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

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

Status
Completed
Phases
Phase 1
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04697199
Enrollment
12
Registered
2021-01-06
Start date
2018-09-01
Completion date
2020-02-06
Last updated
2021-01-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic Periodontitis

Keywords

Chronic periodontitis

Brief summary

Evaluation of clinical and microbiological effect of lactobacillus reuteri probiotics.

Detailed description

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.

Interventions

Subgingival delivery of probiotic suspension

PROCEDUREScaling and root planing

Scaling and root planing using hand and ultrasonic instruments

Sponsors

Tanta University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
35 Years to 55 Years
Healthy volunteers
No

Inclusion criteria

1. Patients with good systemic health. 2. Patients with moderate chronic periodontitis with attachment level ranging from 3-4 mm. 3. Optimal compliance as evidenced by no missed treatment appointments and positive attitude towards oral hygiene. 4. No gingival recession.

Exclusion criteria

1. Patients with history of antibiotic, anti-inflammatory drugs or periodontal therapy in the preceding 6 months. 2. 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). 3. Patients who are allergic to lactate products.

Design outcomes

Primary

MeasureTime frameDescription
Change in Probing pocket depthBaseline. 3 months. 6 monthsIndividual 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

MeasureTime frameDescription
Change in Plaque indexBaseline, 3 and 6 monthsThis index distinguishes clearly between the severity and the location of soft debris aggregates.
Change in Bleeding on probingBaseline, 3 and 6 monthsBleeding 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.
Change in Clinical attachment levelBaseline, 3 and 6 monthsThe distance from cementoenamel junction to the bottom of the pocket was measured in the same way as described for probing

Countries

Egypt

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026