Ignite Creation Date:
2026-03-26 @ 3:18 PM
Ignite Modification Date:
2026-03-27 @ 11:32 AM
Study NCT ID:
NCT07409558
Status:
RECRUITING
Last Update Posted:
2026-02-13
First Post:
2026-02-05
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
3D Digital Assessment of Soft Tissue Changes After Modified FGG
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, 'conditionBrowseModule': {'meshes': [{'id': 'D005889', 'term': 'Gingival Recession'}], 'ancestors': [{'id': 'D005882', 'term': 'Gingival Diseases'}, {'id': 'D010510', 'term': 'Periodontal Diseases'}, {'id': 'D009059', 'term': 'Mouth Diseases'}, {'id': 'D009057', 'term': 'Stomatognathic Diseases'}, {'id': 'D055093', 'term': 'Periodontal Atrophy'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 34}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-01-04', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-02', 'completionDateStruct': {'date': '2026-07-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2026-02-12', 'studyFirstSubmitDate': '2026-02-05', 'studyFirstSubmitQcDate': '2026-02-12', 'lastUpdatePostDateStruct': {'date': '2026-02-13', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-02-13', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-07-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Soft Tissue Volumetric Changes', 'timeFrame': 'Baseline, 1 month, 3 months, and 6 months', 'description': 'Volumetric changes of the recipient site will be evaluated using three-dimensional digital models obtained with an intraoral scanner. Volumetric differences will be calculated by superimposing follow-up scans (1, 3, and 6 months) onto the baseline reference model.'}], 'secondaryOutcomes': [{'measure': 'Creeping Attachment', 'timeFrame': 'Baseline, 1 month, 3 months, and 6 months', 'description': 'Creeping attachment will be assessed by linear measurements of coronal migration of the gingival margin relative to the baseline position using calibrated digital images and software analysis.'}, {'measure': 'Soft Tissue Thickness Gain', 'timeFrame': 'Baseline and 6 months postoperatively', 'description': 'Soft tissue thickness will be assessed using three-dimensional direct digital analysis by superimposing intraoral scanner-derived STL files. Horizontal soft tissue thickness measurements will be performed at 1 mm, 3 mm, and 5 mm apical to the baseline gingival margin. Soft tissue thickness gain will be calculated as the difference between baseline and 6-month measurements.'}, {'measure': 'Gingival Recession Depth', 'timeFrame': 'Baseline, 1 month, 3 months, and 6 months', 'description': 'Gingival recession depth will be measured as the distance from the cemento-enamel junction to the gingival margin using calibrated digital photographs.'}, {'measure': 'Width of Keratinized Tissue', 'timeFrame': 'Baseline, 1 month, 3 months, and 6 months', 'description': 'The width of keratinized tissue will be measured from the gingival margin to the mucogingival junction following iodine staining.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Modified Free Gingival Graft', 'Free Gingival Graft', 'Soft Tissue Volume', 'Three-Dimensional Digital Analysis'], 'conditions': ['Gingival Recession, Localized', 'Soft Tissue Volume Changes', 'Keratinized Tissue Deficiency']}, 'referencesModule': {'references': [{'pmid': '33819324', 'type': 'BACKGROUND', 'citation': 'Carcuac O, Derks J. Modified Free Gingival Graft Technique for Root Coverage at Mandibular Incisors: A Case Series. Int J Periodontics Restorative Dent. 2021 Mar-Apr;41(2):e37-e44. doi: 10.11607/prd.5398.'}, {'pmid': '36627509', 'type': 'BACKGROUND', 'citation': 'Carcuac O, Trullenque-Eriksson A, Derks J. Modified free gingival graft technique for treatment of gingival recession defects at mandibular incisors: A randomized clinical trial. J Periodontol. 2023 Jun;94(6):722-730. doi: 10.1002/JPER.22-0581. Epub 2023 Jan 30.'}], 'seeAlsoLinks': [{'url': 'https://kaek.ksu.edu.tr/', 'label': 'Kahramanmaraş Sütçü İmam University Clinical Research Ethics Committee'}]}, 'descriptionModule': {'briefSummary': 'The aim of this randomized controlled clinical trial is to evaluate the effects of conventional free gingival graft (FGG) and modified free gingival graft (ModFGG) techniques on soft tissue thickness, volumetric change, and creeping attachment in mandibular incisors using three-dimensional direct digital analysis. The study will include a total of 34 systemically healthy, non-smoking individuals with localized Cairo Class II gingival recession. Participants will be randomly assigned to the FGG (control) and ModFGG (test) groups. Clinical measurements will be performed before surgery and at 1, 3, and 6 months post-surgery. Soft tissue thickness and volumetric changes will be analyzed three-dimensionally by overlaying digital models obtained with an intraoral scanner. Gingival recession depth, keratinized tissue height, and creeping attachment will also be assessed. The aim is to provide clinical evidence regarding the effects of the modified free gingival graft technique on soft tissue stability and volumetric gains.', 'detailedDescription': 'Keratinized tissue deficiency and gingival recession are common mucogingival problems that may compromise periodontal health, esthetics, and patient comfort. Soft tissue grafting procedures are widely used to increase tissue thickness and volume and to achieve keratinized tissue augmentation. Among autogenous grafting techniques, free gingival grafts (FGG) are considered a predictable and reliable approach for enhancing soft tissue stability and long-term marginal tissue outcomes.\n\nDespite their effectiveness, conventional FGG procedures may exhibit postoperative shrinkage and volume reduction due to limited vascularization at the recipient site. To overcome this limitation, a modified free gingival graft (ModFGG) technique has recently been introduced. In this technique, a connective tissue pedicle flap harvested from the apical region of the recession defect is used to cover the exposed root surface prior to placement of the free gingival graft, with the aim of improving graft vascularization and enhancing wound healing. Although previous studies have reported favorable outcomes for ModFGG in terms of root coverage, keratinized tissue gain, and patient satisfaction, available evidence is largely based on two-dimensional clinical measurements.\n\nConventional methods used to assess soft tissue changes, such as periodontal probing, needles, and ultrasonic devices, are either invasive or limited to linear measurements, thereby restricting the evaluation of volumetric tissue alterations. Recent advances in three-dimensional digital analysis techniques allow for reliable, non-invasive, and reproducible assessment of both linear and volumetric soft tissue changes. However, to date, no clinical study has evaluated soft tissue thickness, volumetric changes, and creeping attachment following conventional FGG and ModFGG procedures in mandibular incisors using direct three-dimensional digital analysis.\n\nThis randomized controlled clinical trial aims to compare the effects of conventional free gingival graft and modified free gingival graft techniques on soft tissue thickness, volumetric changes, and creeping attachment in mandibular incisors using a direct three-dimensional digital evaluation method. Systemically healthy, non-smoking adult patients presenting with localized Cairo Class II gingival recession will be enrolled and randomly allocated to either the FGG (control) group or the ModFGG (test) group.\n\nClinical and digital assessments will be performed at baseline and at 1, 3, and 6 months postoperatively. Soft tissue thickness and volumetric changes will be analyzed by superimposing digital models obtained using an intraoral scanner. Additional clinical parameters, including gingival recession depth, width of keratinized tissue, and probing depth, will also be recorded. The results of this study are expected to provide high-quality evidence regarding the effectiveness of the modified free gingival graft technique in enhancing soft tissue stability and volumetric outcomes in periodontal plastic surgery.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age 18 years or older\n* Systemically healthy individuals\n* Non-smokers\n* Presence of localized Cairo Class II gingival recession with a vertical recession depth of ≥3 mm on the buccal surfaces of mandibular incisors\n* Probing pocket depth of ≤3 mm at the tooth/teeth to be treated\n* No tooth mobility (mobility grade ≤1)\n* Absence of cervical composite restorations or non-carious cervical lesions\n* Presence of a shallow vestibule (\\<5 mm)\n\nExclusion Criteria:\n\n* Pregnancy or lactation\n* Untreated periodontal disease\n* Presence of parafunctional habits\n* Poor oral hygiene, defined as a full-mouth plaque score \\>20%\n* Malpositioned, rotated, or crowded teeth in the buccal position\n* Known systemic diseases (e.g., acquired immunodeficiency syndrome, diabetes mellitus)\n* Any condition or medication that may affect gingival wound healing\n* ASA physical status classification III or higher'}, 'identificationModule': {'nctId': 'NCT07409558', 'briefTitle': '3D Digital Assessment of Soft Tissue Changes After Modified FGG', 'organization': {'class': 'OTHER', 'fullName': 'Kahramanmaras Sutcu Imam University'}, 'officialTitle': 'Three-Dimensional Direct Digital Evaluation of Soft Tissue Volumetric Changes After Modified Free Gingival Graft Surgery: A Randomized Controlled Clinical Trial', 'orgStudyIdInfo': {'id': '2025/01'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Modified Free Gingival Graft (ModFGG)', 'description': 'Participants in this arm will receive a modified free gingival graft (ModFGG) procedure.\n\nA connective tissue pedicle flap will be prepared from the apical area of the recession defect and rotated coronally to cover the exposed root surface. A free gingival graft harvested from the palatal donor site will then be placed over the recipient area to enhance graft vascularization, soft tissue thickness, and volumetric stability.', 'interventionNames': ['Procedure: Modified Free Gingival Graft (ModFGG)']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Conventional Free Gingival Graft (FGG)', 'description': 'Participants in this arm will receive a conventional free gingival graft (FGG) procedure.\n\nA free gingival graft harvested from the palatal donor site will be placed onto a prepared recipient bed without the use of a connective tissue pedicle flap.', 'interventionNames': ['Procedure: Conventional Free Gingival Graft (FGG)']}], 'interventions': [{'name': 'Modified Free Gingival Graft (ModFGG)', 'type': 'PROCEDURE', 'description': 'A connective tissue pedicle flap is prepared from the apical area of the gingival recession defect and rotated coronally to cover the exposed root surface. Subsequently, a free gingival graft harvested from the palatal donor site is placed over the recipient area to enhance graft vascularization, soft tissue thickness, and volumetric stability.', 'armGroupLabels': ['Modified Free Gingival Graft (ModFGG)']}, {'name': 'Conventional Free Gingival Graft (FGG)', 'type': 'PROCEDURE', 'description': 'A free gingival graft harvested from the palatal donor site is placed onto a prepared recipient bed without the use of a connective tissue pedicle flap.', 'armGroupLabels': ['Conventional Free Gingival Graft (FGG)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '46000', 'city': 'Kahramanmaraş', 'state': 'Kahramanmaraş', 'status': 'RECRUITING', 'country': 'Turkey (Türkiye)', 'contacts': [{'name': 'esra bozkurt', 'role': 'CONTACT', 'email': 'dtesrabozkurt@gmail.com', 'phone': '+905533618725'}], 'facility': 'Kahramanmaraş Sütçü İmam University', 'geoPoint': {'lat': 37.5847, 'lon': 36.92641}}], 'centralContacts': [{'name': 'esra bozkurt', 'role': 'CONTACT', 'email': 'dtesrabozkurt@gmail.com', 'phone': '+905533618725'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'The collected data include detailed clinical and digital intraoral scan records that may compromise participant privacy and confidentiality. In addition, informed consent for public data sharing was not obtained from participants.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Kahramanmaras Sutcu Imam University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor', 'investigatorFullName': 'Esra Bozkurt', 'investigatorAffiliation': 'Kahramanmaras Sutcu Imam University'}}}}