Status:
NOT_YET_RECRUITING
Success of Implant Restorations After Immediate or Delayed Implant Placement With/Without Ridge Preservation
Lead Sponsor:
Hospital General Universitario Morales Meseguer
Conditions:
Dental Implant
Eligibility:
All Genders
23+ years
Phase:
NA
Brief Summary
The study aims to compare clinical, radiographic, patient-reported outcomes (PROMs) and cost analysis outcomes in type I, II and socket preserved sites (III/IV) implant placement at 1-year post-loadin...
Detailed Description
This is a prospective, parallel-group, randomized study aiming to compare clinical, radiographic, PROMS and health-economic outcomes of type I, type II and type III/IV (in socket preserved areas) impl...
Eligibility Criteria
Inclusion
- i) Patient must have willingness to read and sign a copy of the Informed Consent Form Males and females, ≥23 years old.
- ii) Patient in need of a single permanent tooth extraction with clinical and/or radiographic evidence of unrestorable maxillary premolars, canines, or incisors with at least one adjacent tooth present, and with periodontal attachment preserved at least for two thirds of the root not associated with acute periapical pathology.
- iii) Post-extraction alveolar bone defect with ≤50 % buccal bone loss. This will be confirmed at Visit 2 after extraction. In case of \>50% buccal bone loss, the participant will be withdrawn from the study.
- iv) Patient in good general health as documented by self-assessment. v) Full mouth bleeding and plaque scores (FMBS \<10% and FMPS \<30%) recorded within the previous 8 weeks.
Exclusion
- i) Uncontrolled or untreated periodontal disease. ii) History of local (head and neck) radiation therapy. iii) Presence of oral lesions in the area of the extraction (such as ulceration, malignancy).
- iv) Severe bruxing or clenching habits. v) Acute endodontic lesion in the test tooth or in the neighbouring areas to the extraction procedure (sites with presence of an asymptomatic chronic lesion are eligible).
- vi) Medical history that includes uncontrolled diabetes or hepatic or renal disease, or other serious medical conditions that can impact on bone metabolism (e.g. rheumatoid arthritis, osteoporosis) or transmittable diseases (e.g. AIDS).
- vii) History of alcohol or drug abuse. viii) Smokers. ix) Self-reported pregnancy or lactation (this criterion is due to oral tissue changes related to pregnancy and nursing which can affect interpretation of study results).
- x) Other severe acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with trial participation or investigational product administration or may interfere with the interpretation of trial results and, in the judgement of the investigator, would make the subject inappropriate for entry into this trial.
- xi) Malocclusion, or collapse of the occlusal vertical dimension leading to dentoalveolar compensation which could interfere with ridge preservation dimensions and measurements.
- xii) Lack of adjacent sound restored or unrestored teeth.
Key Trial Info
Start Date :
September 1 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2029
Estimated Enrollment :
75 Patients enrolled
Trial Details
Trial ID
NCT05988281
Start Date
September 1 2023
End Date
December 1 2029
Last Update
August 14 2023
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