Ignite Creation Date:
2025-12-24 @ 10:29 PM
Ignite Modification Date:
2026-01-01 @ 5:57 PM
Study NCT ID:
NCT05898035
Status:
RECRUITING
Last Update Posted:
2025-04-08
First Post:
2023-03-02
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Postoperative Symptoms Following Endodontic Microsurgery
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010149', 'term': 'Pain, Postoperative'}, {'id': 'D019066', 'term': 'Facies'}, {'id': 'D010146', 'term': 'Pain'}], 'ancestors': [{'id': 'D011183', 'term': 'Postoperative Complications'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D020969', 'term': 'Disease Attributes'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'This a randomized prospective clinical study'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 40}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2022-02-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-04', 'completionDateStruct': {'date': '2025-09', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-04-04', 'studyFirstSubmitDate': '2023-03-02', 'studyFirstSubmitQcDate': '2023-06-07', 'lastUpdatePostDateStruct': {'date': '2025-04-08', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-06-12', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-12-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'changes in pain severity', 'timeFrame': 'to measure changes in the pain severity at 3 hours, 24 hours , 48 hours , 72 hours and 120 hours.', 'description': 'visual analogue scale that is calibrated between (no discomfort ) and end with (very server pain ),'}, {'measure': 'Swelling size changes', 'timeFrame': 'At the second and seventh days after the microsurgery, patients will be re-called for the determination of edema and swelling', 'description': 'Changes in amount of swelling will be measured by measuring distance between fixed points in patient face.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Microsurgery, Pain, swelling, Piezo surgery'], 'conditions': ['Pain Postoperative', 'Swelling Lips & Face']}, 'descriptionModule': {'briefSummary': 'Aims: The purpose of this randomized clinical trial is to assess and compare the post operative pain, swelling and quality of life after endodontic microsurgery using either conventional osteotomy or piezoelectric osteotomy . The PICO question that will be used is Does endodontic microsurgery using piezoelectric osteotomy have similar clinical performance in terms of post operative pain and swelling to that of endodontic microsurgery using conventional hand-piece osteotomy.\n\nMaterial and methods:\n\nbased on solid inclusion criteria , a total of 44 patients in need of endodontic microsurgery will be randomly distributed into two groups (n=22) according to the osteotomy technique: conventional and piezoelectric osteotomy. A standardized microsurgical technique will be employed. After the microsurgery procedure, a pain questionnaire that contain visual analogue scale will be given to each patient to evaluate the pain incidence and intensity at 5 time intervals, 24 hours, 48 hours, 72 hours, 96 hours and 120 hours. The patients will be recalled as well, at days 2 and 7 to evaluate the swelling. Statistical analysis will be performed using chi-square test and linear regression analysis.', 'detailedDescription': 'This randomized prospective clinical study will be conducted at the postgraduate clinics, Department of Conservative Dentistry, at Jordan University of Science and Technology.\n\nEthical approval will be sought from the JUST Institutional ethics and human Research Board (IRB) committee.\n\nSample size and randomization A total of 44 adult patients will be recruited for this clinical trial. Participants will be randomly allocated to one of the two treatment modalities. Randomization will be carried out by sealed envelope online software.\n\nFor the observational part of the study, no randomization or blinding will be applied. Patients will be treated free of charge and their travel expenses will be compensated for all follow up visits.\n\nPreoperative management :\n\nClinical and radiographic assessment :\n\n\\- The patient demographic information, chief complaint and history of the chief complaint, medical and dental history will be registered. A thorough extra-oral and intra-oral examination will be undertaken (an existing swelling , sinus tracts, quality of coronal restoration margins and its history, occlusal relations, gingival biotype , any gingival recession and periodontal assessment ) will be registered .\n\nPercussion and palpating tests will be applied. Pre-operative parallel Digital view will be obtained using film holder showing the entire lesion and at least 2 mm beyond it. Limited view cone beam computed tomography scan of the diseased tooth will be obtained for each patient preoperatively (SFV).\n\nRoot length and axis, Lesion size and features, bone crest level and any radiographic abnormality will be interpreted and registered.\n\nAll patients will receive periodontal scaling a week or two before the surgery. Surgical procedure Prior to surgery , patients will be asked to rinse their mouth with chlorhexidine 0.12% . After which, local anesthesia containing epinephrine will be given. The surgical flap design and procedure will be selected as per case deem , and the flap will be elevated gently and retracted.\n\nThe Root apex will be located and osteotomy will be applied. The resected root will be rinsed , dried and and stained with 1% methylene blue dye after which , it will be inspected carefully under high magnification, to identify possible reasons for the non surgical root canal treatment failure. Subsequently, ultrasonic apical preparation will be performed. After achieving adequate haemostasis with Epinephrine pellets (Gingi-Pak , California state , USA),Biodentine retrograde filling material will be placed. The flap will be re-approximated and interrupted suture using non-absorbable monofilament size 5-0 suture will be applied. Finally, Post-operative parallel Digital view will be obtained using film holder showing the entire lesion and at least 2 mm beyond it.\n\nPost-operative management :\n\nImmediately after the microsurgery the patients will be asked to apply cold ice packs on the surgical site for 20 mins at the clinic, during this time the post-operative instructions will be given .'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Non-smokers .\n* Teeth that are periodontally healthy.\n* Age (18-65)\n\nExclusion Criteria:\n\n* Patients with an active systematic diseases that may affect the outcome\n* Medically compromised patients on long term medications.\n* Patients who had received analgesics or antibiotics prior to surgery will be postponed.\n* Cases where orthograde endodontic treatment is feasible\n* Teeth with poor prognosis.\n* Teeth with an active periodontal disease (pocket depth \\> 5 mm).\n* Emotionally distressed patients.'}, 'identificationModule': {'nctId': 'NCT05898035', 'briefTitle': 'Postoperative Symptoms Following Endodontic Microsurgery', 'organization': {'class': 'OTHER', 'fullName': 'King Abdullah University Hospital'}, 'officialTitle': 'Postoperative Symptoms Following Endodontic Microsurgery Performed by Piezoelectric Osteotomy Versus Conventional Osteotomy: A Randomized Clinical Trial', 'orgStudyIdInfo': {'id': 'KingAbdullahUH'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Piezo endodontic surgery', 'description': 'The osteotomy will be applied under magnification with a surgical operating microscope (at the apical third of the root .Osteotomy will be done with the Piezosurgery touch', 'interventionNames': ['Procedure: Endodontic Microsurgery']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Conventional endodontic surgery', 'description': 'The osteotomy will be applied under magnification with a surgical operating microscope at the apical third of the root .Osteotomy will be done with air motor high speed hand-piece and round bur with copious irrigation', 'interventionNames': ['Procedure: Endodontic Microsurgery']}], 'interventions': [{'name': 'Endodontic Microsurgery', 'type': 'PROCEDURE', 'description': 'Osteotomy will be done either with air motor high speed hand-piece and round bur with copious irrigation or with Piezosurgery touch. After the soft tissue curettage and uncovering the root apex , the last 3 mm of the root apex will be resected perpendicular to the long axis of the tooth at ( 0 - 10) degree bevel , using either conventional dental hand-piece or piezotome (Piezotome Cube by ACTEON ).The resected root will be rinsed , dried and and stained with 1% methylene blue dye after which , it will be inspected carefully under high magnification, to identify possible reasons for the non surgical root canal treatment failure. Subsequently, ultrasonic apical preparation will be performed. After achieving adequate haemostasis with Epinephrine pellets. Biodentine®retrograde filling material will be placed. The flap will be re-approximated and interrupted suture using non-absorbable monofilament size 5-0 suture will be applied. Finally, Post-operative parallel Digital view.', 'armGroupLabels': ['Conventional endodontic surgery', 'Piezo endodontic surgery']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'POBOX 3030', 'city': 'Irbid', 'status': 'RECRUITING', 'country': 'Jordan', 'contacts': [{'name': 'Lama A Awawdeh', 'role': 'CONTACT', 'email': 'lawawdeh@hotmail.com', 'phone': '0795412954'}], 'facility': 'Jordan University of Science and Technology', 'geoPoint': {'lat': 32.55556, 'lon': 35.85}}], 'centralContacts': [{'name': 'Lama A Awawdeh, PhD', 'role': 'CONTACT', 'email': 'lawawdeh@hotmail.com', 'phone': '+962795412954'}], 'overallOfficials': [{'name': 'Lama A Awawdeh, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Jordan University of Science and Technolgoy'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'King Abdullah University Hospital', 'class': 'OTHER'}, 'collaborators': [{'name': 'Jordan University of Science and Technology', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Lama Awawdeh', 'investigatorAffiliation': 'King Abdullah University Hospital'}}}}