Ignite Creation Date:
2025-12-24 @ 5:09 PM
Ignite Modification Date:
2026-01-26 @ 3:39 PM
Study NCT ID:
NCT04376450
Status:
UNKNOWN
Last Update Posted:
2020-05-06
First Post:
2020-04-29
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Nonincised Papillae in the Treatment of Intrabony Defects.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010518', 'term': 'Periodontitis'}], 'ancestors': [{'id': 'D010510', 'term': 'Periodontal Diseases'}, {'id': 'D009059', 'term': 'Mouth Diseases'}, {'id': 'D009057', 'term': 'Stomatognathic Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR'], 'maskingDescription': 'a randomized, triple-blinded, parallel study'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'GROUP A: NONINCISED PAPILLAE SURGICAL APPROACH (NIPSA) GROUP B: ENTIRE PAPILLA PRESERVATION TECHNIQUE (EPP)'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 34}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2019-03-06', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-05', 'completionDateStruct': {'date': '2020-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2020-05-02', 'studyFirstSubmitDate': '2020-04-29', 'studyFirstSubmitQcDate': '2020-05-02', 'lastUpdatePostDateStruct': {'date': '2020-05-06', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-05-06', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'CLINICAL ATTACHMENT LEVEL (CAL)', 'timeFrame': 'Baseline to 6 months', 'description': 'measured from the cemento-enamel junction (CEJ) to the bottom of the pocket'}, {'measure': 'POCKET PROBING DEPTH (PPD)', 'timeFrame': 'Baseline to 6 months', 'description': 'from the gingival margin to the bottom of the pocket;'}, {'measure': 'Intrabony component (INTRA) of the defect', 'timeFrame': 'Baseline to 6 months', 'description': 'the distance from the most coronal extension of the interdental bone crest (BC) to the bottom of the defect (BD) (BC-BD).'}], 'secondaryOutcomes': [{'measure': 'Papilla loss (PL)', 'timeFrame': 'Baseline to 6 months', 'description': 'measured from contact point to tip of the papilla.'}, {'measure': 'Local bleeding score', 'timeFrame': 'Baseline to 6 months', 'description': 'recorded as positive when bleeding on probing was present at the surgical site.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Periodontitis; reconstructive surgical procedure;', 'guided tissue regeneration;', 'surgical flaps;treatment outcome'], 'conditions': ['Reconstructive Surgical Procedure']}, 'descriptionModule': {'briefSummary': 'The primary objective of the present study is to clinically and radiographically evaluate nonincised papillae surgical approach and entire papilla preservation approach for the treatment of intrabony defects with GTR membrane and hydroxyapatite graft.', 'detailedDescription': 'Various procedures to treat intrabony defects by preserving the interdental papilla include conventional, simplified, and modified papilla preservation techniques. The drawback of these techniques is the post-surgical gingival recession.\n\nIn order to overcome this drawback, the "entire papilla preservation" technique has been proposed, by preserving the whole integrity of the defect associated papilla providing a tunnel-like undermining incision. Recently a novel surgical procedure, termed nonincised papillae surgical approach (NIPSA), was designed to maintain the integrity of the interdental soft tissues covering intrabony defects. This would prevent biomaterial exposure associated with loss of papillary height, increase the amount of space for hard and soft tissue regeneration, and minimize gingival recession.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '30 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Systemically healthy individuals within an age group 30-60yrs with chronic periodontal disease.\n2. Presence of two or more intrabony defects with probing pocket depth ≥5mm, CAL≥5mm, and radiographic depth ≥4mm.\n3. Adequate attached gingiva of 3mm and vestibular depth of 8mm. -\n\nExclusion Criteria:\n\n1. Uncontrolled systemic disease.\n2. Pregnancy and lactation.\n3. Defects involving lingual sites.\n4. Presence of restoration in the experimental teeth.\n5. Smokers -'}, 'identificationModule': {'nctId': 'NCT04376450', 'briefTitle': 'Nonincised Papillae in the Treatment of Intrabony Defects.', 'organization': {'class': 'OTHER', 'fullName': 'SVS Institute of Dental Sciences'}, 'officialTitle': 'A Comparative Evaluation of Nonincised Papillae and Entire Papilla Preservation Surgical Approach in the Treatment of Intrabony Defects - a Clinical and Radiographic Study', 'orgStudyIdInfo': {'id': 'SVSIDS/PERIO/2/2018'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Nonincised Papillae Surgical Approach', 'description': 'Nonincised papillae surgical approach is a papillae preservation technique, where an apical approach is carried out, without incisions or disinsertion of tissues at the level of the papillae or marginal tissues.', 'interventionNames': ['Procedure: Experimental- Nonincised papillae surgical approach']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Entire Papilla Preservation Technique', 'description': 'Entire Papilla preservation technique is a tunnel-like procedure to preserve the defect associated papilla', 'interventionNames': ['Procedure: Active comparator- Entire papilla preservation technique']}], 'interventions': [{'name': 'Experimental- Nonincised papillae surgical approach', 'type': 'PROCEDURE', 'otherNames': ['NIPSA'], 'description': 'The basic principle of the technique is the placement of only one buccal horizontal or oblique incision in the mucosa, as apically as possible from the periodontal defect and the marginal tissues, and the raising of a mucoperiosteal flap coronally, which permits apical access to the defect but leaving the marginal tissues intact, acting as a "dome" for the protection of the clot.', 'armGroupLabels': ['Nonincised Papillae Surgical Approach']}, {'name': 'Active comparator- Entire papilla preservation technique', 'type': 'PROCEDURE', 'otherNames': ['EPP'], 'description': 'The entire Papilla Preservation Technique is to preserve the whole integrity of the defect- associated papilla providing a tunnel-like undermining incision. The completely preserved interdental papilla provides an intact gingival chamber to stabilize the blood clot and improve the wound healing process. To provide adequate access for debridement, EPP requires a short buccal vertical releasing incision on the buccal side of the neighboring tooth extending just beyond the mucogingival line.', 'armGroupLabels': ['Entire Papilla Preservation Technique']}]}, 'contactsLocationsModule': {'locations': [{'zip': '509002', 'city': 'Hyderabad', 'state': 'Telangana', 'status': 'RECRUITING', 'country': 'India', 'contacts': [{'name': 'R V Chandra, MDS;DNB;PhD', 'role': 'CONTACT', 'email': 'viswachandra@hotmail.com', 'phone': '9908183071'}], 'facility': 'R V Chandra', 'geoPoint': {'lat': 17.38405, 'lon': 78.45636}}], 'centralContacts': [{'name': 'R V Chandra, MDS;DNB;PhD', 'role': 'CONTACT', 'email': 'viswachandra@hotmail.com', 'phone': '9908183071'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'SVS Institute of Dental Sciences', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Dr R Viswa Chandra', 'investigatorAffiliation': 'SVS Institute of Dental Sciences'}}}}