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Completed

NCT Number: NCT03499184

Adjunctive Probiotics in Chronic Periodontitis

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.

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Key information

Conditions

Chronic Periodontitis Chronic Disease Disease Attributes Mouth Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Periodontal Diseases Periodontitis Probiotics Stomatognathic Diseases

Age range

30 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Ziauddin Dental College

Karachi, Sindh, 75600, Pakistan

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients with clinically diagnosed chronic periodontitis with a pocket depth of ≥4mm.
  • Patients with age ≥30 years.

Exclusion criteria

  • Handicapped patients who are physically or mentally unable to maintain their oral hygiene.
  • Pregnant and lactating females.
  • Patients with habits of smoking, chewing tobacco and alcohol consumption.
  • Patients on local or systemic antibiotic treatment.
  • Patients with any systemic diseases.
  • Patients with the history of any periodontal therapy within last 6 months.
  • Patients undergoing orthodontic treatment.

Treatment and study plan

P Flor locally delivered

Dietary Supplement

Locally delivered Lactobacillus reuteri 1.2 CFU per gram

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

Primary outcomes

  1. Change in periodontal pocket depth (PPD)

    Time frame: Baseline, 3, 6, 9 and 12 weeks

    It is the distance from tip of free gingival margin to the base of pocket

  2. Change in clinical attachment level (CAL)

    Time frame: Baseline, 3, 6, 9 and 12 weeks

    It is the distance from cementoenamel junction to the base of the pocket around the tooth

  3. Change in bacterial load of Porphyromonas gingivalis

    Time frame: Baseline and 12 weeks after completion of trial

    Bacterial count or the quantity of porphyromonas gingivalis in the sample

Secondary outcomes

  1. Change in the Plaque index (PI)

    Time frame: Baseline, 3, 6, 9 and 12 weeks

    How much surface of tooth is covered by the plaque will be recorded.

  2. Change in Gingival index (GI)

    Time frame: Baseline, 3, 6, 9 and 12 weeks

    Gingival color texture and inflammation will be recorded.

Sponsors and collaborators

Lead sponsor

Ziauddin Hospital

Other

Registry information

Official study title

Effect of Probiotic Along With Scaling and Root Planing in the Treatment of Chronic Periodontitis

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Apr 17, 2018
Registry last updated
Mar 12, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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