Impacts of Oral Irrigation in Patients With Periimplant Mucositis

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Primary Purpose

Status

Completed

Phase

Not Applicable

Locations

Study Type

Interventional

Intervention

Periimplant crevicular fluid (PICF) collection

About this trial

This is an interventional prevention trial for Peri-implant Mucositis focused on measuring periimplant mucositis

Eligibility Criteria

45 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

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:

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

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

Arm Label

Oral irrigator group

Interdental brush group

Control group

Arm Description

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.

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.

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.

Outcomes

Primary Outcome Measures

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

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.

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.

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

Secondary Outcome Measures

Full Information

NCT ID

NCT03844035

First Posted

February 6, 2019

Last Updated

February 15, 2019

Sponsor

Ondokuz Mayıs University

1. Study Identification

Unique Protocol Identification Number

NCT03844035

Brief Title

Impacts of Oral Irrigation in Patients With Periimplant Mucositis

Official Title

Clinical and Biochemical Evaluation of Oral Irrigation in Patients With Periimplant Mucositis

Study Type

Interventional

2. Study Status

Record Verification Date

February 2019

Overall Recruitment Status

Completed

Study Start Date

November 6, 2014 (Actual)

Primary Completion Date

May 4, 2015 (Actual)

Study Completion Date

June 5, 2015 (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

Product Manufactured in and Exported from the U.S.

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 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Peri-implant Mucositis

Keywords

periimplant mucositis

7. Study Design

Primary Purpose

Prevention

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

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)

Allocation

Randomized

Enrollment

45 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Oral irrigator group

Arm Type

Experimental

Arm Description

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.

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 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.

Arm Title

Control group

Arm Type

Active Comparator

Arm Description

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.

Intervention Type

Diagnostic Test

Intervention Name(s)

Periimplant crevicular fluid (PICF) collection

Intervention Description

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.

Primary Outcome Measure Information:

Title

Periimplant crevicular fluid level of IL-1β as a marker of gingival inflammation

Description

Elevated levels of IL-1β in periimplant crevicular fluid have been associated with the destructive changes that occur in the inflamed human gingiva

Time Frame

through study completion, an average of 1 year

Title

Periimplant crevicular fluid level of TGF-β1 as a marker both of inflammatory phase and proliferative phase

Description

TGF-β1 plays a role in the development and progression of periodontal diseases.

Time Frame

through study completion, an average of 1 year

Title

Periimplant crevicular fluid level of t-PA as a marker for clinical evaluation and efficacy of periodontal treatment

Description

Higher levels of t-PA in periimplant crevicular fluid have been associated with gingivitis and periodontitis.

Time Frame

through study completion, an average of 1 year

Title

Periimplant crevicular fluid level of PAI-1 as a marker for clinical evaluation and efficacy of periodontal treatment

Description

Higher levels of PAI-1 may be associated with progression of periodontitis

Time Frame

through study completion, an average of 1 year

10. Eligibility

Sex

All

Minimum Age & Unit of Time

45 Years

Maximum Age & Unit of Time

60 Years

Accepts Healthy Volunteers

No

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: 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

Overall Study Officials: