Peri-implant MucositisNCT03844035
Impacts of Oral Irrigation in Patients With Periimplant Mucositis
A study testing Periimplant crevicular fluid (PICF) collection in people with Peri-implant Mucositis, run by Ondokuz Mayıs University.
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 TGF-β1, IL-1β, t-PA, and PAI-1 levels in periimplant crevicular fluid of patients with periimplant mucositis. Read more about this study
- Who is it for?
- Ages 45 to 60 years
- Conditions the study is for
- Peri-implant Mucositis
- What is being tested?
- Periimplant crevicular fluid (PICF) collection
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- No sites listed yet
- Study dates
- 6 Nov 2014to 5 Jun 2015
- 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 45 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- subject with no systemic diseases that affect oral tissues and the nature of plaque,
- with no professional cleaning for at least six months prior to baseline examination,
- with one or more implants (Straumann, Waldenburg, Switzerland) functioning at least 24 months before the start of the study
- having implants with BOP in at least two of the six regions
- The people who agreed to refrain from the use of any nonstudy dental device or oral care product for the study duration were included in the study
Who cannot join
- subjects not cooperative,
- having disease associated with bacteremia,
- taking medication influencing gingival health (eg. dilantin, calcium channel blockers, cyclosporine, anticoagulants),
- using long-term antibiotic and anti-inflammatory agents,
- smokers and
- women who were pregnant and in lactation period
About this study
Official title: Clinical and Biochemical Evaluation of Oral Irrigation in Patients With Periimplant Mucositis
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 TGF-β1, IL-1β, t-PA, and PAI-1 levels in periimplant crevicular fluid of patients with periimplant mucositis. The null hypothesis was that oral irrigators would be effective compared to interdental brush in the oral care of individuals who use implant-supported protheses.
Read the detailed description
Detailed Description: Our aim was to evaluate efficacy of a manual tooth-brush with either interdental brush or oral irrigator in treatment of periimplant mucositis.
Material and Method: Forty-five patients with periimplant mucositis having at least one implant (age range:45-60) were included in study. Study was planned as randomized, single-blind, parallel-design. Patients were divided into 3 equal groups; i)toothbrush+oral irrigator ii)toothbrush+interdental brush, iii)only toothbrush. 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. Periimplant crevicular fluid(PCF) were taken from patents to assess levels of interleukin-1beta(IL-1β), Transforming growth factor-beta(TGF- β), tissue-type plasminogen activator(t-PA), plasminogen activator inhibitor-1(PAI-1). Clinical records were repeated at 2, 4 and 12 weeks.
The hypothesis of our study is that oral irrigators may be effective in oral care of individuals using an implant-supported prosthesis because of the ease of use.
- Conditions
- Peri-implant Mucositis
- Being tested
- Periimplant crevicular fluid (PICF) collection
- Keywords
- periimplant mucositis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Periimplant crevicular fluid (PICF) collectionDiagnostic test
Prior to PICF 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, New York, 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 PICF 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 -80⁰C. 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(oxytet oral irrigatör).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 and with plastic probe around the implants. All clinical parameters were evaluated on each of the six regions of the implant (mesio-buccal, mid-buccal, disto-buccal, mesio-lingual, mid-lingual, disto-lingual).PICF was collected one day after the clinical examination from buccal aspects of the mesial and distal surfaces at the interproximal sites.Following the initial clinical records, all patients were performed full mouth instrumentation and described oral hygiene procedure according to their groups. Receives: Diagnostic Test: Periimplant crevicular fluid (PICF) 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 and with plastic probe around the implants. All clinical parameters were evaluated on each of the six regions of the implant (mesio-buccal, mid-buccal, disto-buccal, mesio-lingual, mid-lingual, disto-lingual). PICF was collected one day after the clinical examination from buccal aspects of the mesial and distal surfaces at the interproximal sites. Following the initial clinical records, all patients were performed full mouth instrumentation and described oral hygiene procedure according to their groups. Receives: Diagnostic Test: Periimplant crevicular fluid (PICF) collection |
| Control group | Active comparator | Fifteen patients using only toothbrush.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 and with plastic probe around the implants. All clinical parameters were evaluated on each of the six regions of the implant (mesio-buccal, mid-buccal, disto-buccal, mesio-lingual, mid-lingual, disto-lingual). PICF was collected one day after the clinical examination from buccal aspects of the mesial and distal surfaces at the interproximal sites. Following the initial clinical records, all patients were performed full mouth instrumentation and described oral hygiene procedure according to their groups. Receives: Diagnostic Test: Periimplant crevicular fluid (PICF) collection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Periimplant crevicular fluid level of IL-1β as a marker of gingival inflammation
Elevated levels of IL-1β in periimplant crevicular fluid have been associated with the destructive changes that occur in the inflamed human gingiva
Measured: through study completion, an average of 1 year
Periimplant crevicular fluid level of TGF-β1 as a marker both of inflammatory phase and proliferative phase
TGF-β1 plays a role in the development and progression of periodontal diseases.
Measured: through study completion, an average of 1 year
Periimplant crevicular fluid level of t-PA as a marker for clinical evaluation and efficacy of periodontal treatment
Higher levels of t-PA in periimplant crevicular fluid have been associated with gingivitis and periodontitis.
Measured: through study completion, an average of 1 year
Periimplant crevicular fluid level of PAI-1 as a marker for clinical evaluation and efficacy of periodontal treatment
Higher levels of PAI-1 may be associated with progression of periodontitis
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 posted18 Feb 2019
- Study start6 Nov 2014
- Primary completion4 May 2015
- Study completion5 Jun 2015
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 Peri-implant MucositisStudies 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
- Forty-five patients with periimplant mucositis having at least one implant (age range:45-60) were included in study. Study was planned as randomized, single-blind, parallel-design. Patients were divided into 3 equal groups; i)toothbrush+oral irrigator ii)toothbrush+interdental brush, iii)only toothbrush. 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. Periimplant crevicular fluid(PCF) were taken from patents to assess levels of interleukin-1beta(IL-1β), Transforming growth factor-beta(TGF- β), tissue-type plasminogen activator(t-PA), plasminogen activator inhibitor-1(PAI-1). Clinical records were repeated at 2, 4 and 12 weeks.
- Masking
- None (open label)
- Enrolment
- 45 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,Sema TUTUNCUOGLU, Dr, Principal investigator, Samsun Oral and Dental Health Hospital, Samsun, TurkeyFerda PAMUK, Assoc. Prof., Study chair, Beykent University, Faculty of Dentistry, Department of PeriodontologyBahattin AVCI, Assoc. Prof., Study chair, Ondokuzmayis University, Faculty of Medicine Department of BiochemistryGonca Cayir KELES, Prof, Study chair, Okan University, Faculty of Dentistry, Department of PeriodontologyMuge LUTFIOGLU, Assoc. Prof., Study chair, Ondokuzmayis University, Faculty of Dentistry, Department of PeriodontologyŞevki GULER, Assist.Prof., Study chair, Izzet Baysal University, Faculty of Dentistry, Department of Periodontology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03844035
- Sponsor's protocol ID
- B.30.2.ODM.0.20.08/1034
- Status last verified
- Feb 2019
- First submitted
- 6 Feb 2019
- Last updated
- 18 Feb 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Tutuncuoglu S, Cetinkaya BO, Pamuk F, Avci B, Keles GC, Kurt-Bayrakdar S, Lutfioglu M. Clinical and biochemical evaluation of oral irrigation in patients with peri-implant mucositis: a randomized clinical trial. Clin Oral Investig. 2022 Jan;26(1):659-671. doi: 10.1007/s00784-021-04044-x. Epub 2021 Jul 12.
PubMed 34251534
Study at a glance
From the registry record, last updated by the sponsor on 18 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical and Biochemical Evaluation of Oral Irrigation in Patients With Periimplant Mucositis
- ClinicalTrials.gov ID
- NCT03844035
- Acronym / sponsor ID
- B.30.2.ODM.0.20.08/1034
- Conditions
- Peri-implant Mucositis
- Keywords
- periimplant mucositis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- Ondokuz Mayıs UniversityUniversity, hospital or other
- Study start
- 6 Nov 2014 (actual)
- Primary completion
- 4 May 2015 (actual)
- Study completion
- 5 Jun 2015 (actual)
- First posted
- 18 Feb 2019 (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 TGF-β1, IL-1β, t-PA, and PAI-1 levels in periimplant crevicular fluid of patients with periimplant mucositis. The null hypothesis was that oral irrigators would be effective compared to interdental brush in the oral care of individuals who use implant-supported protheses.
Detailed description
Detailed Description: Our aim was to evaluate efficacy of a manual tooth-brush with either interdental brush or oral irrigator in treatment of periimplant mucositis.
Material and Method: Forty-five patients with periimplant mucositis having at least one implant (age range:45-60) were included in study. Study was planned as randomized, single-blind, parallel-design. Patients were divided into 3 equal groups; i)toothbrush+oral irrigator ii)toothbrush+interdental brush, iii)only toothbrush. 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. Periimplant crevicular fluid(PCF) were taken from patents to assess levels of interleukin-1beta(IL-1β), Transforming growth factor-beta(TGF- β), tissue-type plasminogen activator(t-PA), plasminogen activator inhibitor-1(PAI-1). Clinical records were repeated at 2, 4 and 12 weeks.
The hypothesis of our study is that oral irrigators may be effective in oral care of individuals using an implant-supported prosthesis because of the ease of use.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- Forty-five patients with periimplant mucositis having at least one implant (age range:45-60) were included in study. Study was planned as randomized, single-blind, parallel-design. Patients were divided into 3 equal groups; i)toothbrush+oral irrigator ii)toothbrush+interdental brush, iii)only toothbrush. 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. Periimplant crevicular fluid(PCF) were taken from patents to assess levels of interleukin-1beta(IL-1β), Transforming growth factor-beta(TGF- β), tissue-type plasminogen activator(t-PA), plasminogen activator inhibitor-1(PAI-1). Clinical records were repeated at 2, 4 and 12 weeks.
| Arm | Type | Receives |
|---|---|---|
| Oral irrigator group | Experimental | Diagnostic Test: Periimplant crevicular fluid (PICF) collectionFifteen patients using toothbrush and oral irrigator(oxytet oral irrigatör).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 and with plastic probe around the implants. All clinical parameters were evaluated on each of the six regions of the implant (mesio-buccal, mid-buccal, disto-buccal, mesio-lingual, mid-lingual, disto-lingual).PICF was collected one day after the clinical examination from buccal aspects of the mesial and distal surfaces at the interproximal sites.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: Periimplant crevicular fluid (PICF) 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 and with plastic probe around the implants. All clinical parameters were evaluated on each of the six regions of the implant (mesio-buccal, mid-buccal, disto-buccal, mesio-lingual, mid-lingual, disto-lingual). PICF was collected one day after the clinical examination from buccal aspects of the mesial and distal surfaces at the interproximal sites. Following the initial clinical records, all patients were performed full mouth instrumentation and described oral hygiene procedure according to their groups. |
| Control group | Active comparator | Diagnostic Test: Periimplant crevicular fluid (PICF) collectionFifteen patients using only toothbrush.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 and with plastic probe around the implants. All clinical parameters were evaluated on each of the six regions of the implant (mesio-buccal, mid-buccal, disto-buccal, mesio-lingual, mid-lingual, disto-lingual). PICF was collected one day after the clinical examination from buccal aspects of the mesial and distal surfaces at the interproximal sites. 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
- 45 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- subject with no systemic diseases that affect oral tissues and the nature of plaque,
- with no professional cleaning for at least six months prior to baseline examination,
- with one or more implants (Straumann, Waldenburg, Switzerland) functioning at least 24 months before the start of the study
- having implants with BOP in at least two of the six regions
- The people who agreed to refrain from the use of any nonstudy dental device or oral care product for the study duration were included in the study
Key exclusion criteria (6 listed)
- subjects not cooperative,
- having disease associated with bacteremia,
- taking medication influencing gingival health (eg. dilantin, calcium channel blockers, cyclosporine, anticoagulants),
- using long-term antibiotic and anti-inflammatory agents,
- smokers and
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 |
|---|---|---|
| Periimplant crevicular fluid (PICF) collectionPrior to PICF 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, New York, 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 PICF 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 -80⁰C. The readings were converted to an actual volume (µl) by reference to the standard curve. | Diagnostic test | Control group, Interdental brush group, Oral irrigator group |
Primary outcome
Periimplant 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 periimplant crevicular fluid have been associated with the destructive changes that occur in the inflamed human gingiva
Periimplant crevicular fluid level of TGF-β1 as a marker both of inflammatory phase and proliferative phase
Time frame: through study completion, an average of 1 year
TGF-β1 plays a role in the development and progression of periodontal diseases.
Periimplant crevicular fluid level of t-PA as a marker for clinical evaluation and efficacy of periodontal treatment
Time frame: through study completion, an average of 1 year
Higher levels of t-PA in periimplant crevicular fluid have been associated with gingivitis and periodontitis.
Periimplant crevicular fluid level of PAI-1 as a marker for clinical evaluation and efficacy of periodontal treatment
Time frame: through study completion, an average of 1 year
Higher levels of PAI-1 may be associated with progression of periodontitis
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 18 Feb 2019.
- Derived from this study: PubMed 34251534Tutuncuoglu S, Cetinkaya BO, Pamuk F, Avci B, Keles GC, Kurt-Bayrakdar S, Lutfioglu M. Clinical and biochemical evaluation of oral irrigation in patients with peri-implant mucositis: a randomized clinical trial. Clin Oral Investig. 2022 Jan;26(1):659-671. doi: 10.1007/s00784-021-04044-x. Epub 2021 Jul 12.
- 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,
Sema TUTUNCUOGLU, Dr principal investigator
Samsun Oral and Dental Health Hospital, Samsun, Turkey
Ferda PAMUK, Assoc. Prof. study chair
Beykent University, Faculty of Dentistry, Department of Periodontology
Questions about this trial
What is this clinical trial studying?
A study testing Periimplant crevicular fluid (PICF) collection in people with Peri-implant Mucositis, run by Ondokuz Mayıs University.
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 5 inclusion and 6 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 18 Feb 2019. Status can change between updates, so confirm with the study contact before making plans.
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?
Periimplant 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 NCT03844035, 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 18 Feb 2019.