Mustansiriyah University
Baghdad, Iraq
NCT Number: NCT06792812
The study aims to determine ginger mouthwash's impact on gingival health, IL-6, cortisol, LF, and 8-OHdG levels in pregnant women with stress and gingivitis compared to CHX and distilled water.
Objectives:
1. Evaluate the clinical efficiency of ginger mouth rinse for 7 days to control gingival inflammation by measuring the clinical periodontal parameters, Plaque Index (PI), Gingival Index (GI), and Bleeding on probing (BOP) in comparison with CHX and placebo mouth rinses in pregnant women who have stress and gingivitis. 2. Measuring salivary IL_6, Cortisol, LF, and 8-OHdG levels by Enzyme-linked immunosorbent assay (ELISA) at the baseline visit before and after 7 days of using ginger mouth rinse compared to CHX and placebo mouth rinses. 3. Assessment of participants' feedback regarding ginger, CHX, and placebo mouth rinses after 7 days of use by Visual Analog Scale (VAS) questionnaire. 4. correlate IL_6, Cortisol, LF and 8-OHdG salivary levels with clinical periodontal parameters (GI, BOP, PI) to assess their relationship in pregnant women with stress and gingivitis.
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Notify Me20 year–30 year
Female
Interventional
Phase 2
Baghdad, Iraq
54 pregnant with stress will be enrolled, who show with gingivitis The investigator assesses symptoms of stress using a translated Arabic version of Perceived Stress Scale (PSS) Each pregnant answers following questions Questions never almost never sometimes fairly often very often
For each question choose from the following alternatives:
0 - never 1 - almost never 2 - sometimes 3 - fairly often 4 - very often Individual scores on the PSS can range from 0 to 40 with higher scores indicating higher perceived stress.
A triple-blind, randomized parallel 3-arms clinical trial include using the following mouth rinses, 0.12% CHX (KIN Gingival, KIN, Barcelona, Spain) as positive-control, distilled water (placebo, nonactive control) with food additives (to blind the subjects and examiner) and ginger mouthwash (Pasta del Capitano, Italy)
The examiner will perform randomization for the enrollment patients in 3 groups. Each group will be assigned a letter (A, B, or C) corresponding to the intervention used. Random numbers were generated and used to re-sort the order of the groups and participants (n=54), who will be distributed into designated groups, each group received a similar number of subjects (n=18) , by using a Microsoft Excel random table (Microsoft Office 2021, Microsoft Corporation, USA). Then, coded bottles with the interventions will be delivered to the participants together with instructions for use.
The participants will be asked to rinse with 10 ml of undiluted mouthwash for 60 s twice per day (30 min after tooth brushing) and will be instructed to refrain from eating and drinking for 30 min after rinsing. Discontinuation of the mouthwash will be advised in cases of any allergic reaction. All participants will be received a toothbrush with medium-hardness bristles and a toothpaste, and All participants are instructed to decrease stress by a combination of diaphragmatic breathing and muscle relaxation Saliva collection for IL-6, cortisol, lactoferrin, and 8-OHdG measurement then clinical periodontal parameters examination starting with gingival index designed to assess the severity and quality of gingival inflammation in an individual or population. The gingival inflammation is assessed on the basis of color, consistency and bleeding on probing. A periodontal probe will be runned along the gingival margin. The gingiva surrounding the tooth is assessed at four sites: mesio-facial papilla, facial marginal gingiva, disto-facial papilla and lingual marginal gingiva.
Followed by dryness and wait then measurement of BOP for the six surfaces of all teeth except wisdom teeth through gently inserting the periodontal probe to the depth of the gingival sulcus then removed coronally and waited for 30 s to observe the presence of bleeding (0=no bleeding, 1=presence of bleeding)
Then finally followed by the Plaque Index :
A periodontal probe may be used to confirm the presence of plaque. Scores were recorded on four surfaces; distal, mid, and mesial points on the facial (buccal) and lingual (palatal) aspects. as follows:
0- ne plaque (left blank)
1- plaque present ( recorded)
First visit after 7 days, from the baseline visit. Saliva collection and clinical periodontal parameters scoring (GI, BOP, PI) will be performed again as described at baseline visit. The mouthwash bottles will be retrieved, and the remaining volume will be determining to further evaluate the compliance with mouth rinsing. For the purpose of self-assessment, a visual analog scale (VAS)- score based questionnaire was filled out by each participant at the end of the trial to evaluate the intervention. The questionnaire and method of data interpretation were adopted and modified from a previous study
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
contain Sulfetal Zn® (Zinc Coco Sulphate) has a cleansing and antibacterial action and will be asked to rinse with 10 ml of undiluted mouthwash for 60 s twice per day (30 min after tooth brushing) and will be instructed to refrain from eating and drinking for 30 min after rinsing. participants will be received a toothbrush with medium-hardness bristles and a toothpaste (COLGATE)and all participants are instructed to decrease stress by a combination of diaphragmatic breathing and muscle relaxation. No modifications to the participants' tooth brushing technique will be permitted. Next, the participants will be re-evaluated after 7 days.
Subjects will then be given Chlorhexidine 0.12%mouthwash, as an active comparator, and will be asked to rinse with 10 ml of undiluted mouthwash for 60 s twice per day (30 min after tooth brushing) and will be instructed to refrain from eating and drinking for 30 min after rinsing. participants will be received a toothbrush with medium-hardness bristles and a toothpaste (COLGATE)and all participants are instructed to decrease stress by a combination of diaphragmatic breathing and muscle relaxation. No modifications to the participants' tooth brushing technique will be permitted. Next, the participants will be re-evaluated after 7 days.
Subjects will be given the nonactive control, distilled water, and will be asked to rinse with 10 ml of undiluted mouthwash for 60 s twice per day (30 min after tooth brushing) and will be instructed to refrain from eating and drinking for 30 min after rinsing. participants will be received a toothbrush with medium-hardness bristles and a toothpaste (COLGATE)and all participants are instructed to decrease stress by a combination of diaphragmatic breathing and muscle relaxation. No modifications to the participants' tooth brushing technique will be permitted. Next, the participants will be re-evaluated after 7 days.
Time frame: 0-7 days
Measuring Change in the clinical periodontal parameter (Bleeding on Probing) Subjects will undergo the measurement bleeding on probing for the six surfaces of all teeth except wisdom teeth through gently inserting the periodontal probe to the depth of the gingival sulcus then removed coronally and waited for 30 s to observe the presence of bleeding (0=no bleeding, 1=presence of bleeding).
Time frame: 0-7 days
Measurement changes in salivary Interleukin 6 by using Enzyme-linked immunosorbent assay (ELISA) before and after using mouthwash by saliva collection before and after using mouthwash Sensitivity 0.94 pg/mL Detection Range 1.56-100 pg/mL
Al-Mustansiriyah University
Other
The Impact of Ginger Mouthwash on the Pregnant Women With Stress and Gingivitis by Measuring Different Salivary Biomarkers Levels (Randomized Clinical Trial)
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