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

Peri-implant Mucositis Clinical Trial

Official title:

Effect of Repeated Removal and Re-placement of Laser Microgrooved and Machined Abutments on Proinflammatory Cytokine Levels Around Dental Implants

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04415801
• Other study ID #: 3/20
• Status: Recruiting
• Phase: N/A
• Start date: May 1, 2020
• Est. completion date: May 31, 2020

Study information

• Verified date: May 2020
• Source: University of Roma La Sapienza
• Contact: Renzo Guarnieri, MD DDS
• Phone: +39 3425224458
• Email: renzoguarnieri[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: May 31, 2020
• Est. primary completion date: May 31, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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,

Related Conditions & MeSH terms

• Mucositis
• Peri-implant Mucositis

Intervention

Diagnostic Test:
• Repeated removal and re-placement of healing and prosthetic abutments
Repeated removal and re-placement of healing and prosthetic abutments

Locations

Country	Name	City	State
Italy	Universita la Sapienza	Roma

Sponsors (1)

Lead Sponsor	Collaborator
University of Roma La Sapienza

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	change from baseline to 8 weeks of gingival fluid production	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).	8 weeks