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Oral Hygiene and Systemic Inflammation (Perio-Hygiene 1.0)

NCT03848351 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 140

Last updated 2022-11-07

No results posted yet for this study

Summary

The purpose of the study is to evaluate the impact of oral hygiene changes (drastic plaque and gingival inflammation reduction) on markers of systemic inflammation and indicators of oral health related quality of life and other aspects related to overall well-being.

The primary objective is to assess a possible reduction of systemic inflammation as measured through blood bio-markers one month after drastic changes of plaque accumulation. As primary outcome measure, the level of high-sensitive C-reactive protein (hs-CRP) will be assessed.

Conditions

  • Gingivitis

Interventions

BEHAVIORAL

Oral Hygiene Instruction (OHI)

OHI will be given focusing on electric toothbrushing as first instance and subsequently focusing on interdental cleaning. OHI will be delivered by trained dental hygienist/periodontist. In the first phase the clinician will explain and show the technique to the patient. The patient will be then invited to perform the technique. Each phase will be assisted and monitored by the clinician. Overall, this sequence may be repeated as many times as the clinician would deem appropriate.

PROCEDURE

Professional supragingival scaling and polishing

Patients will receive a session of professional supragingival scaling and polishing, that consists of removal of dental plaque and dental calculus from the surface of a tooth, with great care in performing exclusively coronal maneuver. No instrumentation or exploring of the gingival crevice/ sulcus will be performed. Instrumentation will be performed by a trained dental hygienist/periodontist.

Sponsors & Collaborators

  • University of Pisa

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
79 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2019-04-01
Primary Completion
2021-05-04
Completion
2021-05-04

Countries

  • Italy

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03848351 on ClinicalTrials.gov