Oral Hygiene and Systemic Inflammation (Perio-Hygiene 1.0)

NCT03848351 | Completed

• 1 other identifier: 984/2019
• Study Type: interventional
• Target: 140
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (1)

• Change from baseline of High sensitivity C-Reactive Protein (hsCRP) at 1 month

  analyzed though blood sampling. Unit of measure: mg/L

  Difference of values of the markers collected at Baseline and 1 month after treatment

Secondary Outcomes (12)

• Change from baseline of Interleukin 6 at 1 month

  Difference of values of the markers collected at Baseline and 1 month after treatment

• Vitamin D

  Collected at Baseline

• Full-mouth plaque score (FMPS)

  Measured at Baseline and 1 month after treatment

• Full-mouth bleeding score (FMBS)

  Measured at Baseline and 1 month after treatment

• Pocket probing depth (PPD)

  Measured at Baseline and 1 month after treatment

Study Arms (2)

Control Group

NO INTERVENTION

70 patients not receiving oral hygiene instructions or devices and continuing with their routine oral hygiene habits

Test Group

ACTIVE COMPARATOR

70 patients receiving intense oral hygiene instructions assisted by specific software or devices as well as oral hygiene (OH) tools (electric toothbrush, interdental floss, toothpaste) Thus, interventions will consist of. * Oral Hygiene Instruction (OHI) * Professional supragingival scaling and polishing

Behavioral: Oral Hygiene Instruction (OHI); Procedure: Professional supragingival scaling and polishing

Interventions

Oral Hygiene Instruction (OHI) BEHAVIORAL

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.

Test Group

Professional supragingival scaling and polishing PROCEDURE

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.

Test Group

Eligibility Criteria

• Age: 18 Years - 79 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• male or female, 18 to 79 of age, of any race/ethnicity;
• presence of at least 20 teeth;
• ≤ 2 untreated dental caries;
• presence of relevant plaque accumulation as shown by Full Mouth Plaque Scores (FMBS) \>50%.
• presence of relevant periodontal/gingival inflammation as shown by FMBS \> 35%

You may not qualify if:

• pregnancy and breast feeding;
• patients undergoing pharmacological treatment capable of reducing CRP such as statins or chronic anti-inflammatory treatment,
• current or past (≤ 30 days) systemic or local antibiotic therapy;
• heavy smokers (over 20 cigarettes per day or pipe or cigar);
• patients undergoing orthodontic treatment;
• patients not capable to comply with given instruction or administrative issues related to the study
• dental or periodontal conditions (e.g., deep caries, periodontal abscess) requiring urgent treatment

Sponsors & Collaborators

• University of Pisa: lead

Study Sites (1)

University Hospital of Pisa

Pisa, 56126, Italy

Location

Related Publications (1)

• Peric M, Marhl U, Gennai S, Marruganti C, Graziani F. Treatment of gingivitis is associated with reduction of systemic inflammation and improvement of oral health-related quality of life: A randomized clinical trial. J Clin Periodontol. 2022 Sep;49(9):899-910. doi: 10.1111/jcpe.13690. Epub 2022 Jul 17.

  PMID: 35762095 DERIVED

MeSH Terms

Conditions

Gingivitis

Condition Hierarchy (Ancestors)

Infections; Gingival Diseases; Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Outcome assessor will not be present during explanation of oral hygiene maneuvers. Moreover, participants will be asked not to mention about techniques and group participation to the outcome assessors.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Full Professor of Dentistry

Model Details: Single-centre randomized, parallel design, clinical trial with a 1-month follow-up

Study Record Dates

• First Submitted: February 15, 2019
• First Posted: February 20, 2019
• Study Start: April 1, 2019
• Primary Completion: May 4, 2021
• Study Completion: May 4, 2021
• Last Updated: November 7, 2022

Record last verified: 2022-11

Locations

IT (1)