Influence of the Design of the Transmucosal Abutment on the Periimplant Bone Level

Study Overview
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Brief Summary
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The objective of this study is to evaluate the radiographic changes on the marginal peri-implant bone level on bone level implants with a narrower transmucosal abutment, in comparison to the conventional abutment, both of 3mm height

Detailed Description
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Patients will receive from one to eight bone-level implants according to their rehabilitation necessity and transmucosal abutments will be connected the day of the surgery. The control group will receive conventional transmucosal abutments while the test group will receive TCP abutments, with a narrower design. Results will be evaluated initially 6 and 12 months after the connection of the definitive prostheses, and finally 3 years later.

Official Title
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Influence of the Design of the Transmucosal Abutment on the Marginal Periimplant Bone Loss. Randomized Clinical Trial

Conditions
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Peri-implant Marginal Bone Loss, Peri-implant Bone Level, Transmucosal Abutment Design, Peri-implant Bone Loss

Intervention / Treatment
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* Device: Conventional transmucosal abutment design
* Device: Narrow transmucosal abutment design


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Absence of systemic and periodontal pathology, over 18 years of age, with a plaque index below 25%. Absence of at least one tooth, with natural adjacent teeth, allowing a prosthetic rehabilitation with an osseointegrated implant and a prosthetic unit. Adequate bone quality available, allowing placement of MOZO GRAU® implants InHex STD QUATTRO with diameters of 3.75 mm or 4.25 mm and lengths of 8, 10 and 11.5 mm. Natural teeth or implants with fixed restoration as antagonists. Exclusion Criteria: Systemic factors: Continuous administration of systemic medication that can interfere with the bone metabolism or medical conditions requiring prolonged use of steroids and / or medications that can interfere with bone metabolism. History of leukocyte dysfunction and deficiency, immunodeficiency syndromes, kidney failure or bone metabolic disorders, such as osteoporosis. Physical disability that may interfere with proper oral hygiene. Use of any investigational medication or device within the previous 30 days to implant surgery in the study. Alcoholism or drug addiction Smoker of more than 10 cigarettes per day. Conditions or circumstances that could prevent compliance with participation in study or interfere with the analysis of results, such as a history of breach or unreliability. Local factors: History of local radiotherapy. Bruxism. Diseases that affect the oral mucosa, such as oral lichen planus. Untreated periodontitis. Persistent intraoral infection. Post-extraction alveoli not cured (less than 6 weeks after extraction).

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

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
Interventional Model Description: For each participant on the test group will be another participant on the control group
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Control Group<br>Control group will receive an intermediate transmucosal abutment with conventional diameter and 3mm height, once the implants are placed. | Device: Conventional transmucosal abutment design<br>* The macroscopic design of the intermediate transmucosal abutment will be evaluated on terms of the marginal peri-implant bone levels using two identical devices, if only being the test device narrower than the control one<br>|
| Experimental: Test Group<br>Test group will receive an intermediate transmucosal abutment with a TCP design, narrower than the conventional one, of 3mm height, once the implants are placed | Device: Narrow transmucosal abutment design<br>* The macroscopic design of the intermediate transmucosal abutment will be evaluated on terms of the marginal peri-implant bone levels using two identical devices, if only being the test device narrower than the control one<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Radiographic marginal periimplant bone level changes | Measured as the distance from the bone crest to the first implant-to-bone contact. This will be assessed on parallelized periapical radiographies | from baseline (connection of the definitive abutment) to 6 and 12 months after the definitive prostheses will be connected, and finally 3 years later | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Probing pocket depth | measured with a CP12 probe as the distance from the soft tissue margin to the bottom of the peri-implant pocket | 6 and 12 months after the definitive prostheses will be connected, and finally 3 years later | 
| Papilla refill | Evaluated according to the Jemt 1997 index | 6 and 12 months after the definitive prostheses will be connected, and finally 3 years later | 
| Bleeding on probing | Evaluated according to the Mombelli 1987 index, presence of bleeding after probing | 6 and 12 months after the definitive prostheses will be connected, and finally 3 years later | 
| Plaque index | Evaluated according to the Mombelli 1987 index, presence of plaque | 6 and 12 months after the definitive prostheses will be connected, and finally 3 years later | 
| Patient Reported Outcomes Measurements | Using a visual analoge scale from 1 to 10 to evaluate patient's satisfaction parameters related to the aesthetics, masticatory ability, confort, general satisfaction and phonetics | 6 and 12 months after the definitive prostheses will be connected, and finally 3 years later | 
| Adverse effects frequency | Presence of adverse effects during the follow-up, such as fracture of the implant or the prosthetic unit or presence of periimplantitis or mucositis | 6 and 12 months after the definitive prostheses will be connected, and finally 3 years later | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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periimplant bone loss, abutment design, transmucosal abutment