Study Results
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View full resultsBasic Information
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COMPLETED
NA
30 participants
INTERVENTIONAL
2017-07-01
2024-11-01
Brief Summary
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Detailed Description
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Each patient will be randomly allocated in one of the two groups: test group (n=36) or control group (n=12) and all the implants will be placed by residents of the International Master in Oral Surgery and Master in Periodontics of the same University.
Study groups
Group 1: Two stage approach (cover screw in first surgery and healing abutment in second surgery) (12 patients)
Group 2: One stage approach (healing cap over trans-epithelial abutments) (36 patients).Two subgroups according to different trans-epithelial height abutment:
* Subgroup 2.1: Screw-retained abutment of 1 mm height (18 patients)
* Subgroup 2.2: Screw-retained abutment of 2.5 mm height (18 patients)
Clinical Parameters and Outcomes
* Three-dimensional volumetric changes in hard and soft tissues (Cone-beam computed tomography superposed with digital cast models).
* Marginal bone level (MBL) change: Standardized intraoral periapical x-rays will be taken on the day of surgery, 4, 6, 12, 24 and 36 months following surgery.
* Probing depth, bleeding on probing and keratinized mucosa width will be measured in the follow-up visits in 3 different points in buccal (Mesial, center and distal).
* VAS Scale: The visual analog scale or visual analog scale (VAS).
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Control group
Group 1: 2 stage approach (cover screw) (12 patients): cover screw is placed over the dental implants in the first surgery and a second surgery will be performed to expose the implants and placing a healing abutment after 2-4 months, DEVICES: COVER SCREW (first surgery) and HEALING ABUTMENT (second surgery)
Dental implant placement with COVER SCREW (two surgeries in control group) or DEFINITIVE TRANSEPITHELIAL ABUTMENT (one surgery in test group)
Dental implant placement using cover screws (first surgery) and a healing abutment (second surgery) or definitive transepithelial abutments the same day of the implant placement (one unit surgery)
Test group
Group 2: Protective plastic cap over different definitive trans-epithelial abutments are placed in the unic surgery performed (36 patients): Definitive transepithelial abutments will be placed the same day of the implant placement surgery. DEVICE: DEFINITIVE TRANSEPITHELIAL ABUTMENT
Dental implant placement with COVER SCREW (two surgeries in control group) or DEFINITIVE TRANSEPITHELIAL ABUTMENT (one surgery in test group)
Dental implant placement using cover screws (first surgery) and a healing abutment (second surgery) or definitive transepithelial abutments the same day of the implant placement (one unit surgery)
Interventions
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Dental implant placement with COVER SCREW (two surgeries in control group) or DEFINITIVE TRANSEPITHELIAL ABUTMENT (one surgery in test group)
Dental implant placement using cover screws (first surgery) and a healing abutment (second surgery) or definitive transepithelial abutments the same day of the implant placement (one unit surgery)
Eligibility Criteria
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Inclusion Criteria
2. Overall, healthy subjects
3. Females and males of at least eighteen-years
4. Requiring a minimum of two implants (molar and/or premolar teeth)
5. Adequate oral hygiene (less than 15% FMPS)
6. Able to follow instructions and attend a regular compliance
7. Enough bone to place a standard implant of 4.1 mm diameter.
Exclusion Criteria
2. Occlusal overload with parafunctional activity (assessed clinically)
3. Large occlusal discrepancies
4. Untreated periodontal disease assessed by Socransky et al. parameters (≥2mm clinical attachment loss in two consecutive visits within 1 year)
5. Smokers (more than 10 cigarettes/day)
6. Drug and/or alcoholic dependencies
7. Medical conditions contraindicating implant surgery
8. History of head and/or neck radiation
9. Bisphosphonate therapy
18 Years
ALL
Yes
Sponsors
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Universitat Internacional de Catalunya
OTHER
Responsible Party
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Jordi Gargallo-Albiol
Associate Professor of Oral and Maxillofacial Surgery
Principal Investigators
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Jordi Gargallo-Albiol
Role: PRINCIPAL_INVESTIGATOR
Universitat Internacional de Catalunya
Locations
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Universitat Internacional de Catalunya
Barcelona, , Spain
Countries
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Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Document Type: Informed Consent Form
Other Identifiers
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CIR-ECL-2016-03
Identifier Type: -
Identifier Source: org_study_id
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