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Impacts of Oral Irrigation in Orthodontic Patients

Primary Purpose

Oral Hygiene, Orthodontics, Periodontal Diseases

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
GCF (gingival crevicular fluid) collection
Sponsored by
Ondokuz Mayıs University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Oral Hygiene focused on measuring Cytokine(s), Matrix metalloproteinase(s), Orthodontics, Oral hygiene

Eligibility Criteria

12 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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).

Sites / Locations

  • Ondokuz Mayıs University, Faculty of Dentistry, Department of Periodontology

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Oral irrigator group

Interdental brush group

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

GCF (gingival crevicular fluid) level of IL-1β as a marker of gingival inflammation
Elevated levels of IL-1β in GCF have been associated with the destructive changes that occur in the inflamed human gingiva, is a proinflammatory cytokine.
GCF (gingival crevicular fluid) level of IL-10 as a marker of gingival inflammation
IL-10 plays an important role as a stop signal in suppressing the immune and inflammatory response by being released from periodontal tissues, thus trying to limit the spread and severity of the disease. It is an anti-inflammatory cytokine. It is reported that the level of GCF IL-10 is increased in inflamed areas.
GCF (gingival crevicular fluid) level of MMP-1 as a marker of gingival inflammation
One of the MMPs, MMP-1, is generally expressed by fibroblasts, endothelial cells, keratinocytes, monocytes/macrophages, chondrocytes, and osteoblasts, and is a key regulator in connective tissue remodeling. In addition to gingivitis, there is a significant increase in MMP-1 levels in the GCF during the active periods of periodontitis.
GCF (gingival crevicular fluid) level of MMP-8 as a marker of gingival inflammation
High concentration of MMP-8 is associated with tissue destruction and severity of periodontal disease. It is known to be secreted from inflammatory cells such as neutrophils and macrophages.

Secondary Outcome Measures

Full Information

First Posted
September 28, 2022
Last Updated
September 28, 2022
Sponsor
Ondokuz Mayıs University
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1. Study Identification

Unique Protocol Identification Number
NCT05562986
Brief Title
Impacts of Oral Irrigation in Orthodontic Patients
Official Title
Clinical and Biochemical Evaluation Oral Irrigator Effectiveness in Patients Under Orthodontic Treatment
Study Type
Interventional

2. Study Status

Record Verification Date
September 2022
Overall Recruitment Status
Completed
Study Start Date
March 1, 2018 (Actual)
Primary Completion Date
August 1, 2018 (Actual)
Study Completion Date
December 27, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ondokuz Mayıs University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Oral Hygiene, Orthodontics, Periodontal Diseases
Keywords
Cytokine(s), Matrix metalloproteinase(s), Orthodontics, Oral hygiene

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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.
Masking
None (Open Label)
Allocation
Randomized
Enrollment
30 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Oral irrigator group
Arm Type
Experimental
Arm Description
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.
Arm Title
Interdental brush group
Arm Type
Experimental
Arm Description
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.
Intervention Type
Diagnostic Test
Intervention Name(s)
GCF (gingival crevicular fluid) collection
Intervention Description
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.
Primary Outcome Measure Information:
Title
GCF (gingival crevicular fluid) level of IL-1β as a marker of gingival inflammation
Description
Elevated levels of IL-1β in GCF have been associated with the destructive changes that occur in the inflamed human gingiva, is a proinflammatory cytokine.
Time Frame
through study completion, an average of 1 year
Title
GCF (gingival crevicular fluid) level of IL-10 as a marker of gingival inflammation
Description
IL-10 plays an important role as a stop signal in suppressing the immune and inflammatory response by being released from periodontal tissues, thus trying to limit the spread and severity of the disease. It is an anti-inflammatory cytokine. It is reported that the level of GCF IL-10 is increased in inflamed areas.
Time Frame
through study completion, an average of 1 year
Title
GCF (gingival crevicular fluid) level of MMP-1 as a marker of gingival inflammation
Description
One of the MMPs, MMP-1, is generally expressed by fibroblasts, endothelial cells, keratinocytes, monocytes/macrophages, chondrocytes, and osteoblasts, and is a key regulator in connective tissue remodeling. In addition to gingivitis, there is a significant increase in MMP-1 levels in the GCF during the active periods of periodontitis.
Time Frame
through study completion, an average of 1 year
Title
GCF (gingival crevicular fluid) level of MMP-8 as a marker of gingival inflammation
Description
High concentration of MMP-8 is associated with tissue destruction and severity of periodontal disease. It is known to be secreted from inflammatory cells such as neutrophils and macrophages.
Time Frame
through study completion, an average of 1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
No
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).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Burcu OZKAN CETINKAYA, Prof
Organizational Affiliation
Ondokuzmayis University, Faculty of Dentistry, Department of Periodontology, Samsun, Turkey.
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Esma SAHIN, Dr
Organizational Affiliation
Erzurum Public Oral Health Center, Erzurum, Turkey.
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Bahattin AVCI, Prof
Organizational Affiliation
Ondokuzmayis University, Faculty of Medicine Department of Biochemistry, Samsun, Turkey.
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Selma ELEKDAG TURK, Prof
Organizational Affiliation
Ondokuzmayis University, Faculty of Dentistry, Department of Orthodontics, Samsun, Turkey.
Official's Role
Study Chair
Facility Information:
Facility Name
Ondokuz Mayıs University, Faculty of Dentistry, Department of Periodontology
City
Samsun
ZIP/Postal Code
55270
Country
Turkey

12. IPD Sharing Statement

Plan to Share IPD
No

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Impacts of Oral Irrigation in Orthodontic Patients

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