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Completed

NCT Number: NCT04697199

The Adjunctive Effect of Probiotics to Non Surgical Treatment of Chronic Periodontitis

Evaluation of clinical and microbiological effect of lactobacillus reuteri probiotics.

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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 Stomatognathic Diseases

Age range

35 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Ghadeer

Tanta, Egypt

About this study

The present randomized controlled clinical trial was conducted to evaluate the effects of Lactobacillus reuteri-containing probiotic suspension as an adjunct to scaling and root planing (SRP).

Material and Methods: Twenty sites from twelve chronic periodontitis patients were recruited and monitored clinically and microbiologically at baseline, three, and six months after therapy for plaque index (PI), bleeding on probing (BOP), probing pocket depth (PPD) and clinical attachment level (CAL) and microbiologically or Porphyromonas gingivalis (P. gingivalis) load. Patients meeting the inclusion criteria were scheduled within one week for two sessions of SRP performed using ultrasonic scalers and hand instrumentation. After SRP, oral hygiene measures were reassured and then sites were randomly allocated to one of the two groups 10 sites each. group I (SRP only) and group II (SRP + probiotic). Group II received SRP and sub-gingival delivery of 1ml of probiotic L. reuteri suspension at baseline (immediately after SRP), one, two and four weeks using blunt syringe. Periodontal dressing was applied after placement of the drug.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Patients with good systemic health.
  • Patients with moderate chronic periodontitis with attachment level ranging from 3-4 mm.
  • Optimal compliance as evidenced by no missed treatment appointments and positive attitude towards oral hygiene.
  • No gingival recession.

Exclusion criteria

  • Patients with history of antibiotic, anti-inflammatory drugs or periodontal therapy in the preceding 6 months.
  • Patients with risk factors (e.g. - smoking, uncontrolled diabetes, uncontrolled hypertension, pregnant or any other systemic disease which can alter the course of periodontal therapy).
  • Patients who are allergic to lactate products.

Treatment and study plan

Lactobacillus reuteri Oral Drops

Drug

Subgingival delivery of probiotic suspension

Other names: Scaling and root planing

Scaling and Root Planing

Procedure

Scaling and root planing using hand and ultrasonic instruments

Primary outcomes

  1. Change in Probing pocket depth

    Time frame: Baseline. 3 months. 6 months

    Individual acrylic stents were prepared to serve as the constant points to align the probe consistently and to reduce errors associated with probe placement. Probing pocket depth was assessed using a manual probe (UNC-15). The distance from the free gingival margin to the bottom of the pocket was recorded at six sites for each examined tooth. The probe was inserted in line with the long axis of the tooth and walked circumferentially around each surface of each tooth to detect and record the area of the deepest probe penetration. The mean probing pocket depth was obtained by summing the scores for the six sites and dividing it by six.

Secondary outcomes

  1. Change in Plaque index

    Time frame: Baseline, 3 and 6 months

    This index distinguishes clearly between the severity and the location of soft debris aggregates.

  2. Change in Bleeding on probing

    Time frame: Baseline, 3 and 6 months

    Bleeding on probing was performed through gentle probing of the orifice of the gingival crevice. If bleeding occurs within 10 seconds, the number of positive sites is recorded and then expressed as a percentage of the number of sites examined.

  3. Change in Clinical attachment level

    Time frame: Baseline, 3 and 6 months

    The distance from cementoenamel junction to the bottom of the pocket was measured in the same way as described for probing

Sponsors and collaborators

Lead sponsor

Tanta University

Other

Registry information

Important dates

Study start
2018
Primary completion
2019
Study completion
2020
First posted
Jan 6, 2021
Registry last updated
Jan 6, 2021

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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