Clinical Trials Directory

Trials / Completed

CompletedNCT05562986

Impacts of Oral Irrigation in Orthodontic Patients

Clinical and Biochemical Evaluation Oral Irrigator Effectiveness in Patients Under Orthodontic Treatment

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
30 (actual)
Sponsor
Ondokuz Mayıs University · Academic / Other
Sex
All
Age
12 Years
Healthy volunteers
Not accepted

Summary

The present study aimed to investigate clinically the cleaning effectiveness of different treatment modalities, that is, oral irrigator or interdental brush usage addition to routine brushing and examine interleukin (IL)-1β, IL-10, matrix metalloproteinase (MMP)-1, MMP-8 levels in gingival crevicular fluid of orthodontic patients. The null hypothesis was that oral irrigators would be effective compared to interdental brush in the oral care of individuals who are orthodontic patients.

Detailed description

The aim of this study is to compare the effectiveness of oral irrigator (OI) with interdental brush (IB) clinically and biochemically in orthodontic patients. Thirty patients were randomly divided into two equal groups; patients using OI in addition to manuel brushing (OI-group), patients using IB in addition to manual brushing (IB-group). Study was planned as randomized, single-blind, parallel-design. Periodontal indexes were recorded clinically and interleukin (IL)-1β, IL-10, matrix metalloproteinase (MMP)-1, MMP-8 levels in gingival crevicular fluid were evaluated biochemically. After baseline examinations \[Silness-Löe plaque index(PI), Löe-Silness gingival index(GI), probing pocket depth(PPD), clinical attachment level(CAL), bleeding on probing(BOP)\], initial periodontal therapy was completed using full-mouth disinfection method. The data was collected in the baseline, 2nd, 4th and 8th weeks. The hypothesis of our study is that oral irrigators may be effective in oral care of orthodontic patients because of the ease of use.

Conditions

Interventions

TypeNameDescription
DIAGNOSTIC_TESTGCF (gingival crevicular fluid) collectionPrior to GCF (gingival crevicular fluid) sampling, supragingival plaque was removed by sterile curets and, after air drying, the surfaces were isolated by cotton rolls. Filter paper strips (periopaper, proflow Inc., Amityville, NewYork, USA) were placed in sulcus for 30s. Care was taken not to avoid mechanical trauma and strips contaminated with blood or saliva were discarded. The absorbed GCF volume was estimated by a calibrated instrument (periotron 8000, proflow Inc., Amityville, NY, USA). Then, the strips were sealed into sterile tubes before freezing at -80 0C. The readings were converted to an actual volume (μl) by reference to the standard curve.

Timeline

Start date
2018-03-01
Primary completion
2018-08-01
Completion
2018-12-27
First posted
2022-10-03
Last updated
2022-10-03

Locations

1 site across 1 country: Turkey (Türkiye)

Source: ClinicalTrials.gov record NCT05562986. Inclusion in this directory is not an endorsement.