Effect of Repeated Removal and Re-placement of Abutments Around Dental Implants

NCT ID: NCT04415801

Last Updated: 2020-06-05

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

UNKNOWN

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-05-01

Study Completion Date

2020-05-31

Brief Summary

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Repeated removal and re-placement of healing and prosthetic abutments result in frequent injuries to the soft tissues. The purpose was to evaluate the effect of repeated removal and re-placement of laser microgrooved and smooth/machined healing and prosthetic abutments during restorative stages, and 1 year after functional loading, on proinflammatory cytokine levels around dental implants.

Detailed Description

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Twenty-four patients each received 2 one-stage implants in a split mouth design on the same jaw. In each patient one healing and prosthetic abutments with a laser microgrooved surface (LMS group) and one healing and prosthetic abutments with smooth/machined surface (S/MS group) were used. Four months following implant placement \[Baseline (BSL)\], the healing abutments were disconnnected and reconnected three times to carry out the impression procedures and metal framework try-in. Four weeks later (T0), definitive prosthetic abutments were installated with screw retained crowns. Samples for immunological analyses were taken from the sulcus around each implant at BSL, T0, and 1 year after functional loading (T1). Peri-implant crevicular fluid samples were analyzed for interleukin-1beta (IL-1β), interleukin-6 (IL-6) and tumor necrosis factor (TNF)-α levels using the ELISA kit.

Conditions

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Peri-implant Mucositis

Study Design

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Intervention Model

SEQUENTIAL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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Implant abutments

implant abutments

Group Type EXPERIMENTAL

Repeated removal and re-placement of healing and prosthetic abutments

Intervention Type DIAGNOSTIC_TEST

Repeated removal and re-placement of healing and prosthetic abutments

Interventions

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Repeated removal and re-placement of healing and prosthetic abutments

Repeated removal and re-placement of healing and prosthetic abutments

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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Inclusion Criteria

* 18 years or older, in good general health, and with sufficient amount of bone available to place a standard implant

Exclusion Criteria

* natural teeth adjacent to surgical area affected by untreated periodontal or endodontic infections, peri-implant bone defects requiring bone augmentation, absence of opposing occlusion,
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University of Roma La Sapienza

OTHER

Sponsor Role lead

Responsible Party

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Renzo Guarnieri

Adjunct Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Renzo Guarnieri

Role: PRINCIPAL_INVESTIGATOR

University La Sapienza Roma Italy

Locations

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Universita la Sapienza

Roma, , Italy

Site Status RECRUITING

Countries

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Italy

Central Contacts

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Renzo Guarnieri, MD DDS

Role: CONTACT

+39 3425224458

Renzo Guarnieri

Role: CONTACT

Facility Contacts

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Renzi Guarnieri, MD DDS

Role: primary

+39 342 5224458

References

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Guarnieri R, Miccoli G, Reda R, Mazzoni A, Di Nardo D, Testarelli L. Laser microgrooved vs. machined healing abutment disconnection/reconnection: a comparative clinical, radiographical and biochemical study with split-mouth design. Int J Implant Dent. 2021 Mar 17;7(1):19. doi: 10.1186/s40729-021-00301-6.

Reference Type DERIVED
PMID: 33728493 (View on PubMed)

Other Identifiers

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3/20

Identifier Type: -

Identifier Source: org_study_id

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