Clinical trial NCT05562986: Impacts of Oral Irrigation in Orthodontic Patients
Official title: Clinical and Biochemical Evaluation Oral Irrigator Effectiveness in Patients Under Orthodontic Treatment
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Oral Hygiene
Orthodontics
Periodontal Diseases
Keywords: Cytokine(s)
Matrix metalloproteinase(s)
Orthodontics
Oral hygiene
Lead sponsor: Ondokuz Mayıs University
Sponsor class: OTHER
First posted: 2022-10-03
Enrollment: 30
Sex: ALL
Minimum age (years): 12
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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.
Primary purpose: PREVENTION

Brief 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.

Eligibility criteria: Inclusion Criteria:

* Being over 12 years old.
* Having at least 20 permanent teeth with bands or brackets.
* Finished phase I periodontal treatment.
* Bleeding below 10% during probing.
* No pocket depth of more than 5 mm.
* Not receiving any treatment other than orthodontic treatment during the study.
* Absence of removable or fixed prosthetic restorations.
* Absence of any systemic disease (hepatic, renal, hematologic, cardiovascular).
* Agreeing not to use any non-study mouthwash throughout the study.

Exclusion Criteria:

* Performing poor cooperation.
* Having diseases associated with bacteriemia.
* Used antibiotics and anti-inflammatory drugs for any purpose for a long time.
* Having diabetes.
* Smoking habits.
* Having a physical or mental problem that affects manual dexterity.
* Using medication that could affect gingival health (such as dilantin, calcium channel blocker, cyclosporine, and anticoagulant).

Primary outcomes:
measure: GCF (gingival crevicular fluid) level of IL-1β as a marker of gingival inflammation
timeFrame: through study completion, an average of 1 year
measure: GCF (gingival crevicular fluid) level of IL-10 as a marker of gingival inflammation
timeFrame: through study completion, an average of 1 year
measure: GCF (gingival crevicular fluid) level of MMP-1 as a marker of gingival inflammation
timeFrame: through study completion, an average of 1 year
measure: GCF (gingival crevicular fluid) level of MMP-8 as a marker of gingival inflammation
timeFrame: through study completion, an average of 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Samsun
country: Turkey
facility: Ondokuz Mayıs University, Faculty of Dentistry, Department of Periodontology
Study officials:
affiliation: Ondokuzmayis University, Faculty of Dentistry, Department of Periodontology, Samsun, Turkey.
name: Burcu OZKAN CETINKAYA, Prof
role: STUDY_DIRECTOR
affiliation: Erzurum Public Oral Health Center, Erzurum, Turkey.
name: Esma SAHIN, Dr
role: PRINCIPAL_INVESTIGATOR
affiliation: Ondokuzmayis University, Faculty of Medicine Department of Biochemistry, Samsun, Turkey.
name: Bahattin AVCI, Prof
role: STUDY_CHAIR
affiliation: Ondokuzmayis University, Faculty of Dentistry, Department of Orthodontics, Samsun, Turkey.
name: Selma ELEKDAG TURK, Prof
role: STUDY_CHAIR
References: