Ignite Creation Date:
2026-03-26 @ 3:18 PM
Ignite Modification Date:
2026-03-30 @ 4:14 AM
Study NCT ID:
NCT07417293
Status:
NOT_YET_RECRUITING
Last Update Posted:
2026-02-18
First Post:
2026-01-14
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Clinical and Patient Outcomes of 4 mm Ultra-Short vs. 8 mm Implants With Bone Augmentation in the Back Upper Jaw
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 35}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2026-02-20', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-01', 'completionDateStruct': {'date': '2029-07-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2026-02-10', 'studyFirstSubmitDate': '2026-01-14', 'studyFirstSubmitQcDate': '2026-02-10', 'lastUpdatePostDateStruct': {'date': '2026-02-18', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-02-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2028-07-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Age', 'timeFrame': 'The day of the inform consent and selection period and 7 days after the surgery', 'description': 'Elapsed time from the birthdate until the date of intervention assignment. Expressed in exact years.'}, {'measure': 'Gender', 'timeFrame': 'The day of the inform consent and selection period', 'description': 'male/female. Expressed as absolute and relative frequency.'}, {'measure': 'Smoking habit', 'timeFrame': 'The day of inform consent and selection period', 'description': 'Non-smoker, Smoker ≤ 10 cig per day or Former smoker. Expressed as absolute and relative frequencies.'}, {'measure': 'Bone density', 'timeFrame': 'The day of the surgery', 'description': 'Subjective evaluation during drilling. Type I, II, III, IV (Lekhom and Zarb, 1986). Expressed as absolute and relative frequencies.'}, {'measure': 'Full mouth plaque score', 'timeFrame': '12 months and 36 months after surgery', 'description': "Proposed by O'Leary in 1972. Expressed as relative frequency."}, {'measure': 'Full mouth bleeding score', 'timeFrame': '12 months and 36 months after surgery', 'description': 'Proposed by Ainamo and Bay in 1975. Expressed as relative frequency.'}, {'measure': 'Crown to implant ratio', 'timeFrame': '6 months after surgery', 'description': 'Relationship between the crown and the implant length. Measured in periapical radiographs. Expressed as mean and SD/median or IQR.'}, {'measure': 'Implant position', 'timeFrame': 'The day of Informed consent', 'description': '1st or 2nd molar. Expressed as absolute and relative frequency.'}, {'measure': 'Primary & secondary implant stability', 'timeFrame': 'The day of the surgery and 10 weeks after surgery', 'description': 'Based on a resonance frequency analysis (with ISQ values). Expressed as means and SD /median and IQR.'}, {'measure': 'Vertical soft tissue height', 'timeFrame': 'The day of the surgery', 'description': 'Measured with a PCP UNC 15 periodontal probe as the distance from the bone crest to the most coronal portion of keratinized tissue once the buccal flap is raised. Expressed as means and SD /median and IQR.'}], 'primaryOutcomes': [{'measure': 'Satisfaction of the surgical procedure', 'timeFrame': 'The day of the intervention after the surgery is finalized', 'description': "The patient is gonna make a subjective assessment of satisfaction of the surgery once it is finished. For that, we are going to use a 10 centimeter visual analog scale. The extremes of the scale are the extreme expressions of satisfaction, where the extreme left represents a 0 (not satisfied) and 10 (very satisfied). The patient won't have numbers between 0-10 so he will not be influenced by them. Wherever he marks, we will measure it and it will represent in centimeters how was his satisfaction"}], 'secondaryOutcomes': [{'measure': 'Surgical time', 'timeFrame': 'at the day of the intervention, since the administration of the anesthesia until the placement of the last suture knot', 'description': 'elapsed time since the administration of local anesthesia until the placement of the last suture knot, with a scale of the exact minutes'}, {'measure': 'Pain Intensity', 'timeFrame': 'Since the day of the intervention once the surgery is finalized , until the 7th day after the surgery, each day of the following 7 days', 'description': 'Subjective assessment of pain intensity using a 10-cm visual analog scale. The extremes of the scale are the extreme expressions of pain'}, {'measure': 'Rescue medication', 'timeFrame': 'After the surgery during the next 7 days', 'description': 'The need to intake rescue medication of Ibuprofen 600mg, Paracetamol 650mg or Amoxicilin 500mg with a nominal response of Yes or No'}, {'measure': 'Intra-surgical complications', 'timeFrame': 'The day of the surgery', 'description': 'Any undesired event that happens during the surgical procedure, for example, profuse bleeding, Schneider membrane perforation, by a categorical nominal answer Yes or No'}, {'measure': 'Post-surgical complications', 'timeFrame': '7 days after the surgery', 'description': 'Any undesired event that happens during the first week of healing'}, {'measure': 'Implant survival', 'timeFrame': 'From 10 weeks after surgery to 36 months, after restoration delivery', 'description': 'If the implant is present in the mouth regardless of the biological or technical complications. An implant will be considered as failed if explantation is needed for the following reasons: (i) lateral, vertical mobility or rotation; (ii) drastic decrease in the ISQ values over time; (iii) discomfort or pain; and (iv) peri-implant radiolucency compatible with fibrointegration. It will be evaluated in a categorical nominal answer Yes or No'}, {'measure': 'Marginal bone level changes', 'timeFrame': 'The day of the surgery, 12 months after and 36 months after', 'description': 'distance from the mucosal margin to the base of the peri-implant pocket as measured with a PCP UNC 15 periodontal probe. By a mm scale'}, {'measure': 'Probing pocket depth', 'timeFrame': '12 months after surgery and 36 months after surgery', 'description': 'distance from the mucosal margin to the base of the peri-implant pocket as measured with a PCP UNC 15 periodontal probe. Scale in mm.'}, {'measure': 'Bleeding on probing', 'timeFrame': '12 months and 36 months after surgery', 'description': ': presence or absence of bleeding when performing the peri-implant probing. By a categorical nominal answer Yes or No'}, {'measure': 'Suppuration on probing', 'timeFrame': '12 months and 36 months after surgery', 'description': 'Presence or absence of suppuration when performing the peri- implant probing. By a categorical nominal answer Yes or No'}, {'measure': 'Keratinized mucosa width', 'timeFrame': '12 months and 36 months after surgery', 'description': 'distance from the mucogingival line to the peri-implant mucosal margin in the buccal site as measured with a PCP UNC 15 periodontal probe. In a mm scale'}, {'measure': 'Soft tissue dehiscence', 'timeFrame': '12 months and 36 months after surgery', 'description': 'exposure of any of the abutment or implant components, by a categorical nominal answer Yes or No'}, {'measure': 'Prosthetic complications', 'timeFrame': '12 months and 36 months after surgery', 'description': 'Any undesired event in the prosthetic component (abutment or crown), for example, screw loosening, ceramic chipping'}]}, 'oversightModule': {'isUsExport': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'conditions': ['Posterior Atrophic Maxilla']}, 'descriptionModule': {'briefSummary': 'This study aims to compare 2 different groups of patients with both a healed site in the upper posterior sector after extractions, one treated with ultra-short implants, and another with long implants with bone regeneration. The objective is to evaluate if short-implants are superior in terms of better clinical outcomes, survival rates and safety, reduced surgical time, postoperative discomfort, and complication risk compared to conventional implants and bone regeneration.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "inclusion criteria:\n\n* Inform consent signed.\n* Adult patients (≥18 years old).\n* No pregnant women or without the desire to stay.\n* Periodontal and peri-implant health in a pristine or reduced periodontium.\n* Full mouth plaque score \\< 20% (O'Leary, 1972)\n* Maxillary multiple posterior maxillary healed sites at least 4 months after extraction (with antagonist teeth with a good prognosis (Lindhe et al. 2008)) presenting ≥ 6.5 mm of bone width and 5-6 mm in height from the bone crest to the floor of the sinus.\n* Need for a multiple splinted implant supported restoration with distal adjacent teeth or distal free-end in the posterior maxilla\n\nexclusion criteria\n\n* Patients with uncontrolled systemic diseases.\n* Smoker patients (≥10 cig/day).\n* Patients taking medications that affect bone metabolism or immunologic disorders.\n* Patients allergic to penicillin.\n* Patients presenting acute or chronic maxillary sinus lesions.\n* Advanced vertical crestal bone atrophy in the posterior maxilla (Type V and IV, Cawood-Howell Classification)\n* Vertical space of \\< 6 mm for a screw-retained implant restoration.\n* Patients referring allergy to titanium or to any component of the implant/restoration.\n* No previous attempts of implant installation in the same surgical site.\n* Pregnant or lactating women.\n* Patients willing to start or in course of an orthodontic therapy."}, 'identificationModule': {'nctId': 'NCT07417293', 'briefTitle': 'Clinical and Patient Outcomes of 4 mm Ultra-Short vs. 8 mm Implants With Bone Augmentation in the Back Upper Jaw', 'organization': {'class': 'OTHER', 'fullName': 'Universitat Internacional de Catalunya'}, 'officialTitle': 'Clinical- and Patient-related Outcomes of 4 mm Ultra-short Implants Compared to 8 Mm-long Implants With Bone Augmentation for the Rehabilitation of Posterior Atrophic Maxilla: a Randomized Controlled Clinical Trial.', 'orgStudyIdInfo': {'id': 'PER-ECL-2024-07'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'ultra-short implants', 'description': '4mm long implants', 'interventionNames': ['Device: Ultra short implants']}, {'type': 'OTHER', 'label': 'long implants with bone augmentation', 'description': '8mm long implants after transcrestal sinus floor elevation with bone augmentation', 'interventionNames': ['Device: Long implants with bone augmentation']}], 'interventions': [{'name': 'Ultra short implants', 'type': 'DEVICE', 'description': 'Placement of an ultra short implant of 4mm in the posterior atrophic maxilla without any bone regeneration procedure', 'armGroupLabels': ['ultra-short implants']}, {'name': 'Long implants with bone augmentation', 'type': 'DEVICE', 'description': 'Placement of long implants of 8mm in the posterior atrophic maxilla alongside bone augmentation', 'armGroupLabels': ['long implants with bone augmentation']}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Universitat Internacional de Catalunya', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}