Ignite Creation Date:
2026-03-26 @ 3:19 PM
Ignite Modification Date:
2026-03-31 @ 3:30 PM
Study NCT ID:
NCT07436533
Status:
RECRUITING
Last Update Posted:
2026-02-27
First Post:
2026-02-21
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Osseodensification for Narrow Alveolar Ridge Expansion
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': "This study follows a single-arm, prospective interventional clinical design. All enrolled participants will receive the same intervention consisting of implant site preparation using the osseodensification technique for horizontal ridge expansion in narrow mandibular alveolar ridges.\n\nThere is no control or comparison group. Each participant serves as their own control, with ridge width measurements recorded before and after osseodensification during the same surgical procedure. The intervention is performed in a standardized manner using Densah burs operating in densifying mode according to the manufacturer's protocol.\n\nDirect intraoperative measurements of alveolar ridge width will be obtained using standardized Micro Castroviejo bone calipers at two predefined levels (crestal level , at5mm and10 mm apical to the crest). The primary comparison is within-subject dimensional change (pre- versus post-osseodensification)."}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 30}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-02-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-02', 'completionDateStruct': {'date': '2026-09-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2026-02-25', 'studyFirstSubmitDate': '2026-02-21', 'studyFirstSubmitQcDate': '2026-02-21', 'lastUpdatePostDateStruct': {'date': '2026-02-27', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-02-27', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-03-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'alveolar Ridge Width Change After Osseodensification', 'timeFrame': 'Intraoperative assessment (immediately before and immediately after osseodensification during the same surgical procedure)', 'description': 'Change in alveolar ridge width (in millimeters) measured directly using standardized Micro Castroviejo bone calipers at two reference levels: (1) crestal bone level and (2) 5 mm apical to the crest(3)10 mm apical to the crest. Measurements are recorded immediately before osteotomy preparation and immediately after completion of osseodensification, prior to implant placement. The primary endpoint is the within-subject difference (post-osseodensification minus pre-osseodensification) in ridge width at both levels.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['osseodensification', 'narrow alveolar ridge', 'Densah burs', 'ridge expansion'], 'conditions': ['Osseodensification', 'Bone Expansion']}, 'descriptionModule': {'briefSummary': 'This prospective clinical study aims to evaluate the effectiveness of osseodensification in expanding narrow alveolar ridges during dental implant site preparation. Alveolar ridge deficiency is a common clinical challenge that may complicate implant placement. Osseodensification is a minimally invasive drilling technique that preserves and compacts bone rather than removing it, potentially allowing simultaneous ridge expansion and implant placement.\n\nIn this study, patients presenting with narrow alveolar ridges indicated for dental implant placement will be treated using Densah burs operating in a non-extractive (densifying) mode. Ridge width will be measured directly using standardized Micro Castroviejo bone calipers at two reference levels: at the crestal bone level and at 5mm, at 10 mm apical to the crest. Measurements will be recorded immediately before and immediately after osseodensification.\n\nThe primary objective is to assess the dimensional changes in ridge width achieved through osseodensification without the use of additional ridge augmentation procedures. The study focuses solely on within-subject comparison (pre- and post-expansion measurements) and does not compare this technique to other ridge expansion methods.\n\nThe results are expected to provide clinical evidence regarding the amount of horizontal ridge expansion achievable using osseodensification and its applicability in managing narrow alveolar ridges for implant therapy.', 'detailedDescription': 'This prospective clinical study follows a standardized protocol for alveolar ridge expansion using osseodensification. After local anesthesia and reflection of a full-thickness mucoperiosteal flap, the initial bone width is measured at the crest (0 mm) and 5 mm apical to the crest using Micro Castroviejo Bone Calipers.\n\nThe implant site preparation begins with a pilot drill, followed by the use of densifying burs (e.g., Densah Burs) in a counter-clockwise direction (non-subtractive mode) with copious irrigation. This technique allows for lateral condensation and expansion of the bone as the burs advance. After reaching the final desired diameter, the bone width is measured again at the same two levels (0 mm and 5 mm) to record the expansion gain.\n\nFinally, the dental implant is placed, and primary stability is recorded using Insertion Torque . Post-operative care and follow-up follow standard dental implant protocols'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients aged 18 years or older, including both genders.\n* Healed edentulous sites (short or long spans, single or multiple missing teeth) in maxillary or mandibular arches.\n* At least 6 months post-extraction period (delayed implant placement).\n* Alveolar ridge width of 3-5 mm at the crest (buccolingually).\n* Low-density jaw regions (D1-D5 according to Misch classification).\n* Presence of ≥ 2 mm trabecular bone core and trabecular-to-cortical bone ratio of ≥ 1:1.\n* Sufficient vertical dimensions as assessed via CBCT.\n* Straightforward cases according to SAC classification (Beagle, 2013).\n* Well-motivated patients willing to attend follow-up visits and maintain good oral hygiene.\n\nExclusion Criteria:\n\n* Acute or chronic infection or pathological condition at the proposed implant site.\n* Severe buccal plate undercut or concavity.\n* Signs of active infection in the implant zone.\n* Severe parafunctional habits such as bruxism or clenching.\n* Heavy smoking (more than 10 cigarettes per day).\n* Inadequate inter-ridge distance or insufficient vertical height for implant placement.\n* Use of medications compromising bone healing (e.g., corticosteroids, hormone replacement therapy, or bisphosphonates).\n* Uncontrolled systemic diseases (e.g., diabetes, immunocompromised states, hyperparathyroidism, or fibrous dysplasia).\n* History of radiotherapy to the head/neck or chemotherapy within the past 5 years.\n* Current pregnancy during the surgical procedure.'}, 'identificationModule': {'nctId': 'NCT07436533', 'acronym': 'OD-RridgeExp', 'briefTitle': 'Osseodensification for Narrow Alveolar Ridge Expansion', 'organization': {'class': 'OTHER', 'fullName': 'University of Science and Technology, Yemen'}, 'officialTitle': 'Expansion of Narrow Alveolar Ridge by Osseodensification A Prospective Clinical Study', 'orgStudyIdInfo': {'id': '1446/0042/UREC/UST'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'osseodensification Group', 'description': "Participants with narrow alveolar ridges indicated for dental implant placement will undergo implant site preparation using the osseodensification technique. After flap elevation, baseline ridge width measurements will be obtained at the crestal level at 5mm and 10 mm apical to the crest using standardized Micro Castroviejo bone calipers. Osteotomy preparation will then be performed using Densah burs operating in densifying mode according to the manufacturer's recommended protocol. Following completion of osteotomy preparation and prior to implant insertion, ridge width measurements will be repeated at the same reference points. The primary evaluation consists of within-subject comparison of pre- and post-osseodensification ridge width measurements.", 'interventionNames': ['Procedure: Densah burs (Osseodensification Technique)']}], 'interventions': [{'name': 'Densah burs (Osseodensification Technique)', 'type': 'PROCEDURE', 'otherNames': ['Densifying osteotomy preparation', 'Compaction drilling technique', 'Non-extractive drilling protocol', 'Osseodensification drilling protocol'], 'description': 'Implant site preparation using Densah burs in counterclockwise (densifying) mode to achieve bone compaction and horizontal ridge expansion without additional grafting procedures', 'armGroupLabels': ['osseodensification Group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '(15201 - 13064)', 'city': 'Sanaa', 'state': 'S', 'status': 'RECRUITING', 'country': 'Yemen', 'contacts': [{'name': 'Essam Ali AL-saidi, BDS', 'role': 'CONTACT', 'email': 'asdentme@gmail.com', 'phone': '00967 770982890'}], 'facility': '60 Meters St., Madbah, University of Science and Technology', 'geoPoint': {'lat': 15.35452, 'lon': 44.20646}}], 'centralContacts': [{'name': 'Essam Ali AL-saidi, BDS', 'role': 'CONTACT', 'email': 'asdentme@gmail.com', 'phone': '00967 770982890 - 00967 771699'}, {'name': 'Abdalwahab Yahya Aldailami, PhD', 'role': 'CONTACT', 'phone': '00967 777781033'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Science and Technology, Yemen', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': "Master's Degree Candidate, F aculty of Dentistry", 'investigatorFullName': 'Essamali Alsaidi', 'investigatorAffiliation': 'University of Science and Technology, Yemen'}}}}