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

NCT ID: NCT05883202

Last Updated: 2024-12-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-07-10

Study Completion Date

2026-07-31

Brief Summary

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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.

Detailed Description

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Conditions

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Jaw, Edentulous, Partially

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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Connect®

Restoration of multiple implants with a Connect® abutment between the implant and the prosthesis.

Group Type EXPERIMENTAL

Connect®

Intervention Type DEVICE

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.

Group Type ACTIVE_COMPARATOR

Multi-unit

Intervention Type DEVICE

Restoration of multiple implants with a conventional multi-unit abutment between the implant and the prosthesis.

Interventions

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Connect®

Restoration of multiple implants with a Connect® abutment between the implant and the prosthesis.

Intervention Type DEVICE

Multi-unit

Restoration of multiple implants with a conventional multi-unit abutment between the implant and the prosthesis.

Intervention Type DEVICE

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Universidad de Granada

OTHER

Sponsor Role lead

Responsible Party

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Miguel Padial-Molina

Associate Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Universidad de Granada

Granada, , Spain

Site Status

Countries

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Spain

References

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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.

Reference Type BACKGROUND
PMID: 24621670 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 32865627 (View on PubMed)

Other Identifiers

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2622CEIH2022

Identifier Type: -

Identifier Source: org_study_id