Impacts of Oral Irrigation in Patients With Periimplant Mucositis

NCT ID: NCT03844035

Last Updated: 2019-02-18

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 45 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-11-06
• Study Completion Date: 2015-06-05

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 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.

Conditions

Peri-implant Mucositis

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(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.

Group Type: EXPERIMENTAL

Periimplant crevicular fluid (PICF) collection

Intervention Type: DIAGNOSTIC_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.

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 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.

Group Type: EXPERIMENTAL

Periimplant crevicular fluid (PICF) collection

Intervention Type: DIAGNOSTIC_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.

Control group

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.

Group Type: ACTIVE_COMPARATOR

Periimplant crevicular fluid (PICF) collection

Intervention Type: DIAGNOSTIC_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.

Interventions

Periimplant crevicular fluid (PICF) collection

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.

Intervention Type: DIAGNOSTIC_TEST

Eligibility Criteria

Inclusion Criteria

• 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

Exclusion Criteria

• 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

• Minimum Eligible Age: 45 Years
• Maximum Eligible Age: 60 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,

Sema TUTUNCUOGLU, Dr

Role: PRINCIPAL_INVESTIGATOR

Samsun Oral and Dental Health Hospital, Samsun, Turkey

Ferda PAMUK, Assoc. Prof.

Role: STUDY_CHAIR

Beykent University, Faculty of Dentistry, Department of Periodontology

Bahattin AVCI, Assoc. Prof.

Role: STUDY_CHAIR

Ondokuzmayis University, Faculty of Medicine Department of Biochemistry

Gonca Cayir KELES, Prof

Role: STUDY_CHAIR

Okan University, Faculty of Dentistry, Department of Periodontology

Muge LUTFIOGLU, Assoc. Prof.

Role: STUDY_CHAIR

Ondokuzmayis University, Faculty of Dentistry, Department of Periodontology

Şevki GULER, Assist.Prof.

Role: STUDY_CHAIR

Izzet Baysal University, Faculty of Dentistry, Department of Periodontology

References

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.

Reference Type: DERIVED

PMID: 34251534 (View on PubMed)

Other Identifiers

B.30.2.ODM.0.20.08/1034

Identifier Type: -

Identifier Source: org_study_id