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

Peri-implant Bone Loss Clinical Trial

Official title:

Influence of the Design of the Transmucosal Abutment on the Marginal Periimplant Bone Loss. Randomized Clinical Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04385355
• Other study ID #: ECRMGTCP2020
• Status: Recruiting
• Phase: N/A
• Start date: October 1, 2024
• Est. completion date: November 1, 2024

Study information

• Verified date: September 2021
• Source: University of Santiago de Compostela
• Contact: Lucia Maceiras
• Phone: +0034676780483
• Email: luciamaceiraspombo[@]outlook.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 36
• Est. completion date: November 1, 2024
• Est. primary completion date: October 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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).

Related Conditions & MeSH terms

• Bone Diseases, Metabolic
• Peri-implant Bone Level
• Peri-implant Bone Loss
• Peri-implant Marginal Bone Loss
• Transmucosal Abutment Design

Intervention

Device:
• Conventional transmucosal abutment design
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
• Narrow transmucosal abutment design
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

Locations

Country	Name	City	State
Spain	University of Santiago de Compostela	Santiago De Compostela	La Coruña

Sponsors (2)

Lead Sponsor	Collaborator
University of Santiago de Compostela	Mozo Grau Ticare Implants

Country where clinical trial is conducted

Spain, 

References & Publications (7)

Alves CC, Muñoz 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. — View Citation

Berglundh T, Lindhe J. Dimension of the periimplant mucosa. Biological width revisited. J Clin Periodontol. 1996 Oct;23(10):971-3. — View Citation

Blanco J, Pico A, Caneiro L, Nóvoa L, Batalla P, Martín-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. — View 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. — View 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. — View Citation

Nóvoa L, Batalla P, Caneiro L, Pico A, Liñares 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. — View Citation

Souza AB, Alshihri A, Kämmerer PW, Araújo 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Probing pocket depth	measured with a CP12 probe as the distance from the soft tissue margin to the bottom of the peri-implant pocket	6 and 12 months after the definitive prostheses will be connected, and finally 3 years later
Secondary	Papilla refill	Evaluated according to the Jemt 1997 index	6 and 12 months after the definitive prostheses will be connected, and finally 3 years later
Secondary	Bleeding on probing	Evaluated according to the Mombelli 1987 index, presence of bleeding after probing	6 and 12 months after the definitive prostheses will be connected, and finally 3 years later
Secondary	Plaque index	Evaluated according to the Mombelli 1987 index, presence of plaque	6 and 12 months after the definitive prostheses will be connected, and finally 3 years later
Secondary	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	6 and 12 months after the definitive prostheses will be connected, and finally 3 years later
Secondary	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	6 and 12 months after the definitive prostheses will be connected, and finally 3 years later