Ignite Creation Date:
2025-12-25 @ 12:38 AM
Ignite Modification Date:
2025-12-25 @ 10:47 PM
Study NCT ID:
NCT05005767
Status:
UNKNOWN
Last Update Posted:
2021-08-16
First Post:
2021-07-31
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Effect of Frankincense Extract Gel on Non-Surgical Treatment of Chronic Periodontitis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D055113', 'term': 'Chronic Periodontitis'}], 'ancestors': [{'id': 'D010518', 'term': 'Periodontitis'}, {'id': 'D010510', 'term': 'Periodontal Diseases'}, {'id': 'D009059', 'term': 'Mouth Diseases'}, {'id': 'D009057', 'term': 'Stomatognathic Diseases'}, {'id': 'D002908', 'term': 'Chronic Disease'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D014080', 'term': 'Tooth Exfoliation'}, {'id': 'D016745', 'term': 'Root Planing'}], 'ancestors': [{'id': 'D009063', 'term': 'Dental Physiological Phenomena'}, {'id': 'D055688', 'term': 'Digestive System and Oral Physiological Phenomena'}, {'id': 'D012534', 'term': 'Dental Scaling'}, {'id': 'D003777', 'term': 'Dental Prophylaxis'}, {'id': 'D010517', 'term': 'Periodontics'}, {'id': 'D003813', 'term': 'Dentistry'}, {'id': 'D013357', 'term': 'Subgingival Curettage'}, {'id': 'D011313', 'term': 'Preventive Dentistry'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'twenty patients will be randomly be selected and equally divided into Group I: will receive SRP only, group II: will receive SRP and Frankincense extract the gel. Subgingival application of Frankincense extract gel will be performed following initial SRP )day 1) and at 7, and 14 days.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 20}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2021-04-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-08', 'completionDateStruct': {'date': '2022-03', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2021-08-10', 'studyFirstSubmitDate': '2021-07-31', 'studyFirstSubmitQcDate': '2021-08-10', 'lastUpdatePostDateStruct': {'date': '2021-08-16', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-08-16', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-11', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'probing pocket depth', 'timeFrame': 'baseline', 'description': 'probing pocket depth will be recorded at baseline, at site that will be treated'}, {'measure': 'probing pocket depth', 'timeFrame': '1 month', 'description': 'probing pocket depth will be recorded at 1 month at the site to be treated'}, {'measure': 'probing pocket depth', 'timeFrame': '3 month', 'description': 'probing pocket depth will be recorded at 3 month at the site to be treated'}, {'measure': 'clinical attachment level', 'timeFrame': 'baseline', 'description': 'clinical attachment level will be recorded at baseline,'}, {'measure': 'clinical attachment level', 'timeFrame': '1 month', 'description': 'clinical attachment level will be recorded at , 1 month at the site to be treated'}, {'measure': 'clinical attachment level', 'timeFrame': '3 month', 'description': 'clinical attachment level will be recorded at 3 months at the site to be treated'}, {'measure': 'bleeding on probing', 'timeFrame': 'baseline', 'description': 'bleeding on probingwill be recorded at baseline, at the site to be treated'}, {'measure': 'bleeding on probing', 'timeFrame': '1 month', 'description': 'bleeding on probingwill be recorded at 1, month at the site to be treated'}, {'measure': 'bleeding on probing', 'timeFrame': '3 month', 'description': 'bleeding on probingwill be recorded at 3 months at the site to be treated'}, {'measure': 'PCR for Porphyromonas gingivalis count', 'timeFrame': 'baseline', 'description': 'PCR for Porphyromonas gingivalis count be recorded at baseline, at the site to be treated'}, {'measure': 'PCR for Porphyromonas gingivalis count', 'timeFrame': '1 month', 'description': 'PCR for Porphyromonas gingivalis count be recorded at 1, and month at the site to be treated'}, {'measure': 'PCR for Porphyromonas gingivalis count', 'timeFrame': '3 month', 'description': 'PCR for Porphyromonas gingivalis count be recorded at 3 months at the site to be treated'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['chronic periodontitis.', 'Frankincense', 'non surgical treatment'], 'conditions': ['Chronic Periodontitis']}, 'descriptionModule': {'briefSummary': 'This study will evaluate the effect of the subgingival application of Frankincense extract gel as an adjunct to scaling and root planning (SRP) in chronic periodontitis.', 'detailedDescription': ': twenty patients will be randomly selected and equally divided into Group I: will receive SRP only, group II: will receive SRP and Frankincense extract the gel. Subgingival application of Frankincense extract gel will be performed following initial SRP )day 1) and at 7, and 14 days. Clinical measurements included pocket depth (PD), bleeding on probing (BOP), and clinical attachment level (CAL). Real-time PCR was carried out to determine the effect of the treatment on Porphyromonas gingivalis (Pg). Clinical measurements and Plaque samples for PCR were recorded at baseline (before treatment), one, and three months after treatment.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '30 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* systemically healthy patients were selected\n* patients who had not received any medications for the previous six months that may interfere with periodontal tissue health or healing.\n* Patients should demonstrate their ability to maintain good oral hygiene\n\nExclusion Criteria:\n\n* Smokers and pregnant patients.\n* Medically compromised patients and systemic conditions precluding periodontal surgery.'}, 'identificationModule': {'nctId': 'NCT05005767', 'briefTitle': 'Effect of Frankincense Extract Gel on Non-Surgical Treatment of Chronic Periodontitis', 'organization': {'class': 'OTHER', 'fullName': 'Tanta University'}, 'officialTitle': 'The Adjunctive Effect of Frankincense Extract Gel on Non-Surgical Treatment of Chronic Periodontitis: Clinical and Microbiological Study.', 'orgStudyIdInfo': {'id': '2D'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo group', 'description': 'ten patients with sites suffering from mild chronic periodontitis sites will be treated with scaling and root planing (SRP) only', 'interventionNames': ['Procedure: scaling and root planing']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'test group', 'description': 'Ten patients with sites suffering from mild chronic periodontitis. sites will be treated with scaling and root planing (SRP) and subgingival application of Frankincense extract gel', 'interventionNames': ['Procedure: scaling and root planing', 'Procedure: Frankincense extract gel natural herbal product']}], 'interventions': [{'name': 'scaling and root planing', 'type': 'PROCEDURE', 'description': 'will receive scaling and root planing only', 'armGroupLabels': ['Placebo group', 'test group']}, {'name': 'Frankincense extract gel natural herbal product', 'type': 'PROCEDURE', 'otherNames': ['Scaling and root planing'], 'description': 'will receive Scaling and root planing then. Subgingival application of Frankincense extract gel', 'armGroupLabels': ['test group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '31511', 'city': 'Tanta', 'state': 'Gharbia Governorate', 'country': 'Egypt', 'facility': 'Doaa Ahmed yousef bayoumi', 'geoPoint': {'lat': 30.78847, 'lon': 31.00192}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Tanta University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'lecturer at Periodontology, oral medicine, diagnosis and radiology department', 'investigatorFullName': 'Doaa Ahmed Yousef', 'investigatorAffiliation': 'Tanta University'}}}}