Evaluation of MBL Around Implants Placed in Crestal or Subcrestal Positions: a RCT

Study Overview
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Brief Summary
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The objective of this randomized controlled trial is to evaluate changes in marginal bone levels and soft tissue dimensions around implants placed with the IAI at different positions in relation to the alveolar crest

Detailed Description
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The objective of this randomized controlled trial is to evaluate changes in marginal bone levels and soft tissue dimensions around implants placed with the IAI at different positions in relation to the alveolar crest. Subjects will be included with the absence of 2-4 teeth in the posterior region of the maxilla or mandibular. Twenty patients will be recruited. Two implant placement depths, equicrestal and subcrestal, were randomly assigned to two sites of each patient with a predefined randomization tables (one crestal implant and one subcrestal implant). Patients will be recalled for oral hygiene maintenance and prosthetic controls at 1year, 3 years, 5 years after final restoration.

Official Title
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Clinical and Radiographic Evaluation of Marginal Bone Changes Around Platform-switching Implants Placed in Crestal or Subcrestal Positions: a Randomized Controlled Clinical Trial

Conditions
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Jaw, Edentulous, Partial Edentulism

Intervention / Treatment
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* Procedure: Crestal
* Procedure: Subcrestal


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Absence of 2-4 teeth in the posterior region of the maxilla or mandibular; Bone volume sufficient for implants with 4.1-mm size and 8- to 12-mm height and with no need for hard or soft tissue augmentation for implant treatment; Periodontally healthy. Exclusion Criteria: Systemic diseases that may affect bone and soft tissue healing, such as diabetes, osteoporosis, Paget's disease, and patients with cancer; Uncontrolled periodontal disease or poor oral health with neither good nor adequate plaque control; Parafunctional habits, such as the grinding or clenching of teeth; Smoking habit (more than 10 cigarettes per day); Pregnancy and breastfeeding.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Crestal<br>Implants were placed with the implant-abutment interface(IAI) at the level of the the alveolar ridge | Procedure: Crestal<br>* Subjects will be included with the absence of 2-4 teeth in the posterior region of the maxilla or mandibular. Twenty patients will be recruited. Two implant placement depths, equicrestal and subcrestal, were randomly assigned to two sites of each patient with a predefined randomization tables (one crestal implant and one subcrestal implant).<br>|
| Experimental: Subcrestal<br>Implants were placed with the implant-abutment interface(IAI) 1 mm below the level of the alveolar ridge | Procedure: Subcrestal<br>* Subjects will be included with the absence of 2-4 teeth in the posterior region of the maxilla or mandibular. Twenty patients will be recruited. Two implant placement depths, equicrestal and subcrestal, were randomly assigned to two sites of each patient with a predefined randomization tables (one crestal implant and one subcrestal implant).<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Marginal bone loss(MBL) | Baseline will be recorded at the time of implantation. Margin bone loss(MBL) will be recorded at 0 day, 4 months, 1 year and 3 years after implant placement. | Change from baseline up to 5 years after implantation | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cumulative survival rate (CSR) | Cumulative survival rate will be assessed at final restoration, 1 year, 3 years, 5 years after final restoration | Up to 5 years after final restoration | 
| Pocket probing depth (PPD) | Pocket probing depth will be assessed at 1 year, 3 years, 5 years after final restoration | Up to 5 years after final restoration | 
| Plaque index (PI) | Plaque index will be assessed at 1 year, 3 years, 5 years after final restoration | Up to 5 years after final restoration | 
| Bleeding on probing (BOP) | Bleeding on probing will be assessed at 1 year, 3 years, 5 years after final restoration | Up to 5 years after final restoration | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Marginal Bone Loss, Implant depth, Crestal or Subcrestal