Ignite Creation Date:
2025-12-24 @ 6:38 PM
Ignite Modification Date:
2026-06-16 @ 4:07 PM
Study NCT ID:
NCT02170857
Status:
COMPLETED
Last Update Posted:
2017-07-27
First Post:
2014-06-20
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effect of Hyaluronic Acid in the Treatment of Periodontal Pockets
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': 'D006820', 'term': 'Hyaluronic Acid'}], 'ancestors': [{'id': 'D006025', 'term': 'Glycosaminoglycans'}, {'id': 'D011134', 'term': 'Polysaccharides'}, {'id': 'D002241', 'term': 'Carbohydrates'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 30}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-07', 'completionDateStruct': {'date': '2017-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-07-26', 'studyFirstSubmitDate': '2014-06-20', 'studyFirstSubmitQcDate': '2014-06-20', 'lastUpdatePostDateStruct': {'date': '2017-07-27', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2014-06-23', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in the Clinical Attachment Loss (CAL)', 'timeFrame': 'CAL will be measured at four times in this study: one week before surgical treatment, 3 months post-surgery, six months post-surgery and 12 months post-surgery', 'description': 'Clinical Attachment Loss (CAL): it is the distance between the cement-enamel junction of the tooth and the bottom of the pocket.\n\nCAL will be performed using a dental probe.'}, {'measure': 'Vertical bone fill', 'timeFrame': 'at 12 months post-surgery', 'description': 'Vertical bone fill: it is the distance between the base of the infra-bony defect and cement-enamel junction before surgery minus the distance between base of the infra-bony defect and cement enamel junction after surgery.\n\nIt will be measured on CBCT images.'}], 'secondaryOutcomes': [{'measure': 'Change in the Pocket Probing Depth (PPD)', 'timeFrame': 'PPD will be measured at four times in this study: one week before surgical treatment, 3 months post-surgery, six months post-surgery and 12 months post-surgery', 'description': 'Pocket Probing Depth (PPD): it is the distance from the gingival margin to the bottom of the pocket at four sites per tooth. PPD will be measured using a dental probe.'}, {'measure': 'Buccolingual distance', 'timeFrame': 'at 12 months post-surgery', 'description': 'Buccolingual distance: is the distance between buccal wall and lingual wall of the infra-bony pocket.'}, {'measure': 'Mesiodistal distance', 'timeFrame': 'at 12 months post-surgery', 'description': 'Mesiodistal distance: is the distance between mesial wall and distal wall of the infra-bony pocket.'}, {'measure': 'Depth of infra-bony defect', 'timeFrame': 'at 12 months post-surgery', 'description': 'Depth of infra-bony defect: is the distance between the base of the infra-bony defect and the most coronal level of alveolar crest.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Hyaluronic acid', 'infra-bony defects', 'chronic periodontitis', 'experimental', 'radiographic', 'clinical', 'periodontal surgical treatment', 'open flap curettage'], 'conditions': ['Chronic Periodontitis With Infra-bony Defects']}, 'referencesModule': {'references': [{'pmid': '22238698', 'type': 'BACKGROUND', 'citation': 'Baldini A, Zaffe D, Nicolini G. Bone-defects healing by high-molecular hyaluronic acid: preliminary results. Ann Stomatol (Roma). 2010 Jan;1(1):2-7. Epub 2010 Jun 29.'}, {'pmid': '19277251', 'type': 'BACKGROUND', 'citation': 'Ballini A, Cantore S, Capodiferro S, Grassi FR. Esterified hyaluronic acid and autologous bone in the surgical correction of the infra-bone defects. Int J Med Sci. 2009;6(2):65-71. doi: 10.7150/ijms.6.65. Epub 2009 Feb 26.'}, {'pmid': '21187628', 'type': 'BACKGROUND', 'citation': 'Bansal J, Kedige SD, Anand S. Hyaluronic acid: a promising mediator for periodontal regeneration. Indian J Dent Res. 2010 Oct-Dec;21(4):575-8. doi: 10.4103/0970-9290.74232.'}, {'pmid': '23444204', 'type': 'BACKGROUND', 'citation': 'Briguglio F, Briguglio E, Briguglio R, Cafiero C, Isola G. Treatment of infrabony periodontal defects using a resorbable biopolymer of hyaluronic acid: a randomized clinical trial. Quintessence Int. 2013 Mar;44(3):231-40. doi: 10.3290/j.qi.a29054.'}, {'pmid': '19537471', 'type': 'BACKGROUND', 'citation': 'Vanden Bogaerde L. Treatment of infrabony periodontal defects with esterified hyaluronic acid: clinical report of 19 consecutive lesions. Int J Periodontics Restorative Dent. 2009 Jun;29(3):315-23.'}, {'pmid': '23055583', 'type': 'BACKGROUND', 'citation': 'Gontiya G, Galgali SR. Effect of hyaluronan on periodontitis: A clinical and histological study. J Indian Soc Periodontol. 2012 Apr;16(2):184-92. doi: 10.4103/0972-124X.99260.'}]}, 'descriptionModule': {'briefSummary': 'The aim of this study is to evaluate the effect of hyaluronic acid in the surgical treatment of periodontal pockets in people with gum disease.\n\nThis research consists of clinical and radiographic studies. Participants should have symmetric periodontal pockets in the upper or lower jaw.\n\nParticipants will be treated surgically using hyaluronic acid on one side of the jaw.\n\nClinical indexes and radiographic cone-beam computed tomographic (CBCT) images will be taken for each participant before surgical treatment and 12 months after surgical treatment.', 'detailedDescription': 'The aim of this study is to evaluate the effect of hyaluronic acid in the surgical treatment of infra-bony pockets in chronic periodontitis patients.\n\nThis research consists of clinical and radiographic studies.\n\n1- The clinical study: is a randomized controlled trial with a split mouth technique.\n\nChronic periodontitis patients with Infra-bony pockets will be collected from the Department of Periodontics in faculty of dentistry - Damascus university.\n\nParticipants should have symmetric infra-bony pockets in the upper or lower premolar area with pocket probing depth more than 6 mm.\n\nParticipants will be treated surgically using open flap curettage.\n\nOpen flap curettage will be done for each patient in both sides of the jaw, but hyaluronic acid will be used in one of the two sides with random allocation of the site that in going to be treated with hyaluronic acid.\n\nPlaque index, gingival index, bleeding on probing, tooth mobility index, pocket probing depth and clinical attachment loss will be taken for each participant four times; before surgical treatment, 3 months, six months and 12 months after surgical treatment.\n\nRadiographic study: will be done using CBCT radiography technique. CBCT will be taken for each participant before and after 12 months of surgical treatment. Different distances, vertical bone fill and depth of infra-bony defect will be measured on CBCT images.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '35 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients with chronic periodontitis\n* Symmetric Infra-bony defects with periodontal pocket depth more than 6 mm.\n* in upper or lower premolar area.\n* All participants will be collected from patients attending department of Periodontology - faculty of dentistry for periodontal disease treatment.\n* Males and females.\n* 35-65 years old.\n* Systematically healthy.\n* Accepting to participate in the study. Informed written consent will be required.\n\nExclusion Criteria:\n\n* A history of previous scaling and root planning in the last 6 months\n* Smokers\n* Pregnant women\n* Diabetes mellitus'}, 'identificationModule': {'nctId': 'NCT02170857', 'briefTitle': 'Effect of Hyaluronic Acid in the Treatment of Periodontal Pockets', 'organization': {'class': 'OTHER', 'fullName': 'Damascus University'}, 'officialTitle': 'A Randomized Controlled Trial to Evaluate the Effect of Hyaluronic Acid on Infra-bony Defects: A Radiographic and Clinical Study.', 'orgStudyIdInfo': {'id': 'UDDS-Perio-05-2014'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'NO_INTERVENTION', 'label': 'Open Curettage Only', 'description': 'patients will be treated by the conventional surgical method, i.e. open curettage without injecting any material.'}, {'type': 'EXPERIMENTAL', 'label': 'Open Curettage with Hyaluronic Acid', 'description': 'Hyaluronic Acid injection will be employed in conjunction with the ordinary surgical procedure.', 'interventionNames': ['Drug: Hyaluronic Acid']}], 'interventions': [{'name': 'Hyaluronic Acid', 'type': 'DRUG', 'description': 'This material will be used in conjunction with the ordinary surgical procedure', 'armGroupLabels': ['Open Curettage with Hyaluronic Acid']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'DM20AM18', 'city': 'Damascus', 'country': 'Syria', 'facility': 'Department of Periodontics, University of Damascus Dental School', 'geoPoint': {'lat': 33.5102, 'lon': 36.29128}}], 'overallOfficials': [{'name': 'Lina Bashour, DDS MSc', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'PhD student, Department of Periodontics, University of Damascus Dental School, Damascus'}, {'name': 'Razan Khattab, DDS MSc PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Professor of Periodontics, Dean of the Dental School, University of Damascus Dental School, Damascus'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Damascus University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}