Clinical trial NCT04385355: 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
Overall status: UNKNOWN
Phase: NA
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
Lead sponsor: University of Santiago de Compostela
Sponsor class: OTHER
Collaborators: name: Mozo Grau Ticare Implants
First posted: 2020-05-12
Enrollment: 36
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: For each participant on the test group will be another participant on the control group
Primary purpose: TREATMENT

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.

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).

Primary outcomes:
measure: Radiographic marginal periimplant bone level changes
timeFrame: 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:
measure: Probing pocket depth
timeFrame: 6 and 12 months after the definitive prostheses will be connected, and finally 3 years later
measure: Papilla refill
timeFrame: 6 and 12 months after the definitive prostheses will be connected, and finally 3 years later
measure: Bleeding on probing
timeFrame: 6 and 12 months after the definitive prostheses will be connected, and finally 3 years later
measure: Plaque index
timeFrame: 6 and 12 months after the definitive prostheses will be connected, and finally 3 years later
measure: Patient Reported Outcomes Measurements
timeFrame: 6 and 12 months after the definitive prostheses will be connected, and finally 3 years later
measure: Adverse effects frequency
timeFrame: 6 and 12 months after the definitive prostheses will be connected, and finally 3 years later
Other outcomes:
Locations:
city: Santiago De Compostela
country: Spain
facility: University of Santiago de Compostela
state: La Coruña
Study officials:
References:
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.
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.
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.
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.
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.
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.
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.