Efficacy of Resveratrol Containing Mouthwash in Reducing Halitosis Related Porphyrymonas Gingivalis.
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age20-24
SponsorAl-Mustansiriyah University
About this trial
The aim of the study:
To assess the efficacy of antioxidant (resveratrol) mouthwash in reducing the level of p. gingivitis and oral malodor over 7 day period among undergraduate dental student patients from Mustansiriyah University/College of Dentistry and Wasit University /College of Dentistry.
Objectives:
* To assess the efficacy of anti-oxidant and anti-inflammatory resveratrol mouthwash in reducing halitosis in undergraduate students with plaque-induced gingivitis patients. * To assess the efficacy of resveratrol mouthwash in reducing p. gingivalis in undergraduate students' patients with oral malodor. * To determine the relation between p.gingivalis and clinical periodontal parameters (plaque index, gingival index, bleeding on probing) among undergraduate students with plaque-induced gingivitis and halitosis.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Organoleptic tongue of scores > 2 using (0-5scale) (Rosenberg and McCulloch, 1992)
Male and female undergraduate dental students without chemical plaque control measures for at least one weak
Male and female students with halitosis due to gingivitis
The age of students ranges from 20 to 23 years.
Disqualifiers
Smokers and alcoholics
Patient with periodontitis or pocket depth > 6mm
Patient with orthodontics appliance
Open carious lesions, pericoronitis, dry socket, and fistula.
Trial design
Design model
Parallel
Treatments tested in this trial
resveratrol mouthwash
Drugthe participants where instruct to rinse their mouth twice daily with 10 ml of assigned mouthwash for 60 seconds for 7 days. There is currently no published research on the use of resveratrol as a mouthwash for halitosis treatment. This study aims to fill this gap by evaluating its effectiveness in reducing oral malodor through antibacterial action and the potential of volatile sulfur compounds ( VSCs)
Chlorhexidine mouthwash (0.2%)
DrugThe second group will given chlorhexidine 0.2% mouthwash as an active comparator, and will asked to rinse with 10 ml of undiluted mouthwash for 60 seconds twice per day for 7 days, and will instructed to refrain from eating and drinking for 30 min after rinsing.
Placebo
Drugthe third group will given the nonactive control, distilled water, and will be asked to rinse with 10 ml of undiluted mouthwash for 60 seconds twice daily for 7 days and will be instructed to refrain from eating and drinking for 30 min after rinsing.
Treatment groups
54 Participants
are divided into 3 treatment groupsGroup A: Resveratrol group ( group A )Experimental treatment 1 intervention
Group B: Chlorhexidine group ( group B)Active comparator 1 intervention
Group C: placebo group ( group C)Placebo comparator 1 intervention
Trial outcomes
Primary outcomes
1
change in oral halitosis (oral malodor)
change in volatile sulfur compounds(VSCs) levels measured by organoleptic method and portable monitor( Halimeter), change in p.gingivalis count using real-time PCR. the participants will be subjected to organoleptic measurement to detect the patient with halitosis according to organoleptic categories. A portable sulfide monitor will be use to confirm the result of organoleptic method, a
Time frame
Baseline (Day 0) and after 7 days2
change in clinical periodontal parameters ( gingival index)
GI will be measured by using Löe and Silness index, each of the four gingival areas of the tooth is given a score from 0 to 3 as follows: 0 Normal gingiva, 1. Mild inflammation slight change in color, slight oedema 2. Moderate inflammation-redness, oedema and glazing. 3. Severe inflammation marked redness and oedema. Ulceration. Tendency to spontaneous bleeding s
Time frame
Baseline (Day 0) and after 7 days3
change in clinical periodontal parameters (plaque index)
The plaque index will be measured by using the O'Leary plaque index. By recording the presence of plaque on (mesial, distal, facial, lingual) surfaces, A disclosing solution will painted on all exposed tooth surfaces at the initial appointment. The examiner will use an explorer or probe tip to examine all the stained surface for dental biofilm. After all teeth were examined and scored, the mean was calculated by dividing the number of plaque surfaces by the total number of available surfaces multiplied by 100%. (O'Leary et al., 1972).
Time frame
Baseline (Day 0) and after 7 days4
change in clinical periodontal parameters (bleeding on probing)
Bleeding on Probing will be measured by gently inserting the periodontal probe at the six surfaces of all teeth to the depth of the gingival sulcus then removed coronally and waited for 30 seconds to observe the presence or absence of bleeding (0=no bleeding, 1=presence of bleeding). (Newman MG., 2011)
Time frame
Baseline (Day 0) and after 7 daysSponsors and contacts
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Source ClinicalTrials.gov