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Completed

NCT Number: NCT04209777

Clinical Evaluation of Smoker Periodontal Subjects After Lactobacillus-reuteri Probiotics and Antibiotics Therapy

It is a clinical trial conducted on smokers with chronic periodontitis in which the participants are divided into two groups and one group is provided with antibiotics while the other with probiotics as an adjunct to non-surgical therapy. The participants were assessed for change in probing pocket depths, attachment loss, bleeding on probing, plaque index and gingival index after 1-month and 3-month period.

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Key information

Conditions

Periodontal Diseases Behavior Mouth Diseases Smoking Stomatognathic Diseases

Age range

35 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Mehwish Ghazal

Karachi, Sindh, Pakistan

About this study

Background:

Periodontal disease is a chronic inflammatory disease of the supporting structures of the tooth which includes periodontal ligament, cementum, and bone. Conventional periodontal therapy involves a non-surgical and surgical method for mechanical debridement of supragingival and subgingival sites to eliminate the pathogens and reduce inflammation of the periodontium. Smokers respond less to conventional therapy and require antibiotics for additional benefits. Where the use of antibiotics provides benefits to the host, the increasing proportion of developing antibiotic resistance are a major concern. The introduction of "Probiotics" as a treatment option is under special consideration. According to WHO, Probiotics are defined as viable micro-organisms which when delivered in an appropriate dose, provides health benefits. Lactobacillus-reuteri has been considered as a reliable option in regards to safety with no reported adverse effects, in the treatment of periodontitis as an adjunct to Scaling and Root Debridement.

Objectives:

The objective of the present study is to evaluate the clinical improvement of Lactobacillusreuteri Probiotics in comparison to a combination of amoxicillin and metronidazole antibiotics in smokers with moderate to severe chronic periodontitis after non-surgical scaling and root debridement.

Method:

A total number of 60 Smokers with moderate to severe chronic periodontitis were randomized into two groups after taking consent. Group 1 received amoxicillin and metronidazole for 7 days and placebo for Probiotics for 30 days. Group 2 was provided with 1 tablet of Lactobacillus-reuteri Probiotics (2x108CFU) twice daily after brushing for 30 days and a placebo for antibiotics for 7 days. At recruitment, scaling and root debridement were performed and change in pocket depth, attachment loss, gingival index, plaque index and bleeding on probing were recorded. The same outcomes were recorded again at 1 month and 3 months follow-up. Mean, standard deviation and confidence interval were reported using SPSS version-20.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • systemically healthy males or females.
  • at least 35 years of age with minimal 3 natural teeth in each quadrant excluding 3rd molar.
  • previously untreated moderate to severe generalized chronic periodontitis
  • were current smokers having ≥10 cigarettes /day.

Exclusion criteria

  • having periodontal therapy within the past 6 months.
  • have undergone antibiotics or long-term NSAIDS therapy within the past 6 months.
  • have an allergy to penicillin and metronidazole.
  • having either fixed or removable prosthesis.
  • pregnant or nursing females.

Treatment and study plan

Probiotic Blend Chewable Tablet

Drug

Lactobacillus-reuteri probiotics were used as an experimental drug.

Other names: Scaling and root debridement.

Antibiotics

Drug

Amoxicillin capsules 500mg and metronidazole tablets 400mg antibiotics were used as an active comparator.

Other names: Scaling and root debridement.

Primary outcomes

  1. Change in Probing pocket depth

    Time frame: At baseline.

    Probing pocket depth is recorded on six sites per tooth.

  2. Change in Probing pocket depth

    Time frame: After 1-month.

    Probing pocket depth is recorded on six sites per tooth.

  3. Change in Probing pocket depth

    Time frame: After 3-months.

    Probing pocket depth is recorded on six sites per tooth.

  4. Change in Clinical attachment level

    Time frame: At baseline.

    Clinical attachment level is recorded on six sites per tooth.

  5. Change in Clinical attachment level

    Time frame: After 1-month.

    Clinical attachment level is recorded on six sites per tooth.

  6. Change in Clinical attachment level

    Time frame: After 3-months.

    Clinical attachment level is recorded on six sites per tooth.

  7. Change in Bleeding on probing

    Time frame: At baseline.

    Bleeding on probing is recorded on six sites per tooth. Presence or absence of bleeding is checked.

  8. Change in Bleeding on probing

    Time frame: After 1-month.

    Bleeding on probing is recorded on six sites per tooth. Presence or absence of bleeding is checked.

  9. Change in Bleeding on probing

    Time frame: After 3-months.

    Bleeding on probing is recorded on six sites per tooth. Presence or absence of bleeding is checked.

Secondary outcomes

  1. Change in Plaque index

    Time frame: At baseline.

    Plaque index is recorded to check deposits on six teeth which are left upper first molar, upper left lateral incisor, upper right premolar, and lower right first molar, lower right lateral incisor and lower left premolar. all the six sites of each tooth are examined.

    0= No plaque; 1= A film of plaque adhering to the free gingival margin and adjacent area of the tooth; 2= Moderate accumulation of soft deposits within the gingival pocket, or the tooth and gingival margin which can be seen with the naked eye; 3= Abundance of soft matter within the gingival pocket and/or on the tooth and gingival margin.

  2. Change in Plaque index

    Time frame: After 1-month.

    Plaque index is recorded to check deposits on six teeth which are left upper first molar, upper left lateral incisor, upper right premolar, and lower right first molar, lower right lateral incisor and lower left premolar. all the six sites of each tooth are examined.

    0= No plaque; 1= A film of plaque adhering to the free gingival margin and adjacent area of the tooth; 2= Moderate accumulation of soft deposits within the gingival pocket, or the tooth and gingival margin which can be seen with the naked eye; 3= Abundance of soft matter within the gingival pocket and/or on the tooth and gingival margin.

  3. Change in Plaque index

    Time frame: After 3-months.

    Plaque index is recorded to check deposits on six teeth which are left upper first molar, upper left lateral incisor, upper right premolar, and lower right first molar, lower right lateral incisor and lower left premolar. all the six sites of each tooth are examined.

    0= No plaque; 1= A film of plaque adhering to the free gingival margin and adjacent area of the tooth; 2= Moderate accumulation of soft deposits within the gingival pocket, or the tooth and gingival margin which can be seen with the naked eye; 3= Abundance of soft matter within the gingival pocket and/or on the tooth and gingival margin.

  4. Change in Gingival index

    Time frame: At baseline.

    Gingival index is recorded on six teeth which are left upper first molar, upper left lateral incisor, upper right premolar, and lower right first molar, lower right lateral incisor and lower left premolar. mesio-buccal, disto-buccal, buccal/facial margin and lingual gingival margin is assessed.

    0= Normal gingiva; 1= Mild inflammation - slight change in color and slight edema but no bleeding on probing; 2= Moderate inflammation - redness, edema and glazing, bleeding on probing; 3= Severe inflammation - marked redness and edema, ulceration with tendency to spontaneous bleeding.

  5. Change in Gingival index

    Time frame: After 1-month.

    Gingival index is recorded on six teeth which are left upper first molar, upper left lateral incisor, upper right premolar, and lower right first molar, lower right lateral incisor and lower left premolar. mesio-buccal, disto-buccal, buccal/facial margin and lingual gingival margin is assessed.

    0= Normal gingiva; 1= Mild inflammation - slight change in color and slight edema but no bleeding on probing; 2= Moderate inflammation - redness, edema and glazing, bleeding on probing; 3= Severe inflammation - marked redness and edema, ulceration with tendency to spontaneous bleeding.

  6. Change in Gingival index

    Time frame: After 3-months.

    Gingival index is recorded on six teeth which are left upper first molar, upper left lateral incisor, upper right premolar, and lower right first molar, lower right lateral incisor and lower left premolar. mesio-buccal, disto-buccal, buccal/facial margin and lingual gingival margin is assessed.

    0= Normal gingiva; 1= Mild inflammation - slight change in color and slight edema but no bleeding on probing; 2= Moderate inflammation - redness, edema and glazing, bleeding on probing; 3= Severe inflammation - marked redness and edema, ulceration with tendency to spontaneous bleeding.

Sponsors and collaborators

Lead sponsor

Dow University of Health Sciences

Other

Registry information

Official study title

Clinical Evaluation of Smoker Periodontal Subjects After Lactobacillus-reuteri Probiotics and Antibiotics Therapy With Scaling and Root Debridement: a Clinical Trial

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Dec 24, 2019
Registry last updated
Dec 24, 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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