygen therapy']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Cairo', 'status': 'RECRUITING', 'country': 'Egypt', 'facility': 'Cairo university', 'geoPoint': {'lat': 30.06263, 'lon': 31.24967}}], 'centralContacts': [{'name': 'Mulhem ahmed, bachelor', 'role': 'CONTACT', 'email': 'mulhem.ahmad@dentistry.cu.edu.eg', 'phone': '00201050202633'}], 'overallOfficials': [{'name': 'Mulhem ahmed', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Cairo University'}, {'name': 'maie ismael', 'role': 'STUDY_CHAIR', 'affiliation': 'Cairo University'}, {'name': 'Mona Darhous', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Cairo University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Cairo University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator Mulhem Ahmad', 'investigatorFullName': 'Mulhem Ahmad', 'investigatorAffiliation': 'Cairo University'}}}}