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

Not Applicable

Recruiting

• Conditions: Peri-implant Bone Level; Transmucosal Abutment Design; Peri-implant Bone Loss; Peri-implant Marginal Bone Loss
• Interventions: Device: Narrow transmucosal abutment design; Device: Conventional transmucosal abutment design

• Registration Number: NCT04385355
• Lead Sponsor: University of Santiago de Compostela

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.

Study Timeline

• Study First Submitted: 2020-05-06
• Study First Submitted QC: 2020-05-09
• Study First Posted: 2020-05-12
• Status Verified: 2021-09
• Last Update Submitted: 2021-09-28
• Last Update Posted: 2021-09-29
• Study Start: 2024-10-01
• Primary Completion: 2024-10-31
• Study Completion: 2024-11-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 36

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Test Group	Narrow transmucosal abutment design	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
Control Group	Conventional transmucosal abutment design	Control group will receive an intermediate transmucosal abutment with conventional diameter and 3mm height, once the implants are placed.

Primary Outcome Measures

Name	Time	Method
Radiographic marginal periimplant bone level changes	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

Secondary Outcome Measures

Name	Time	Method
Bleeding on probing	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
Probing pocket depth	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
Papilla refill	6 and 12 months after the definitive prostheses will be connected, and finally 3 years later	Evaluated according to the Jemt 1997 index
Patient Reported Outcomes Measurements	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
Plaque index	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
Adverse effects frequency	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

Trial Locations

Locations (1)

University of Santiago de Compostela; 🇪🇸 Santiago De Compostela, La Coruña, Spain