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

NCT04385355 | Unknown

• 1 other identifier: ECRMGTCP2020
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

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

Conditions

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

Keywords

periimplant bone loss; abutment design; transmucosal abutment

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• Probing pocket depth

  6 and 12 months after the definitive prostheses will be connected, and finally 3 years later

• Papilla refill

  6 and 12 months after the definitive prostheses will be connected, and finally 3 years later

• Bleeding on probing

  6 and 12 months after the definitive prostheses will be connected, and finally 3 years later

• Plaque index

  6 and 12 months after the definitive prostheses will be connected, and finally 3 years later

• Patient Reported Outcomes Measurements

  6 and 12 months after the definitive prostheses will be connected, and finally 3 years later

Study Arms (2)

Control Group

OTHER

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

Device: Conventional transmucosal abutment design

Test Group

EXPERIMENTAL

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

Interventions

Conventional transmucosal abutment design 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

Control Group

Narrow transmucosal abutment design 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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• University of Santiago de Compostela: lead
• Mozo Grau Ticare Implants: collaborator

Study Sites (1)

University of Santiago de Compostela

Santiago de Compostela, La Coruña, 15782, Spain

RECRUITING

Related Publications (7)

• 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.

  PMID: 24735458 BACKGROUND

• 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.

  PMID: 8915028 BACKGROUND

• 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.

  PMID: 29222809 BACKGROUND

• 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.

  PMID: 7790533 BACKGROUND

• 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.

  PMID: 31180160 BACKGROUND

• 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.

  PMID: 28817138 BACKGROUND

• 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.

  PMID: 30246409 BACKGROUND

Central Study Contacts

Lucia Maceiras

CONTACT

+0034676780483; luciamaceiraspombo@outlook.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: For each participant on the test group will be another participant on the control group

Study Record Dates

• First Submitted: May 6, 2020
• First Posted: May 12, 2020
• Study Start: October 1, 2024
• Primary Completion: October 31, 2024
• Study Completion: November 1, 2024
• Last Updated: September 29, 2021

Record last verified: 2021-09

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)