Impacts of Oral Irrigation in Orthodontic Patients

NCT ID: NCT05562986

Last Updated: 2022-10-03

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-03-01
• Study Completion Date: 2018-12-27

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.

Conditions

Oral Hygiene; Orthodontics; Periodontal Diseases

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Oral irrigator group

Fifteen patients using toothbrush and oral irrigator (Aquapick, AQ-300, Aquapick Co, Ltd, Korea). All patients were told to use Modified Bass method of tooth brushing technique. PI, GI, PPD and CAL values were measured with William's probe (Hu-Fried, Chicago, IL, A.B.D) around the teeth. All clinical parameters were evaluated on each of the six regions of the teeth (mesio-buccal, mid-buccal, disto-buccal, mesio-lingual, mid-lingual, disto-lingual). GCF (gingival crevicular fluid) samples was collected one day after the clinical examination from buccal aspects of the mesial and distal surfaces at the interproximal sites for the evaluation of interleukin (IL)-1β, IL-10, matrix metalloproteinase (MMP)-1, MMP-8 mediators. Following the initial clinical records, all patients were performed full mouth instrumentation and described oral hygiene procedure according to their groups.

Group Type: EXPERIMENTAL

GCF (gingival crevicular fluid) collection

Intervention Type: DIAGNOSTIC_TEST

Prior 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.

Interdental brush group

Fifteen patients using toothbrush and interdental brush. All patients were told to use Modified Bass method of tooth brushing technique. PI, GI, PPD and CAL values were measured with William's probe (Hu-Fried, Chicago, IL, A.B.D) around the teeth. All clinical parameters were evaluated on each of the six regions of the teeth (mesio-buccal, mid-buccal, disto-buccal, mesio-lingual, mid-lingual, disto-lingual). GCF (gingival crevicular fluid) samples was collected one day after the clinical examination from buccal aspects of the mesial and distal surfaces at the interproximal sites for the evaluation of interleukin (IL)-1β, IL-10, matrix metalloproteinase (MMP)-1, MMP-8 mediators. Following the initial clinical records, all patients were performed full mouth instrumentation and described oral hygiene procedure according to their groups.

Group Type: EXPERIMENTAL

GCF (gingival crevicular fluid) collection

Intervention Type: DIAGNOSTIC_TEST

Prior 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.

Interventions

GCF (gingival crevicular fluid) collection

Prior 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.

Intervention Type: DIAGNOSTIC_TEST

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).

• Minimum Eligible Age: 12 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Ondokuz Mayıs University

OTHER

Sponsor Role: lead

Responsible Party

Burcu Ozkan Cetinkaya

Professor in Periodontology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Burcu OZKAN CETINKAYA, Prof

Role: STUDY_DIRECTOR

Ondokuzmayis University, Faculty of Dentistry, Department of Periodontology, Samsun, Turkey.

Esma SAHIN, Dr

Role: PRINCIPAL_INVESTIGATOR

Erzurum Public Oral Health Center, Erzurum, Turkey.

Bahattin AVCI, Prof

Role: STUDY_CHAIR

Ondokuzmayis University, Faculty of Medicine Department of Biochemistry, Samsun, Turkey.

Selma ELEKDAG TURK, Prof

Role: STUDY_CHAIR

Ondokuzmayis University, Faculty of Dentistry, Department of Orthodontics, Samsun, Turkey.

Locations

Ondokuz Mayıs University, Faculty of Dentistry, Department of Periodontology

Samsun, , Turkey (Türkiye)

Countries

Turkey (Türkiye)

Other Identifiers

B.30.2.ODM.0.20.08/1352-1377

Identifier Type: -

Identifier Source: org_study_id