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

Primary Purpose

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

Status
Recruiting
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Conventional transmucosal abutment design
Narrow transmucosal abutment design
Sponsored by
University of Santiago de Compostela
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Peri-implant Marginal Bone Loss focused on measuring periimplant bone loss, abutment design, transmucosal abutment

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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).

Sites / Locations

  • University of Santiago de CompostelaRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Experimental

Arm Label

Control Group

Test Group

Arm Description

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

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Probing pocket depth
measured with a CP12 probe as the distance from the soft tissue margin to the bottom of the peri-implant pocket
Papilla refill
Evaluated according to the Jemt 1997 index
Bleeding on probing
Evaluated according to the Mombelli 1987 index, presence of bleeding after probing
Plaque index
Evaluated according to the Mombelli 1987 index, presence of plaque
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
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

Full Information

First Posted
May 6, 2020
Last Updated
September 28, 2021
Sponsor
University of Santiago de Compostela
Collaborators
Mozo Grau Ticare Implants
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1. Study Identification

Unique Protocol Identification Number
NCT04385355
Brief Title
Influence of the Design of the Transmucosal Abutment on the Periimplant Bone Level
Official Title
Influence of the Design of the Transmucosal Abutment on the Marginal Periimplant Bone Loss. Randomized Clinical Trial
Study Type
Interventional

2. Study Status

Record Verification Date
September 2021
Overall Recruitment Status
Recruiting
Study Start Date
October 1, 2024 (Anticipated)
Primary Completion Date
October 31, 2024 (Anticipated)
Study Completion Date
November 1, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Santiago de Compostela
Collaborators
Mozo Grau Ticare Implants

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
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
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Peri-implant Marginal Bone Loss, Peri-implant Bone Level, Transmucosal Abutment Design, Peri-implant Bone Loss
Keywords
periimplant bone loss, abutment design, transmucosal abutment

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
For each participant on the test group will be another participant on the control group
Masking
ParticipantOutcomes Assessor
Masking Description
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.
Allocation
Randomized
Enrollment
36 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Control Group
Arm Type
Other
Arm Description
Control group will receive an intermediate transmucosal abutment with conventional diameter and 3mm height, once the implants are placed.
Arm Title
Test Group
Arm Type
Experimental
Arm Description
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
Intervention Type
Device
Intervention Name(s)
Conventional transmucosal abutment design
Intervention Description
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
Intervention Name(s)
Narrow transmucosal abutment design
Intervention Description
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
Primary Outcome Measure Information:
Title
Radiographic marginal periimplant bone level changes
Description
Measured as the distance from the bone crest to the first implant-to-bone contact. This will be assessed on parallelized periapical radiographies
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
Secondary Outcome Measure Information:
Title
Probing pocket depth
Description
measured with a CP12 probe as the distance from the soft tissue margin to the bottom of the peri-implant pocket
Time Frame
6 and 12 months after the definitive prostheses will be connected, and finally 3 years later
Title
Papilla refill
Description
Evaluated according to the Jemt 1997 index
Time Frame
6 and 12 months after the definitive prostheses will be connected, and finally 3 years later
Title
Bleeding on probing
Description
Evaluated according to the Mombelli 1987 index, presence of bleeding after probing
Time Frame
6 and 12 months after the definitive prostheses will be connected, and finally 3 years later
Title
Plaque index
Description
Evaluated according to the Mombelli 1987 index, presence of plaque
Time Frame
6 and 12 months after the definitive prostheses will be connected, and finally 3 years later
Title
Patient Reported Outcomes Measurements
Description
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
Time Frame
6 and 12 months after the definitive prostheses will be connected, and finally 3 years later
Title
Adverse effects frequency
Description
Presence of adverse effects during the follow-up, such as fracture of the implant or the prosthetic unit or presence of periimplantitis or mucositis
Time Frame
6 and 12 months after the definitive prostheses will be connected, and finally 3 years later

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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).
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Lucia Maceiras
Phone
+0034676780483
Email
luciamaceiraspombo@outlook.com
Facility Information:
Facility Name
University of Santiago de Compostela
City
Santiago De Compostela
State/Province
La Coruña
ZIP/Postal Code
15782
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lucia Maceiras
Phone
+0034676780483
Email
luciamaceiraspombo@outlook.com

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
24735458
Citation
Alves CC, Munoz F, Cantalapiedra A, Ramos I, Neves M, Blanco J. Marginal bone and soft tissue behavior following platform switching abutment connection/disconnection--a dog model study. Clin Oral Implants Res. 2015 Sep;26(9):983-91. doi: 10.1111/clr.12385. Epub 2014 Apr 16.
Results Reference
background
PubMed Identifier
8915028
Citation
Berglundh T, Lindhe J. Dimension of the periimplant mucosa. Biological width revisited. J Clin Periodontol. 1996 Oct;23(10):971-3. doi: 10.1111/j.1600-051x.1996.tb00520.x.
Results Reference
background
PubMed Identifier
29222809
Citation
Blanco J, Pico A, Caneiro L, Novoa L, Batalla P, Martin-Lancharro P. Effect of abutment height on interproximal implant bone level in the early healing: A randomized clinical trial. Clin Oral Implants Res. 2018 Jan;29(1):108-117. doi: 10.1111/clr.13108. Epub 2017 Dec 8. Erratum In: Clin Oral Implants Res. 2020 Oct;31(10):1037.
Results Reference
background
PubMed Identifier
7790533
Citation
Ericsson I, Persson LG, Berglundh T, Marinello CP, Lindhe J, Klinge B. Different types of inflammatory reactions in peri-implant soft tissues. J Clin Periodontol. 1995 Mar;22(3):255-61. doi: 10.1111/j.1600-051x.1995.tb00143.x.
Results Reference
background
PubMed Identifier
31180160
Citation
Koutouzis T, Adeinat B, Ali A. The influence of abutment macro-design on clinical and radiographic peri-implant tissue changes for guided, placed, and restored implants: A 1-year randomized controlled trial. Clin Oral Implants Res. 2019 Sep;30(9):882-891. doi: 10.1111/clr.13493. Epub 2019 Jun 24.
Results Reference
background
PubMed Identifier
28817138
Citation
Novoa L, Batalla P, Caneiro L, Pico A, Linares A, Blanco J. Influence of Abutment Height on Maintenance of Peri-implant Crestal Bone at Bone-Level Implants: A 3-Year Follow-up Study. Int J Periodontics Restorative Dent. 2017 Sep/Oct;37(5):721-727. doi: 10.11607/prd.2762.
Results Reference
background
PubMed Identifier
30246409
Citation
Souza AB, Alshihri A, Kammerer PW, Araujo MG, Gallucci GO. Histological and micro-CT analysis of peri-implant soft and hard tissue healing on implants with different healing abutments configurations. Clin Oral Implants Res. 2018 Oct;29(10):1007-1015. doi: 10.1111/clr.13367. Epub 2018 Sep 23.
Results Reference
background

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

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