To Evaluate the Effects of Systemic Probiotics & Antibiotics and Local Application of Antibiotics As an Adjuvant to NSPT

Summary

Background:

Periodontitis is defined as "an inflammatory disease of the supporting tissues of the teeth caused by specific microorganisms or groups of specific microorganisms, resulting in progressive destruction of the periodontal ligament and alveolar bone with pocket formation, recession or both. It has been shown that systemic administration of antibiotics results in changes in plaque flora, reduction in gingivitis and decrease in the rate of bone resorption. In systemic administration, however, the drug must be given in high doses in order to maintain effective concentration of the drug in the gingival crevicular fluid. Whereas recent literature supports use of Local antibiotic therapy which involves the direct placement of an antimicrobial agent into sub gingival sites. The primary goal in using an intra-pocket device for the delivery of an antibacterial agent is the achievement and maintenance of therapeutic levels of the drug for the required period of time. More over use of probiotics is increasing in dentistry, Probiotics are bacterial strains usually isolated from human commensal microbiota and adequately characterized for strain identity, content, stability, and proven health effects. They come in food supplements (cheese, yoghurt, milk, lozenges) with microbial elements.

The purpose of this study is to test the clinical effects of systemic antibiotics, local delivery of 25% of metronidazole gel and probiotics after scaling and root planning in periodontitis.

Objective:

To evaluate the effects of Probiotics (Lactobacillus), antibiotics (Doxycycline 100mg) and metronidazole gel (25%) as an adjuvant to non-surgical periodontal therapy on pocket depth, clinical attachment loss and bleeding on probing after one month of intervention among patients with periodontitis.

Methods:

All study participants meeting the inclusion criteria of the study will be allocated to one of the three groups (Group 1= SRP + Antibiotics, Group 2 = SRP + probiotics and Group 3 = SRP+ LDD) through randomization. After the baseline recording of clinical periodontal parameters, non-surgical periodontal therapy will be done and Group A will be given antibiotic therapy for 14 days, group B will be given probiotics for 1 month and group C will be given LDD after NSPT. After 1-month follow-up and recording of all the clinical parameters will be done.

Conditions

• Periodontitis
• Adult

Interventions

OTHER

Antibiotics(doxycycline)

doxycycline 100 mg 2 stat the first day followed by od for 14 days

OTHER

Probiotics

Probiotic powder of Lactobacillus Reuteri. After mechanical debridement patient will be prescribed with Lactobacillus rhamnosus SP1 \[(2x107colony forming units (CFU)/ day)\] (Macrofood S.A., Santiago de Chile, Chile) for 1 month. The dose would be one sachet taken orally daily. The sachets presented to the patients would be identical. Individuals will be instructed to dissolve 1 sachet in water (150 mL) and ingest it once a day after brushing their teeth.

OTHER

Metronidazole gel 25%

After mechanical debridement, 25% of metronidazole gel was administered into the periodontal pockets. The gel was applied with a parojet syringe provided with a blunt cannula

Sponsors & Collaborators

• Dr fizza khalid

  lead OTHER

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Model

PARALLEL

Eligibility

Min Age

25 Years

Max Age

65 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2022-07-01

Primary Completion

2024-02-02

Completion

2024-12-03

Countries

• Pakistan

Study Locations