Ignite Creation Date:
2024-05-06 @ 7:02 PM
Last Modification Date:
2024-10-26 @ 2:59 PM
Study NCT ID:
NCT05870059
Status:
COMPLETED
Last Update Posted:
2023-05-23
First Post:
2023-04-11
Brief Title:
Comparative Evaluation of Propolis Mouthwash With 02 Chlorhexidine Mouthwash in Improving the Periodontitis
Sponsor:
Ziauddin University
Organization:
Ziauddin University
Study Overview
Official Title:
Comparative Evaluation of Propolis Mouthwash With 02 Chlorhexidine Mouthwash in Improving the Periodontitis
Status:
COMPLETED
Status Verified Date:
2023-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The goal of this clinical trial is to compare the efficacy of Propolis mouthwash with 02 Chlorhexidine mouthwash as an adjunct to mechanical therapy in improving the status of periodontal disease in peri-menopausal women
The main question it aims to answer are
Will propolis mouthwash be equal to Chlorhexidine mouthwash in improving the periodontal status of perimenopausal women
Can neopterin be used as an indicator of periodontal disease
Participants will be asked questions about their general health menstrual health and oral health then scaling will be done After that participants will give saliva sample by spitting in a given container Participants will be divided into 2 groups for treatment and each group comprised of 51 participants
Group 1 20 Propolis mouthwash twice a day for 6 weeks Group 2 02 chlorhexidine mouthwash twice a day for 6 weeks
The main question it aims to answer are
Will propolis mouthwash be equal to Chlorhexidine mouthwash in improving the periodontal status of perimenopausal women
Can neopterin be used as an indicator of periodontal disease
Participants will be asked questions about their general health menstrual health and oral health then scaling will be done After that participants will give saliva sample by spitting in a given container Participants will be divided into 2 groups for treatment and each group comprised of 51 participants
Group 1 20 Propolis mouthwash twice a day for 6 weeks Group 2 02 chlorhexidine mouthwash twice a day for 6 weeks
Detailed Description:
Patients who gave consent underwent oral examination and subjects with scores 3 and 4 according to the protocols described by the British Society of Periodontology were recruited into the study
To evaluate the treatment outcome following periodontal parameters were assessed at baseline 6 weeks and 12 weeks
a periodontal pocket depth b clinical attachment loss c bleeding on probing
The development of mouthwash includes 2 steps ie extraction and formulation i Propolis extraction was carried out at the University of Karachi and the propolis collected was authenticated by the Department of Pharmacognosy Faculty of Pharmacy University of Karachi
ii The formulation was done by the Department of Pharmacognosy at Ziauddin College of Pharmacology
After formulations various stability tests were performed on mouthwash to check its safety such as pH Viscosity Bio-burden and skin irritancy test In the end participants were also asked questions to check the acceptability of the product in terms of odour colour taste fragrance application and satisfaction with the outcome by the participants those items that achieved acceptance of 80 or above were considered acceptable
Saliva samples were taken at baseline and 12 weeks and neopterin levels were assessed using ELISA
The correlation between neopterin levels and measures of clinical parameters after the treatment is made to evaluate if neopterin can be used as an indicator of disease progression and treatment outcome
To evaluate the treatment outcome following periodontal parameters were assessed at baseline 6 weeks and 12 weeks
a periodontal pocket depth b clinical attachment loss c bleeding on probing
The development of mouthwash includes 2 steps ie extraction and formulation i Propolis extraction was carried out at the University of Karachi and the propolis collected was authenticated by the Department of Pharmacognosy Faculty of Pharmacy University of Karachi
ii The formulation was done by the Department of Pharmacognosy at Ziauddin College of Pharmacology
After formulations various stability tests were performed on mouthwash to check its safety such as pH Viscosity Bio-burden and skin irritancy test In the end participants were also asked questions to check the acceptability of the product in terms of odour colour taste fragrance application and satisfaction with the outcome by the participants those items that achieved acceptance of 80 or above were considered acceptable
Saliva samples were taken at baseline and 12 weeks and neopterin levels were assessed using ELISA
The correlation between neopterin levels and measures of clinical parameters after the treatment is made to evaluate if neopterin can be used as an indicator of disease progression and treatment outcome
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None