Ignite Creation Date:
2025-12-24 @ 3:28 PM
Ignite Modification Date:
2026-03-11 @ 12:59 PM
Study NCT ID:
NCT07139392
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-08-24
First Post:
2025-08-17
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Clinical Comparison of Connective Tissue Graft and Alb-PRF for Rebuilding Interdental Papilla
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D000418', 'term': 'Albumins'}], 'ancestors': [{'id': 'D011506', 'term': 'Proteins'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Sample Selection:\n\n* Inclusion Criteria:\n\n * Age 20-55 years\n * Nordland and Tarnow Class I/II papillary loss\n * Good oral hygiene (FMPS \\& FMBS \\<20%)\n * Systemically healthy\n* Exclusion Criteria:\n\n * Smoking\n * Periodontal pockets \\>4 mm in target site\n * History of systemic diseases or medications affecting healing\n * Pregnant or lactating women\n* Preoperative Phase:\n\n * Oral hygiene instruction\n * Phase I periodontal therapy\n * Initial photography and papillary height measurements using digital calipers or customized stents\n* Surgical Technique:\n\n * Local anesthesia\n * Intrasulcular incision around target teeth\n * Papilla preservation flap\n * Harvesting CTG from the palate\n * Injection of liquid Bio-PRF at the papillary base (test group)\n * CTG positioned in the papilla region\n * Suturing with microsurgical technique\n* Postoperative Protocol:\n\n * Analgesics (e.g., ibuprofen 400 mg)\n * Chlorhexidine 0.12% mouth rinse for 2 weeks\n * Suture removal at 10-14 days\n * Follow-up'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 30}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2025-09-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-08', 'completionDateStruct': {'date': '2025-09-23', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-08-17', 'studyFirstSubmitDate': '2025-08-17', 'studyFirstSubmitQcDate': '2025-08-17', 'lastUpdatePostDateStruct': {'date': '2025-08-24', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-08-24', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-09-20', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Papilla Height Gain', 'timeFrame': '6 months follow up', 'description': 'Papilla Height Gain (measured from contact point to papilla tip)'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['ALB-PRF', 'papilla', 'connective tissue', 'reconstruction', 'MINST'], 'conditions': ['Papilla Reconstruction']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'https://bmcoralhealth.biomedcentral.com/articles/10.1186/s12903-023-03525-7', 'label': 'Modified interproximal tunneling technique with customized sub-epithelial connective tissue graft for gingival papilla reconstruction: report of three cases with a cutback incision on the palatal side'}]}, 'descriptionModule': {'briefSummary': 'The interdental papilla, a small wedge of gingival tissue positioned between adjacent teeth, plays a crucial role in both dental esthetics and oral function. Loss or deficiency of the papilla results in the formation of "black triangles," which not only compromise a patient\'s smile but also lead to challenges such as food impaction, phonetic difficulties, and increased risk of periodontal disease. The reconstruction of the interdental papilla is recognized as one of the most challenging procedures in periodontal therapy, particularly when aiming for enhanced esthetic outcomes and patient satisfaction', 'detailedDescription': 'Connective tissue grafts (CTG) have traditionally been regarded as the gold standard for papilla reconstruction due to their predictable augmentation of soft tissues and stable long-term results. However, CTG procedures are invasive, requiring tissue harvesting from a donor site (often the palate), and are associated with increased surgical morbidity and discomfort for patients.\n\nAdvances in regenerative medicine have introduced minimally invasive alternatives, such as injectable biologically active platelet-rich fibrin (Bio-PRF). Bio-PRF is an autologous platelet concentrate containing a high concentration of growth factors, fibrin matrix, and immunomodulatory cells. The injectable form is designed to be applied directly into tissue-deficient papillary sites, promoting enhanced angiogenesis, cell proliferation, and tissue regeneration with minimal trauma and improved patient comfort.\n\nRecent clinical interest has focused on comparing these two approaches, CTG and injectable Bio-PRF, in their efficacy for papilla regeneration. While both techniques have demonstrated potential benefits, direct comparative studies are limited. Understanding the relative effectiveness, esthetic outcomes, surgical morbidity, and patient-centered results of these interventions is essential for evidence-based clinical decision making.\n\nThis clinical comparison seeks to evaluate and contrast the outcomes of connective tissue grafting and injectable Bio-PRF in the reconstruction of lost or compromised interdental papillae. The study aims to provide valuable insights into the optimal management of papillary defects, guiding periodontal practitioners toward treatments that maximize esthetic and functional results while minimizing patient morbidity.\n\nWe hypothesized that no significant difference between the treatment of interdental papilla with connective tissue graft or Bio-PRF.\n\nAim of the study\n\nPrimary Objective:\n\nTo assess the effectiveness of CTG combined with Bio-PRF in increasing papillary height in patients with papillary loss (Nordland and Tarnow Class I or II).\n\nSecondary Objectives:\n\n* To evaluate changes in patient satisfaction and aesthetic outcomes.\n* To assess soft tissue healing and clinical attachment gain.\n\nMaterials and methods:\n\nStudy Design:\n\n* Type: Randomized Controlled Clinical Trial\n* Duration: 6 months follow-up\n* Groups:\n\n * Group A (control): CTG alone\n * Group B (study): injectable Bio-PRF\n\nSample Selection:\n\n* Inclusion Criteria:\n\n * Age 20-55 years\n * Nordland and Tarnow Class I/II papillary loss\n * Good oral hygiene (FMPS \\& FMBS \\<20%)\n * Systemically healthy\n* Exclusion Criteria:\n\n * Smoking\n * Periodontal pockets \\>4 mm in target site\n * History of systemic diseases or medications affecting healing\n * Pregnant or lactating women\n* Preoperative Phase:\n\n * Oral hygiene instruction\n * Phase I periodontal therapy\n * Initial photography and papillary height measurements using digital calipers or customized stents\n* Surgical Technique:\n\n * Local anesthesia\n * Intrasulcular incision around target teeth\n * Papilla preservation flap\n * Harvesting CTG from the palate\n * Injection of liquid Bio-PRF at the papillary base (test group)\n * CTG positioned in the papilla region\n * Suturing with microsurgical technique\n* Postoperative Protocol:\n\n * Analgesics (e.g., ibuprofen 400 mg)\n * Chlorhexidine 0.12% mouth rinse for 2 weeks\n * Suture removal at 10-14 days\n * Follow-up at 1 month, 3 months, and 6 months\n\nOutcome Measures:\n\n* Primary Outcome:\n\n o Papilla Height Gain (measured from contact point to papilla tip)\n* Secondary Outcomes:\n\n * Visual Analog Scale (VAS) for aesthetic satisfaction\n * Healing Index\n * Black triangle area (measured via intraoral photographs or digital scanning)\n\nStatistical Analysis:\n\n* Descriptive statistics for baseline data\n* Paired t-test or Wilcoxon signed-rank test (intragroup comparison)\n* Independent t-test or Mann-Whitney U test (intergroup comparison)\n* p-value \\< 0.05 considered statistically significant'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '55 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age 20-55 years\n* Nordland and Tarnow Class I/II papillary loss\n* Good oral hygiene (FMPS \\& FMBS \\<20%)\n* Systemically healthy\n\nExclusion Criteria:\n\n* Smoking\n* Periodontal pockets \\>4 mm in the target site\n* History of systemic diseases or medications affecting healing\n* Pregnant or lactating women'}, 'identificationModule': {'nctId': 'NCT07139392', 'acronym': 'ALB-PRF & CTG', 'briefTitle': 'A Clinical Comparison of Connective Tissue Graft and Alb-PRF for Rebuilding Interdental Papilla', 'organization': {'class': 'OTHER', 'fullName': 'Minia University'}, 'officialTitle': 'A Clinical Comparison of Connective Tissue Graft and Alb-PRF for Rebuilding Interdental Papilla', 'orgStudyIdInfo': {'id': 'ALB -PRF in papilla'}, 'secondaryIdInfos': [{'id': 'committee 1165', 'type': 'OTHER', 'domain': 'ethical committee faculty of dentistry minia university'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'connective tissue graft', 'description': 'Semi-lunar flap elevation, then connective tissue graft sutured under the flap for papilla reconstruction', 'interventionNames': ['Biological: connective tissue graft']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'albumin-PRF', 'description': 'Albumin- PRF for papilla reconstruction', 'interventionNames': ['Biological: Albumin (5% serum-protein solution containing immunoglobulins)']}], 'interventions': [{'name': 'Albumin (5% serum-protein solution containing immunoglobulins)', 'type': 'BIOLOGICAL', 'otherNames': ['alb-prf'], 'description': '* Preoperative Phase:\n\n * Oral hygiene instruction\n * Phase I periodontal therapy\n * Initial photography and papillary height measurements using digital calipers or customized stents\n* Surgical Technique:\n\n * Local anesthesia\n * Intrasulcular incision around target teeth\n * Papilla preservation flap\n * Harvesting CTG from the palate\n * Injection of liquid Bio-PRF at the papillary base (test group)\n * CTG positioned in the papilla region\n * Suturing with microsurgical technique\n* Postoperative Protocol:\n\n * Analgesics (e.g., ibuprofen 400 mg)\n * Chlorhexidine 0.12% mouth rinse for 2 weeks\n * Suture removal at 10-14 days\n * Follow-up at 1 month, 3 months, and 6 months', 'armGroupLabels': ['albumin-PRF']}, {'name': 'connective tissue graft', 'type': 'BIOLOGICAL', 'description': 'Local anesthesia. Intrasulcular incision around target teeth. Papilla preservation flap. Harvesting CTG from the palate', 'armGroupLabels': ['connective tissue graft']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'shaimaa Hamdy, lecturer of Periodontology', 'role': 'CONTACT', 'email': 'shimaa.3m.sh@gmail.com', 'phone': '+201030576405', 'phoneExt': '+201555035523'}], 'overallOfficials': [{'name': 'shaimaa Hamdy, lecturer', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'lecturer of periodontology Nahda University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'After completing the study, I will share all the data of the study'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'shaimaa hamdy', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'lecturer of oral medicine, oral diagnosis and periodontology', 'investigatorFullName': 'shaimaa hamdy', 'investigatorAffiliation': 'Minia University'}}}}