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

September 28, 2021 updated by: Juan Blanco Carrión, University of Santiago de Compostela

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

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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Anticipated)

36

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Spain
    • La Coruña
      • Santiago De Compostela, La Coruña, Spain, 15782

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Control Group
Control group will receive an intermediate transmucosal abutment with conventional diameter and 3mm height, once the implants are placed.
Device: 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
Experimental: 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
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Radiographic marginal periimplant bone level changes
Time Frame: from baseline (connection of the definitive abutment) to 6 and 12 months after the definitive prostheses will be connected, and finally 3 years later
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
Time Frame: 6 and 12 months after the definitive prostheses will be connected, and finally 3 years later
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
Time Frame: 6 and 12 months after the definitive prostheses will be connected, and finally 3 years later
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
Time Frame: 6 and 12 months after the definitive prostheses will be connected, and finally 3 years later
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
Time Frame: 6 and 12 months after the definitive prostheses will be connected, and finally 3 years later
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
Time Frame: 6 and 12 months after the definitive prostheses will be connected, and finally 3 years later
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
Time Frame: 6 and 12 months after the definitive prostheses will be connected, and finally 3 years later
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Santiago de Compostela

Collaborators

Mozo Grau Ticare Implants

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

October 1, 2024

Primary Completion (Anticipated)

October 31, 2024

Study Completion (Anticipated)

November 1, 2024

Study Registration Dates

First Submitted

May 6, 2020

First Submitted That Met QC Criteria

May 9, 2020

First Posted (Actual)

May 12, 2020

Study Record Updates

Last Update Posted (Actual)

September 29, 2021

Last Update Submitted That Met QC Criteria

September 28, 2021

Last Verified

September 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ECRMGTCP2020

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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