Peri-implant Soft Tissue and Bone Evaluation in Fully Computer Guided Immediate Implants
NCT ID: NCT06733870
Last Updated: 2024-12-13
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
NA
16 participants
INTERVENTIONAL
2023-10-11
2024-12-20
Brief Summary
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Detailed Description
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The study will be conducted on total of 16 patients recruited from the outpatient clinic of Oral Medicine, Periodontology, Oral Diagnosis and Radiology department, Faculty of Dentistry, Ain-Shams University. Sixteen consecutive healthy male/female patients with single non restorable remaining maxillary root from the right second premolar to the left second premolar will be added to the study.
Sample size analysis :
A sample size of 14 (7 in each group) will be sufficient to detect an effect size of approximately 1.75, with a power (1-β error) of 0.8 (80%) using a two-sided hypothesis test, with a significance level (α error) 0.05 for data. G power program version 3.1.9.2 was used for sample size calculation.This was increased to 8 patients in each group to make up for lost follow up cases The procedure will be explained to all patients and an informed consent will be signed before their inclusion in the study.
These patients will be divided randomly into 2 groups:
Group I: will include 8 patients who will undergo guided immediate implant placement and immediate provisionalization with preplanned PMMA provisional restoration on Ti-Base Group II: will include 8 patients who will undergo guided immediate implant placement and immediate loading by using a final CAD/CAM customized abutment and a cemented CAD/CAM fabricated PMMA provisional restoration.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
OTHER
DOUBLE
Study Groups
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immediate load with provisional restoration
immediate load with PMMA crown on Ti base
guided immediate implant surgery
fully guided immediate implant placement and loading
immediate load with one abutment one time concept
immediate ;load with customized final abutment and PMMA crown
guided immediate implant surgery
fully guided immediate implant placement and loading
Interventions
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guided immediate implant surgery
fully guided immediate implant placement and loading
Eligibility Criteria
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Inclusion Criteria
* Patients free from any systemic disease as evidenced by health questionnaire - - Single tooth failure of a maxillary anterior region (incisors, canines, and premolars) with neighbouring teeth present and healthy periodontal conditions.
* Intact socket walls evident on cone beam computed tomography and confirmed on the day of extraction.
* Natural teeth present adjacent to the tooth being replaced in addition to a natural counterpart tooth present for esthetics criteria evaluation.
* Adequate bone apical to the tooth to be replaced with a minimum primary stability of 30 Ncm.
* Thick gingival biotype.
Exclusion Criteria
* Presence of active periodontal disease and gingival recession in the esthetic area.
* Systemic diseases , pregnancy and smoking.
* Recent orthodontic treatment.
* Bruxism and parafunctional habits .
* Labial plate dehiscence, fenestration, or loss after tooth extraction
* Inability to achieve primary stability after implant placement
* Vulnerable groups: prisoners, mentally retarded, etc
18 Years
ALL
Yes
Sponsors
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Ain Shams University
OTHER
Responsible Party
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Nouran Abd El Nasser
Assistant lecturer
Principal Investigators
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Mohamed Bissar, Associate professor
Role: STUDY_DIRECTOR
Faculty of dentistry- Ain Shams University
Ingy Nouh, lecturer
Role: STUDY_DIRECTOR
Faculty of dentistry- Ain Shams University
Hala Kamal, Professor
Role: STUDY_DIRECTOR
Faculty of dentistry- Ain Shams University
Locations
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faculty of Dentistry ASU
Cairo, , Egypt
Countries
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Other Identifiers
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FDASU.REC ID 032124
Identifier Type: -
Identifier Source: org_study_id