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

Study Results

Results pending

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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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

36 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-10-01

Study Completion Date

2024-11-01

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

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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.

Conditions

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

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

For each participant on the test group will be another participant on the control group

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

None of the participants or the outcomes assessor will know the device (transmucosal abutment) received. The care provider will connect the transmucosal abutment while the surgery, after opening the randomization envelope; and the investigator will identify the participant's group while analysing the radiographs.

Study Groups

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Control Group

Control group will receive an intermediate transmucosal abutment with conventional diameter and 3mm height, once the implants are placed.

Group Type OTHER

Conventional transmucosal abutment design

Intervention Type DEVICE

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

Test Group

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

Group Type EXPERIMENTAL

Narrow transmucosal abutment design

Intervention Type DEVICE

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

Interventions

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Conventional transmucosal abutment design

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

Intervention Type DEVICE

Narrow transmucosal abutment design

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

Intervention Type DEVICE

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).

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No