Success of Implant Restorations After Immediate or Delayed Implant Placement With/Without Ridge Preservation
The Success of Implant Supported Restorations After Immediate Implant Placement or Delayed Implant Placement With or Without Ridge Preservation
1 other identifier
interventional
75
0 countries
N/A
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-loading in all groups.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Sep 2023
Longer than P75 for not_applicable
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 21, 2023
CompletedFirst Posted
Study publicly available on registry
August 14, 2023
CompletedStudy Start
First participant enrolled
September 1, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2028
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 1, 2029
August 14, 2023
August 1, 2023
5.3 years
July 21, 2023
August 4, 2023
Conditions
Outcome Measures
Primary Outcomes (1)
Combined success rate criteria.
This is the success criteria described by Ong et al. 2008, in combintation with predetermined scores for PES/WES as decribed in Garcia-Sanchez et al. 2021.
12 months after delivery of implant restoration.
Secondary Outcomes (25)
Pre-treatment outcome. Total Need for further bone augmentation.
At implant placement.
Pre-treatment outcome. Alveolar ridge dimensions clinically.
Immediately after dental extraction for type I, at month 2 for type II, at month 4 for type III/IV and at second stage surgery (10-12 weeks after implant placement) for all groups.
Pre-treatment outcome. Alveolar ridge dimensions radiographic:
Immediately after dental extraction for type I, at month 2 for type II, at month 4 for type III/IV and at 12 months post-loading for all groups.
Pre-treatment outcome. Periodontal phenotype
Before dental extraction.
Pre-treatment outcome. Keratinised attached gingivae before extraction.
Before dental extraction.
- +20 more secondary outcomes
Study Arms (3)
Type I dental implant placement.
EXPERIMENTALType I dental implant placement (immediately after extraction)
Type II dental implant placement.
EXPERIMENTALType II dental implant placement (6-8 weeks after extraction)
Type III/IV placement.
EXPERIMENTALType III/IV placement in socket preserved sites after 3-6 months.
Interventions
Placement of dental implant.
Placement of dental implant.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Officials
- STUDY DIRECTOR
Guillermo Pardo Zamora, Dr.
Universidad de Murcia. Associate Professor.
- PRINCIPAL INVESTIGATOR
Ruben Garcia-Sanchez, Dr.
Universidad de Murcia. Associate Professor.
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- INVESTIGATOR, OUTCOMES ASSESSOR
- Masking Details
- Investigator and outcome assessor will be blinded regarding group allocation as patients' ID and group will be anonimysed
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Dr. Ruben Garcia-Sanchez. Senior Lecturer.
Study Record Dates
First Submitted
July 21, 2023
First Posted
August 14, 2023
Study Start
September 1, 2023
Primary Completion (Estimated)
December 1, 2028
Study Completion (Estimated)
December 1, 2029
Last Updated
August 14, 2023
Record last verified: 2023-08
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, ICF, CSR
- Time Frame
- 3 months after publication and ending 5 years following article publication.
- Access Criteria
- This data will be shared with investigators whose proposed use of the data has been approved by an independent review committee identified for this purpose. The data will be shared to achieve the aims in the approved proposal.
Datasets generated during and/or analysed during the current study are/will be available upon request from Dr. Guillermo Pardo Zamora (gparza@um.es). This data will become available once the study results are published. The data available will be all of the individual participant data collected during the trial, after deidentification. This data will be available 3 months after publication and ending 5 years following article publication. This data will be shared with investigators whose proposed use of the data has been approved by an independent review committee identified for this purpose. The data will be shared to achieve the aims in the approved proposal. Proposals should be directed to Dr Guillermo Pardo Zamora (gparza@um.es). To gain access, data requestors will need to sign a data access agreement.