Ignite Creation Date:
2025-12-24 @ 11:02 PM
Ignite Modification Date:
2025-12-25 @ 8:33 PM
Study NCT ID:
NCT07053969
Status:
RECRUITING
Last Update Posted:
2025-11-12
First Post:
2025-06-27
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
The Effect Of Enamel Matrix Derivatives On Gingival Tissue Thickness
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000848', 'term': 'Anodontia'}, {'id': 'D055113', 'term': 'Chronic Periodontitis'}, {'id': 'D052016', 'term': 'Mucositis'}], 'ancestors': [{'id': 'D014071', 'term': 'Tooth Abnormalities'}, {'id': 'D018640', 'term': 'Stomatognathic System Abnormalities'}, {'id': 'D009057', 'term': 'Stomatognathic Diseases'}, {'id': 'D014076', 'term': 'Tooth Diseases'}, {'id': 'D000013', 'term': 'Congenital Abnormalities'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}, {'id': 'D010518', 'term': 'Periodontitis'}, {'id': 'D010510', 'term': 'Periodontal Diseases'}, {'id': 'D009059', 'term': 'Mouth Diseases'}, {'id': 'D002908', 'term': 'Chronic Disease'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D005759', 'term': 'Gastroenteritis'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT'], 'maskingDescription': 'Prior to the beginning of the surgical procedure, the PI will request that a faculty member not involved in the case randomly select a sealed envelope and hand it to the resident completing the procedure. The surgeon will not be blinded as it is not possible since only the experimental group will only receive the EMD.The patients will be blinded as to which group they are randomized into.'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'A two-arm randomized controlled trial'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 32}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-08-31', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-11', 'completionDateStruct': {'date': '2027-09', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-11-10', 'studyFirstSubmitDate': '2025-06-27', 'studyFirstSubmitQcDate': '2025-06-27', 'lastUpdatePostDateStruct': {'date': '2025-11-12', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-07-08', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-09', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Mucosal Thickness', 'timeFrame': 'One month and 3 months', 'description': 'Mucosal thickness at 1 and 5mm below the free gingival margin will be measured'}, {'measure': 'Change in Keratinized mucosal width', 'timeFrame': 'One month and 3 months', 'description': 'measurement of keratinized mucosal width at one and three months after surgical uncovering of the dental implant'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'keywords': ['Enamel Matrix Derivatives', 'EMD', 'Keratinized mucosa width', 'Mucosal thickness'], 'conditions': ['Dental Implantation', 'Missing Teeth', 'Periodontitis, Adult', 'Mucositis']}, 'descriptionModule': {'briefSummary': 'Scientists do research to answer important questions which might help change or improve the way we do things in the future.\n\nThe investigators know that using Enamel Matrix Derivatives results in thicker gum tissues around teeth. This study will test to see if using EMD around implants results in thicker gum tissues around implants.', 'detailedDescription': 'The hypothesis of the study is that the addition of EMD under the gingival flap prior to suturing will result in increased mucosal tissue thickness and increased keratinized tissue width as compared to not using the EMD.\n\nThe EMD will be deposited under the mucosal flap during the second stage implant uncovering. After flap suturing, an intraoral scan will be obtained. This procedure will require approximately 5 - 10 minutes per patient. All patients will be followed up at 14 days for suture removal per standard of care and not as part of the study. All patients will be followed up at one and three months per standard of care during which visits they will undergo an intraoral scan to allow evaluation of soft tissue dimensions. This is research only procedure that is expected to add 5 - 10 minutes to the regular postoperative visit. Study participation will be completed at the 3-month visit.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '18 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Ability of subject to understand and the willingness to sign a written informed consent document.\n2. Males and females; Age 18 to 89 years old\n3. Require second stage implant uncovering\n4. In either the maxillary or mandibular arch\n5. Has consistent transportation for all clinical and study visits\n\nExclusion Criteria:\n\n1. Pregnancy, or those planning to become pregnant\n2. Allergy or any medical issue using EMD\n3. Non-English speaking\n4. Patients on anticoagulants\n5. Patients who object to the use of animal products'}, 'identificationModule': {'nctId': 'NCT07053969', 'briefTitle': 'The Effect Of Enamel Matrix Derivatives On Gingival Tissue Thickness', 'organization': {'class': 'OTHER', 'fullName': 'The University of Texas Health Science Center at San Antonio'}, 'officialTitle': 'The Effect Of Enamel Matrix Derivatives On Gingival Tissue Thickness. A Randomized Controlled Trial.', 'orgStudyIdInfo': {'id': '00001758'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Group 1: Experimental Group using EMD', 'description': 'During implant uncovering the experimental group will receive EMD under the buccal flap', 'interventionNames': ['Device: Enamel Matrix Derivative']}, {'type': 'NO_INTERVENTION', 'label': 'Group 2: Control Group', 'description': 'No EMD is administered under the buccal flap during suturing'}], 'interventions': [{'name': 'Enamel Matrix Derivative', 'type': 'DEVICE', 'otherNames': ['EMD'], 'description': "EMD is an FDA approved medical device used in periodontal procedures since 1996. It has been shown to enhance soft and hard tissue healing, increased root coverage and aid in periodontal regeneration. It's use as an adjunct during implant uncovering may increase peri-implant mucosal thickness.", 'armGroupLabels': ['Group 1: Experimental Group using EMD']}]}, 'contactsLocationsModule': {'locations': [{'zip': '78229', 'city': 'San Antonio', 'state': 'Texas', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Angela A Palaiologou-Gallis, DDS., MS.', 'role': 'CONTACT', 'email': 'palaiologoua@uthscsa.edu', 'phone': '210-567-3567'}], 'facility': 'University of Texas Health Science Center at San Antonio', 'geoPoint': {'lat': 29.42412, 'lon': -98.49363}}], 'centralContacts': [{'name': 'Angela Palaiologou-Gallis, DDS', 'role': 'CONTACT', 'email': 'PalaiologouA@uthscsa.edu', 'phone': '210-450-3715'}], 'overallOfficials': [{'name': 'Angela Palaiologou-Gallis, DDS', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'The University of Texas Health Science Center at San Antonio'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'SAP'], 'timeFrame': 'At the conclusion of the study after data analysis is complete and the research is published in a peer reviewed journal', 'ipdSharing': 'YES', 'description': 'The PI will ensure all mechanisms used to share data will include proper plans and safeguards for the protection of privacy, confidentiality, and security for data dissemination and reuse (e.g., all data will be thoroughly de-identified and will not be traceable to a specific study participant). Plans for archiving and long-term preservation of the data will be implemented as appropriate.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'The University of Texas Health Science Center at San Antonio', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Angela Palaiologou-Gallis, DDS, MS', 'investigatorAffiliation': 'The University of Texas Health Science Center at San Antonio'}}}}