Back to resultsChios Mastic Mouthwash and Halitosis and Oral Hygiene in Orthodontic Patients
Primary Purpose
Halitosis, Orthodontic Appliance Complication
Status
Completed
Phase
Not Applicable
Locations
Greece
Study Type
Interventional
Intervention
Mastic mouthwash
Placebo mouthwash
Sponsored by
About this trial
This is an interventional prevention trial for Halitosis focused on measuring Halitosis, Mastic, Orthodontic appliance
Eligibility Criteria
Inclusion Criteria: Patients eligible for the trial must comply with all of the following at randomization: • Age between 13 and 18 years for the group with conventional orthodontic appliances. This age group represents the majority of patients seeking orthodontic treatment and is homogeneous regarding occupational status (high-school and lyceum students in Greece). Younger patients might present with cooperation problems. Good general health. Orthodontic fixed labial appliances on the maxillary and mandibular arch, brackets at least on 20 teeth for more than 4 months before enrollment and estimated duration of the treatment more than 1 month, bands on the first molars, extraction cases patients could be enrolled at least two months after the last extraction. Total initial VSCs levels above the baseline level of 150ppb. Exclusion Criteria: Patients will be excluded for any of the following reasons: Active caries Periodontitis Dental fluorosis / dysplasia of the teeth Syndromes, mental disabilities and craniofacial deformities Smoking or use of other tobacco products Allergy to mastic Antibiotics during the last 2 months Chlorhexidine in the previous 3 weeks Participation in other trials
Sites / Locations
- National and Kapodistrian University of Athens, School of Dentistry, Departments of Orthodontics
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Experimental: Group 1
Control group: Group 2
Arm Description
Experimental: Experimental group 1: patients, age 13-18, conventional brackets, Mastic mouthwash 15 patients, age 13-18,with conventional brackets,will get Mastic mouthwash
Control group: Group 2 patients, age 13-18, conventional brackets, placebo mouthwash 15 patients, age 13-18,with conventional brackets,will get placebo mouthwash
Outcomes
Primary Outcome Measures
Modified plaque index (PI-M)
The Silness and Löe index (Silness and Löe, 1964) does not take into account the pattern of plaque accumulation in orthodontic patients. To overcome this problem, Williams et al. (1991) divided the tooth into mesial, distal, gingival, and incisal regions in relation to the bracket and scored plaque in each region using the four codes of the original index (0 to 3). The values are summed to obtain a total score, which ranges from 0 to 12 for each tooth. This modified index is recommended for patients with fixed orthodontic appliances because it acknowledges the usual effects of orthodontic appliances on plaque distribution and has much greater categorical discrimination.
Gingival index (GI)
The Gingival Index (GI) is a measure of the severity of gingivitis and is scored by measuring the amount of gingival inflammation, also considering redness and bleeding (Löe & Silness, 1963).
VSCs levels {hydrogen sulfide (H2S), methyl-mercaptan (CH3SH) and dimethyl sulfide [(CH3)2S].
VSCs levels {hydrogen sulfide (H2S), methyl-mercaptan (CH3SH) and dimethyl sulfide [(CH3)2S]} will be measured with the OralChromaTM device (NOVATRONIC Deutschland GmbH, Kölner Straße 102, D-51429 Bertogisch Gladbach).
The organoleptic evaluation will be done by the patient, due to the current pandemic of the SARS-Covid 19 virus. This assessment will be subjectively based on a scale in printed questionnaires. The objective assessment of the T0-T1 VSCs levels will be done with the OralChromaTM. This chromatograph measured the concentrations of the oral gases H2S, CH3SH and (CH3)2S. The sample will be collected using disposable syringes (1 ml plastic syringes), which will be inserted into the patient's oral cavity. The patients weill be asked to close their mouth for 30 seconds before the samples collection. Then 0.5ml of air will injected from the syringe's intake into the measuring device.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05647369
Brief Title
Chios Mastic Mouthwash and Halitosis and Oral Hygiene in Orthodontic Patients
Official Title
The Effect of Chios Mastic Mouthwash on Halitosis and Oral Hygiene in Orthodontic Patients: a Randomized Clinical Trial
Study Type
Interventional
2. Study Status
Record Verification Date
May 2023
Overall Recruitment Status
Completed
Study Start Date
December 1, 2022 (Actual)
Primary Completion Date
March 1, 2023 (Actual)
Study Completion Date
March 1, 2023 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Iosif Sifakakis
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
Halitosis is the third most common oral condition perceived by the patients as pathologic, after caries and periodontal diseases. Although it is difficult to estimate the prevalence of halitosis in the population due to the different assessment methods, the available descriptive epidemiologic studies estimate that 30-50% of the population experience oral malodor. Pathologic halitosis most commonly (85%) originates from the oral cavity and is a result of bacterial deposits that cover the tongue or are found in the inflamed oral mucosa, under poor-quality restorations, orthodontic mechanisms, carious lesions or mucosal ulcers. Odor usually results from the microbial degradation of organic substrates present in saliva. This interaction generates malodorous volatile sulfur compounds (VSCs), of which the three most common are: hydrogen sulfide (H2S), methyl-mercaptan (CH3SH) and dimethyl sulfide [(CH3)2S].
Orthodontic patients with fixed appliances are more prone to halitosis, due to the increased plaque accumulation and the increased amounts of available nutrients for the supragingival and subgingival microbes .
Detailed Description
AIM: The aim of this study is to investigate the effect of Mastic mouthwash on halitosis (Volatile Sulfur Compounds' levels, VSCs) as well as plaque and gingival indexes in patients undergoing orthodontic treatment with fixed appliances PARTICIPANTS AND METHOD: The study is a double-blinded, placebo-controlled, parallel group, randomized clinical trial. Thirty patients with fixed orthodontic appliances were randomly allocated at a 1:1 ratio, to either the mastic-mouthwash or the placebo-mouthwash group. Eligibility criteria included ages between 13 and 18, active orthodontic treatment with fixed appliances, good general health and total initial VSCs levels above the baseline level of 150ppb. The primary outcomes will be: (a) their subjective perception of their own malodor via questionnaires, (b) their objective VSCs levels (hydrogen sulfide (H2S), methyl-mercaptan (CH3SH) and dimethyl sulfide ((CH3)2S) through the OralChromaTM device and (c) oral hygiene assessed with the use of the Modified Silness and Löe Plaque Index (PI-M) and the Silness and Löe Gingival Index (GI). Measurements were taken at baseline (T0) and after 2 weeks (T1).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Halitosis, Orthodontic Appliance Complication
Keywords
Halitosis, Mastic, Orthodontic appliance
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
This trial is designed as a prospective, randomized, placebo-controlled, double (investigator and patient) blinded, with two parallel groups and an equal allocation ratio in all groups. In this study, the intervention consists of delivery of mastic mouthwash or placebo lozenges.
Masking
ParticipantInvestigator
Masking Description
All patients will be allocated at a 1:1 ratio between group A (mastic group) and group B (placebo group), for each sex separately using stratified randomization. Two random sequences of 15 letters (A or B) will be obtained from www.random.org (List Randomizer service), one for males and one for females. Those letters were written on paper and then sealed in opaque envelopes, sequentially numbered from M1 to M15 for males and from F1 to F15 for females respectively. All envelopes were sealed, numbered and stored in a drawer by a person not involved in the study. Every patient enrolled in the study will receive an envelope in a numerical order and their name was written on the envelope. Informed consent will be obtained from parents / legal guardians and written consent upon information and prior to the randomization or application of any procedure obtained from the patients.
Allocation
Randomized
Enrollment
30 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Experimental: Group 1
Arm Type
Experimental
Arm Description
Experimental: Experimental group 1: patients, age 13-18, conventional brackets, Mastic mouthwash 15 patients, age 13-18,with conventional brackets,will get Mastic mouthwash
Arm Title
Control group: Group 2
Arm Type
Placebo Comparator
Arm Description
Control group: Group 2 patients, age 13-18, conventional brackets, placebo mouthwash 15 patients, age 13-18,with conventional brackets,will get placebo mouthwash
Intervention Type
Dietary Supplement
Intervention Name(s)
Mastic mouthwash
Intervention Description
All 30 patients will be randomly assigned to either the mastic mouthwash group A (Art of Nature Mastiha Mouthwash, Mastihashop, Greece) (n = 15) or the placebo mouthwash group B (from the same manufacturer) (n = 15) (Table 1). All patients will be asked to use the mouthwash twice a day (10 ml of mouthwash / 2 times a day for 30 sec for 14 days, every morning and every night after brushing) and to maintain their usual oral hygiene routine. The measurements will be done in the morning and at least three hours after brushing and without the use of the mouthwash by the participant on the day of the assessments.
Intervention Type
Dietary Supplement
Intervention Name(s)
Placebo mouthwash
Intervention Description
All 30 patients will be randomly assigned to either the mastic mouthwash group A (Art of Nature Mastiha Mouthwash, Mastihashop, Greece) (n = 15) or the placebo mouthwash group B (from the same manufacturer) (n = 15) (Table 1). All patients will be asked to use the mouthwash twice a day (10 ml of mouthwash / 2 times a day for 30 sec for 14 days, every morning and every night after brushing) and to maintain their usual oral hygiene routine. The measurements will be done in the morning and at least three hours after brushing and without the use of the mouthwash by the participant on the day of the assessments.
Primary Outcome Measure Information:
Title
Modified plaque index (PI-M)
Description
The Silness and Löe index (Silness and Löe, 1964) does not take into account the pattern of plaque accumulation in orthodontic patients. To overcome this problem, Williams et al. (1991) divided the tooth into mesial, distal, gingival, and incisal regions in relation to the bracket and scored plaque in each region using the four codes of the original index (0 to 3). The values are summed to obtain a total score, which ranges from 0 to 12 for each tooth. This modified index is recommended for patients with fixed orthodontic appliances because it acknowledges the usual effects of orthodontic appliances on plaque distribution and has much greater categorical discrimination.
Time Frame
baseline-2 weeks
Title
Gingival index (GI)
Description
The Gingival Index (GI) is a measure of the severity of gingivitis and is scored by measuring the amount of gingival inflammation, also considering redness and bleeding (Löe & Silness, 1963).
Time Frame
baseline-2 weeks
Title
VSCs levels {hydrogen sulfide (H2S), methyl-mercaptan (CH3SH) and dimethyl sulfide [(CH3)2S].
Description
VSCs levels {hydrogen sulfide (H2S), methyl-mercaptan (CH3SH) and dimethyl sulfide [(CH3)2S]} will be measured with the OralChromaTM device (NOVATRONIC Deutschland GmbH, Kölner Straße 102, D-51429 Bertogisch Gladbach).
The organoleptic evaluation will be done by the patient, due to the current pandemic of the SARS-Covid 19 virus. This assessment will be subjectively based on a scale in printed questionnaires. The objective assessment of the T0-T1 VSCs levels will be done with the OralChromaTM. This chromatograph measured the concentrations of the oral gases H2S, CH3SH and (CH3)2S. The sample will be collected using disposable syringes (1 ml plastic syringes), which will be inserted into the patient's oral cavity. The patients weill be asked to close their mouth for 30 seconds before the samples collection. Then 0.5ml of air will injected from the syringe's intake into the measuring device.
Time Frame
baseline-2 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
13 Years
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Patients eligible for the trial must comply with all of the following at randomization:
• Age between 13 and 18 years for the group with conventional orthodontic appliances.
This age group represents the majority of patients seeking orthodontic treatment and is homogeneous regarding occupational status (high-school and lyceum students in Greece). Younger patients might present with cooperation problems.
Good general health.
Orthodontic fixed labial appliances on the maxillary and mandibular arch, brackets at least on 20 teeth for more than 4 months before enrollment and estimated duration of the treatment more than 1 month, bands on the first molars, extraction cases patients could be enrolled at least two months after the last extraction.
Total initial VSCs levels above the baseline level of 150ppb.
Exclusion Criteria:
Patients will be excluded for any of the following reasons:
Active caries
Periodontitis
Dental fluorosis / dysplasia of the teeth
Syndromes, mental disabilities and craniofacial deformities
Smoking or use of other tobacco products
Allergy to mastic
Antibiotics during the last 2 months
Chlorhexidine in the previous 3 weeks
Participation in other trials
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Iosif Sifakakis, Assistant Professor
Organizational Affiliation
University of Athens
Official's Role
Principal Investigator
Facility Information:
Facility Name
National and Kapodistrian University of Athens, School of Dentistry, Departments of Orthodontics
City
Athens
State/Province
Attiki
ZIP/Postal Code
11527
Country
Greece
12. IPD Sharing Statement
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Chios Mastic Mouthwash and Halitosis and Oral Hygiene in Orthodontic Patients
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