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

University of Santiago de Compostela

Status: Enrolling

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

Treatments: Device: Conventional transmucosal abutment design; Device: Narrow transmucosal abutment design

Study type: Interventional

Funder types: Other

Identifiers

NCT04385355

ECRMGTCP2020

Details and patient eligibility

About

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

Full 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.

Enrollment: 36 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No 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).

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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36 participants in 2 patient groups

Control Group

Other group

Description:

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

Treatment:

Device: Conventional transmucosal abutment design

Test Group

Experimental group

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

Treatment:

Device: Narrow transmucosal abutment design