An interventional study of P Flor locally delivered and P Flor systemically administered in Chronic Periodontitis and Probiotics, sponsored by Ziauddin Hospital. Completed at 1 site in Pakistan. Open to participants aged 30 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2019-03-12.
Sponsored by Ziauddin Hospital · Not applicable, Interventional, and Treatment
This study will assess clinical and microbiological efficacy of probiotics and antibiotics in patients of chronic periodontitis as an adjunctive to scaling and root planing (SRP) in reducing bacterial count and in improving clinical periodontal parameters over the period of 12 weeks.Also the comparison between these adjunctives will be made for clinical assessment clinical periodontal parameters will be taken .these parameters plaque index (PI), gingival index (GI), clinical attachment loss (CAL) and pocket probing depth (PPD) for microbiological assessment plaque sample will be taken, DNA will be extracted and then sample will be processed through quantitative polymerase chain reaction (qPCR) for quantitative analysis of bacterial count of porphyromonas gingivalis.
In this clinical trial total 60 participants of clinically diagnosed chronic periodontitis will be recruited after taking a written consent for their approval. Participants will be divided into 3 groups A, B and C through the process of randomization using a method of opaque sealed envelopes. A research assistant will be hired for the purpose of randomization and allocation concealment. All participants will be asked to pick an opaque envelope containing the details of treatment products. After randomization plaque sample will be obtained from the depth of periodontal pockets and all the clinical periodontal parameters will be recorded in every participant. Then all the participants will undergo SRP. After SRP group A will be given antibiotics Amoxicillin 500 milligrams (mg) for 3 times a day (TDS) and Metronidazole 400 milligrams (mg) for twice a day (BD) for 5 days. Group B will be given probiotics lactobacillus reuteri 1.2 billion colony forming unit (CFU) sachets twice daily for swallowing with water for 12 weeks. Group C will be given lactobacillus sachets of same amount and participant will be asked to mix it with little amount of water and apply it on teeth with the toothbrush twice daily after brushing with standard tooth paste for 12 weeks. Patients will be recalled at the interval of 3, 6, 9 and 12 weeks for the recording of clinical periodontal parameters. After completion of trial plaque sample will be taken again from every participant and will be processed through qPCR to check bacterial count of porphyromonas gingivalis before and after treatment. Whereas comparison between clinical periodontal parameters will be made at the interval of 0, 3, 6, 9, 12 weeks.
377 studies on the registry are indexed under Chronic Periodontitis; 21 are open to participants now.
This study's enrollment of 60 is above the median of 46 across 307 interventional studies indexed under Chronic Periodontitis.
Browse Chronic Periodontitis studies →Ziauddin Hospital is the lead sponsor of 4 studies on the registry; 2 are open to participants now.
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Exclusion Criteria:
P Flor (Lactobacillus reuteri 1.2 billion CFU) will be delivered locally every 12 hours for 12 weeks
Dietary Supplement: P Flor locally delivered
P Flor (Lactobacillus reuteri 1.2 billion CFU) will be administered every 12 hours for 12 weeks
Dietary Supplement: P Flor systemically administered
Amoxil 500 mg capsule and Flagyl 400 mg tablet by mouth, will be given every 8 hours for 5 days
Drug: Amoxil 500 mg Oral Capsule · Drug: Flagyl 400 mg Tablet
Locally delivered Lactobacillus reuteri 1.2 CFU per gram
Systemically administered Lactobacillus reuteri 1.2 CFU per gram
Systemically administered Amoxil 500 mg thrice daily
Systemically administered Metronidazole 400 mg twice daily
Change in periodontal pocket depth (PPD)
It is the distance from tip of free gingival margin to the base of pocket
Time frame: Baseline, 3, 6, 9 and 12 weeks
Change in clinical attachment level (CAL)
It is the distance from cementoenamel junction to the base of the pocket around the tooth
Time frame: Baseline, 3, 6, 9 and 12 weeks
Change in bacterial load of Porphyromonas gingivalis
Bacterial count or the quantity of porphyromonas gingivalis in the sample
Time frame: Baseline and 12 weeks after completion of trial
Change in the Plaque index (PI)
How much surface of tooth is covered by the plaque will be recorded.
Time frame: Baseline, 3, 6, 9 and 12 weeks
Change in Gingival index (GI)
Gingival color texture and inflammation will be recorded.
Time frame: Baseline, 3, 6, 9 and 12 weeks
Plan to share: Undecided
No publications or documents are linked to this record.
Ran from Nov 2017 to primary completion in Sep 2018, 10 months.
Of 88 non-industry interventional studies with no phase under Chronic Periodontitis, half reached primary completion within 15 months of starting (the median), counting those still running; a quarter within 10 and three quarters within 24. This study's 10 months is below that.
Counting every sponsor, half of 89 studies reached it within 15 months; a quarter within 10 and three quarters within 24.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Mar 2019. You cannot join it, but the record below documents what was studied.
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Ziauddin Hospital