Oral HygieneNCT05562986
Impacts of Oral Irrigation in Orthodontic Patients
A study testing GCF (gingival crevicular fluid) collection in people with Oral Hygiene and Orthodontics, run by Ondokuz Mayıs University at 1 site in Turkey (Türkiye).
Trial 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… Read more about this study
- Who is it for?
- Ages 12 years and older
- Conditions the study is for
- Oral Hygiene, Orthodontics, Periodontal Diseases
- What is being tested?
- GCF (gingival crevicular fluid) collection
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Mar 2018to 27 Dec 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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.
Show all 9Show fewer
- 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.
Who cannot join
- 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).
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Ondokuz Mayıs University, Faculty of Dentistry, Department of Periodontology
Samsun, 55270
About this study
Official title: Clinical and Biochemical Evaluation Oral Irrigator Effectiveness in Patients Under Orthodontic Treatment
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.
Read the 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
- Being tested
- GCF (gingival crevicular fluid) collection
- Keywords
- Cytokine(s), Matrix metalloproteinase(s), Orthodontics, Oral hygiene
- Medical subject headings
- Periodontal Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GCF (gingival crevicular fluid) collectionDiagnostic 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.
| Study group | Role | What they receive |
|---|---|---|
| Oral irrigator group | Experimental | 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. Receives: Diagnostic Test: GCF (gingival crevicular fluid) collection |
| Interdental brush group | Experimental | 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. Receives: Diagnostic Test: GCF (gingival crevicular fluid) collection |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: through study completion, an average of 1 year
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.
Measured: through study completion, an average of 1 year
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.
Measured: through study completion, an average of 1 year
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.
Measured: through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Oct 2022
- Study start1 Mar 2018
- Primary completion1 Aug 2018
- Study completion27 Dec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Oral HygieneStudies of the same condition, open and under way.
- More trials run by Ondokuz Mayıs UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ondokuz Mayıs University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Burcu Ozkan Cetinkaya, Ondokuz Mayıs University
- Investigators
- Burcu OZKAN CETINKAYA, Prof, Study director, Ondokuzmayis University, Faculty of Dentistry, Department of Periodontology, Samsun, Turkey.Esma SAHIN, Dr, Principal investigator, Erzurum Public Oral Health Center, Erzurum, Turkey.Bahattin AVCI, Prof, Study chair, Ondokuzmayis University, Faculty of Medicine Department of Biochemistry, Samsun, Turkey.Selma ELEKDAG TURK, Prof, Study chair, Ondokuzmayis University, Faculty of Dentistry, Department of Orthodontics, Samsun, Turkey.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05562986
- Sponsor's protocol ID
- B.30.2.ODM.0.20.08/1352-1377
- Status last verified
- Sep 2022
- First submitted
- 28 Sep 2022
- Last updated
- 3 Oct 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Sahin E, Cetinkaya BO, Avci B, Kurt-Bayrakdar S, Elekdag-Turk S. Clinical and Biochemical Evaluation of Oral Irrigator Effectiveness in Fixed Orthodontic Treatment: A Randomised Clinical Trial. Int J Dent Hyg. 2026 May 12. doi: 10.1111/idh.70087. Online ahead of print.
PubMed 42120952
Study at a glance
From the registry record, last updated by the sponsor on 3 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical and Biochemical Evaluation Oral Irrigator Effectiveness in Patients Under Orthodontic Treatment
- ClinicalTrials.gov ID
- NCT05562986
- Acronym / sponsor ID
- B.30.2.ODM.0.20.08/1352-1377
- Conditions
- Oral Hygiene, Orthodontics, Periodontal Diseases
- Keywords
- Cytokine(s), Matrix metalloproteinase(s), Orthodontics, Oral hygiene
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Ondokuz Mayıs UniversityUniversity, hospital or other
- Study start
- 1 Mar 2018 (actual)
- Primary completion
- 1 Aug 2018 (actual)
- Study completion
- 27 Dec 2018 (actual)
- First posted
- 3 Oct 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Oral irrigator group | Experimental | Diagnostic Test: GCF (gingival crevicular fluid) collectionFifteen 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. |
| Interdental brush group | Experimental | Diagnostic Test: GCF (gingival crevicular fluid) collectionFifteen 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. |
Who may qualify
- Ages
- 12 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (9 listed)
- 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.
Key exclusion criteria (7 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| GCF (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. | Diagnostic test | Interdental brush group, Oral irrigator group |
Primary outcome
GCF (gingival crevicular fluid) level of IL-1β as a marker of gingival inflammation
Time frame: through study completion, an average of 1 year
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
Time frame: through study completion, an average of 1 year
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
Time frame: through study completion, an average of 1 year
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
Time frame: through study completion, an average of 1 year
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Oct 2022.
- Derived from this study: PubMed 42120952Sahin E, Cetinkaya BO, Avci B, Kurt-Bayrakdar S, Elekdag-Turk S. Clinical and Biochemical Evaluation of Oral Irrigator Effectiveness in Fixed Orthodontic Treatment: A Randomised Clinical Trial. Int J Dent Hyg. 2026 May 12. doi: 10.1111/idh.70087. Online ahead of print.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Burcu OZKAN CETINKAYA, Prof study director
Ondokuzmayis University, Faculty of Dentistry, Department of Periodontology, Samsun, Turkey.
Esma SAHIN, Dr principal investigator
Erzurum Public Oral Health Center, Erzurum, Turkey.
Bahattin AVCI, Prof study chair
Ondokuzmayis University, Faculty of Medicine Department of Biochemistry, Samsun, Turkey.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing GCF (gingival crevicular fluid) collection in people with Oral Hygiene and Orthodontics, run by Ondokuz Mayıs University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Oct 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
GCF (gingival crevicular fluid) level of IL-1β as a marker of gingival inflammation (time frame: through study completion, an average of 1 year). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05562986, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Oct 2022.