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

Not Applicable

• Conditions: Peri-implant Mucositis
• Interventions: Diagnostic Test: Repeated removal and re-placement of healing and prosthetic abutments

• Registration Number: NCT04415801
• Lead Sponsor: University of Roma La Sapienza

Brief Summary

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

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.

Study Timeline

• Status Verified: 2020-05
• Study Start: 2020-05-01
• Study First Submitted: 2020-05-24
• Primary Completion: 2020-05-31
• Study Completion: 2020-05-31
• Study First Submitted QC: 2020-05-31
• Last Update Submitted: 2020-06-03
• Study First Posted: 2020-06-04
• Last Update Posted: 2020-06-05

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 20

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,

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
Implant abutments	Repeated removal and re-placement of healing and prosthetic abutments	implant abutments

Primary Outcome Measures

Name	Time	Method
change from baseline to 8 weeks of gingival fluid production	8 weeks	The gingival fluid production was measured electronically in Periotron units, (Periotron 8000®, Ora Flow, Inc., Plainview, NY, USA) which were converted to microliters (μl) by MCCONVRT software (Ora Flow).

Trial Locations

Locations (1)

Universita la Sapienza; 🇮🇹 Roma, Italy