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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Local Probiotics | Experimental | P Flor (Lactobacillus reuteri 1.2 billion CFU) will be delivered locally every 12 hours for 12 weeks |
|
| Systemic Probiotics | Experimental | P Flor (Lactobacillus reuteri 1.2 billion CFU) will be administered every 12 hours for 12 weeks |
|
| Systemic Antibiotics | Active Comparator | Amoxil 500 mg capsule and Flagyl 400 mg tablet by mouth, will be given every 8 hours for 5 days |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| P Flor locally delivered | Dietary Supplement | Locally delivered Lactobacillus reuteri 1.2 CFU per gram |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in periodontal pocket depth (PPD) | It is the distance from tip of free gingival margin to the base of pocket | 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 | 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 | Baseline and 12 weeks after completion of trial |
| Measure | Description | Time Frame |
|---|---|---|
| Change in the Plaque index (PI) | How much surface of tooth is covered by the plaque will be recorded. | Baseline, 3, 6, 9 and 12 weeks |
| Change in Gingival index (GI) | Gingival color texture and inflammation will be recorded. |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ziauddin Dental College | Karachi | Sindh | 75600 | Pakistan |
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| ID | Term |
|---|---|
| D055113 | Chronic Periodontitis |
| ID | Term |
|---|---|
| D010518 | Periodontitis |
| D010510 | Periodontal Diseases |
| D009059 | Mouth Diseases |
| D009057 | Stomatognathic Diseases |
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| ID | Term |
|---|---|
| D000658 | Amoxicillin |
| D008795 | Metronidazole |
| D013607 | Tablets |
| ID | Term |
|---|---|
| D000667 | Ampicillin |
| D010400 | Penicillin G |
| D010406 | Penicillins |
| D047090 | beta-Lactams |
| D007769 |
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| P Flor systemically administered | Dietary Supplement | Systemically administered Lactobacillus reuteri 1.2 CFU per gram |
|
| Amoxil 500 mg Oral Capsule | Drug | Systemically administered Amoxil 500 mg thrice daily |
|
| Flagyl 400 mg Tablet | Drug | Systemically administered Metronidazole 400 mg twice daily |
|
| Baseline, 3, 6, 9 and 12 weeks |
| D002908 |
| Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| Lactams |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D013457 | Sulfur Compounds |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| D009593 | Nitroimidazoles |
| D009574 | Nitro Compounds |
| D007093 | Imidazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D004304 | Dosage Forms |
| D004364 | Pharmaceutical Preparations |