An Early Phase 1 interventional study of Salvadora Persica Root and Toothbrushing in Stage II or Stage III Grade B Periodontitis, sponsored by Cairo University. Not yet recruiting at 1 site in Egypt. Open to participants aged 20 Years to 60 Years. Per ClinicalTrials.gov, last updated 2026-05-20.
Sponsored by Cairo University · Early Phase 1, Interventional, and Treatment
The study is conducted to evaluate the invitro effect of Salvadora persica (miswak) extract on periodontal fibroblasts production of matrix metalloproteinase-9 (MMP-9) and prostaglandin E2 (PGE2) and correlating the results to clinical outcomes and biomarkers by assessing the MMP-9 and PGE2 levels in gingival crevicular fluid by a randomized controlled clinical trial comparing the use of toothbrush as the control group with miswak chewing stick as a substitute to personal mechanical plaque control in patients with stage II or III grade B periodontitis.
Despite the clinical benefits mentioned, miswak use have been associated with some drawbacks such as clinical attachment loss; improper use of miswak over a long period can result in a risk of oral tissues injury. To date, there is a lack of comprehensive evidence-based literature to guide a safe and effective accepted practice that can subsequently be used as oral hygiene instructions for miswak users. Correlation between the in vitro and in vivo findings will be performed to evaluate the translational relationship between the effects of miswak on periodontal fibroblast inflammatory activity and the corresponding clinical and biomarker outcomes in patients with periodontitis. Matrix metalloproteinase-9 (MMP-9) and prostaglandin E2 (PGE2) levels obtained from periodontal fibroblast cultures will be compared with gingival crevicular fluid (GCF) MMP-9 and PGE2 levels and clinical periodontal parameters, including probing depth (PD), clinical attachment level (CAL), bleeding on probing (BOP), and plaque index (PI).
Cairo University is the lead sponsor of 4,780 studies on the registry; 1,427 are open to participants now.
Of its 36 completed or terminated interventional studies of FDA-regulated products, 5 (14%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Have poor manual dexterity
The test group that will be assigned to use miswak chewing sticks for personal plaque
Behavioral: Salvadora Persica Root
The control group that will be assigned to use the toothbrush for personal plaque
Behavioral: Toothbrushing
Miswak chewing sticks will be used as an alternative to the toothbrush
Modified Bass technique will be employed
Matrix metalloproteinase-9 (MMP-9) level in gingival crevicular fluid (GCF)
GCF will be collected at baseline and after 3 months to assess the MMP-9 level change by ELISA kit
Time frame: 3 months
Plan to share: No
No publications or documents are linked to this record.
This study is not yet recruiting, as verified in May 2026. You cannot join it, but the record below documents what was studied.
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Cairo University