Effect of the Abutment-Prosthesis Connection on Marginal Bone Loss and Gingival Sealing Around Dental Implants

Jaw, Edentulous, Partially Clinical Trial

Official title:

Effect of the Abutment-Prosthesis Connection on Marginal Bone Loss and Gingival Sealing Around Dental Implants

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05883202
• Other study ID #: 2622CEIH2022
• Status: Recruiting
• Phase: N/A
• Start date: July 10, 2023
• Est. completion date: July 31, 2025

Study information

• Verified date: July 2023
• Source: Universidad de Granada
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

In dental implant restoration, available literature demonstrates the advantage of using tall abutments, with a change of diameter with respect to the implant and a conical internal connection in the abutment-implant gap. However, for multiple restorations, the abutment-prosthesis connection has not been studied in detail. The "multi-unit" systems, both standard and brand specific, have either a flat or butt joint or an cone. In any case, both are external connection systems. Recently, an internal-type abutment-prosthesis connection system has been developed. Although it is proving its usefulness in single restorations, its use in multiple restorations compared to traditional systems has not been studied.

Therefore, taking into account all of the above, the present study has the overall objective of analyzing marginal bone loss (MBL) and adaptation of soft tissues by comparing a multiple prosthesis system of the "external, flat" type versus an external system of the "internal, conical" type.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: July 31, 2025
• Est. primary completion date: May 31, 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

Inclusion criteria:

• Kennedy class I or II (unilateral or bilateral free end) or III (posterior intermediate edentulous section) mandibular requiring 2 implants to restore at least 2 molars, 2 molars and 1 premolar, or 2 premolars and 1 molar.

• Possibility of placing a transgingival abutment at least 2 mm high.

Exclusion criteria:

• Need for simultaneous bone augmentation.

• Heavy smokers (>10 cigarettes/day).

• Uncontrolled type 1 or 2 diabetes (HgA1c>8).

• Known autoimmune or inflammatory disease.

• Serious blood disorders, such as hemophilia or leukemia.

• Local or systemic infection that may compromise normal healing (e.g., extensive periapical pathology).

• Liver or kidney dysfunction/failure.

• Currently receiving cancer treatment or within 18 months from completion of radio- or chemotherapy.

• Long-term history of oral bisphosphonates use (i.e., 10 years or more).

• History of intravenous bisphosphonates.

• Long-term (>3 months) history of antibiotics or drugs known to alter the inflammation and/or immunological system 3 months before inclusion.

• Severe osseous diseases (e.g., Paget disease of bone).

• Pregnant women or nursing mothers.

• Not able or not willing to follow instructions related to the study procedures.

Related Conditions & MeSH terms

• Jaw, Edentulous
• Jaw, Edentulous, Partially

Intervention

Device:
• Connect®
Restoration of multiple implants with a Connect® abutment between the implant and the prosthesis.
• Multi-unit
Restoration of multiple implants with a conventional multi-unit abutment between the implant and the prosthesis.

Locations

Country	Name	City	State
Spain	Universidad de Granada	Granada

Sponsors (1)

Lead Sponsor	Collaborator
Universidad de Granada

Country where clinical trial is conducted

Spain, 

References & Publications (2)

Couso-Queiruga E, Tattan M, Ahmad U, Barwacz C, Gonzalez-Martin O, Avila-Ortiz G. Assessment of gingival thickness using digital file superimposition versus direct clinical measurements. Clin Oral Investig. 2021 Apr;25(4):2353-2361. doi: 10.1007/s00784-020-03558-0. Epub 2020 Aug 31. — View Citation

Galindo-Moreno P, Leon-Cano A, Ortega-Oller I, Monje A, Suarez F, OValle F, Spinato S, Catena A. Prosthetic Abutment Height is a Key Factor in Peri-implant Marginal Bone Loss. J Dent Res. 2014 Jul;93(7 Suppl):80S-85S. doi: 10.1177/0022034513519800. Epub 2014 Mar 12. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Soft-tissue volume	Three-dimensional volume of the soft tissue around the implants	1 year
Primary	Marginal bone level	Peri-implant marginal bone level measured by standardized periapical radiography	1 year
Secondary	Peri-implant microbiome	Relative abundance of microbial species in the peri-implant sulcus evaluated by next-generation sequencing methods	1 year
Secondary	Peri-implant inflammation	Concentration of pro-inflammatory markers in the peri-implant sulcus evaluated by multiplex techniques methods	1 year