Clinical trial NCT04209777: Clinical Evaluation of Smoker Periodontal Subjects After Lactobacillus-reuteri Probiotics and Antibiotics Therapy
Official title: Clinical Evaluation of Smoker Periodontal Subjects After Lactobacillus-reuteri Probiotics and Antibiotics Therapy With Scaling and Root Debridement: a Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Periodontal Diseases
Smoking
Lead sponsor: Dow University of Health Sciences
Sponsor class: OTHER
First posted: 2019-12-24
Enrollment: 66
Sex: ALL
Minimum age (years): 35
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Change in Probing pocket depth
timeFrame: At baseline.
measure: Change in Probing pocket depth
timeFrame: After 1-month.
measure: Change in Probing pocket depth
timeFrame: After 3-months.
measure: Change in Clinical attachment level
timeFrame: At baseline.
measure: Change in Clinical attachment level
timeFrame: After 1-month.
measure: Change in Clinical attachment level
timeFrame: After 3-months.
measure: Change in Bleeding on probing
timeFrame: At baseline.
measure: Change in Bleeding on probing
timeFrame: After 1-month.
measure: Change in Bleeding on probing
timeFrame: After 3-months.
Secondary outcomes:
measure: Change in Plaque index
timeFrame: At baseline.
measure: Change in Plaque index
timeFrame: After 1-month.
measure: Change in Plaque index
timeFrame: After 3-months.
measure: Change in Gingival index
timeFrame: At baseline.
measure: Change in Gingival index
timeFrame: After 1-month.
measure: Change in Gingival index
timeFrame: After 3-months.
Other outcomes:
Locations:
city: Karachi
country: Pakistan
facility: Mehwish Ghazal
state: Sindh
Study officials:
affiliation: Dow University of Health Sciences
name: Shahbaz Ahmed, BDS/FCPS
role: STUDY_DIRECTOR
References:
citation: Ikram S, Hassan N, Baig S, Borges KJJ, Raffat MA, Akram Z. Effect of local probiotic (Lactobacillus reuteri) vs systemic antibiotic therapy as an adjunct to non-surgical periodontal treatment in chronic periodontitis. J Investig Clin Dent. 2019 May;10(2):e12393. doi: 10.1111/jicd.12393. Epub 2019 Jan 20.
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citation: Theodoro LH, Claudio MM, Nuernberg MAA, Miessi DMJ, Batista JA, Duque C, Garcia VG. Effects of Lactobacillus reuteri as an adjunct to the treatment of periodontitis in smokers: randomised clinical trial. Benef Microbes. 2019 Apr 19;10(4):375-384. doi: 10.3920/BM2018.0150. Epub 2019 Apr 1.
citation: Vicario M, Santos A, Violant D, Nart J, Giner L. Clinical changes in periodontal subjects with the probiotic Lactobacillus reuteri Prodentis: a preliminary randomized clinical trial. Acta Odontol Scand. 2013 May-Jul;71(3-4):813-9. doi: 10.3109/00016357.2012.734404. Epub 2012 Nov 26.
citation: Assem NZ, Alves MLF, Lopes AB, Gualberto EC Junior, Garcia VG, Theodoro LH. Antibiotic therapy as an adjunct to scaling and root planing in smokers: a systematic review and meta-analysis. Braz Oral Res. 2017 Jul 3;31:e67. doi: 10.1590/1807-3107BOR-2017.vol31.0067.
citation: Grusovin MG, Bossini S, Calza S, Cappa V, Garzetti G, Scotti E, Gherlone EF, Mensi M. Clinical efficacy of Lactobacillus reuteri-containing lozenges in the supportive therapy of generalized periodontitis stage III and IV, grade C: 1-year results of a double-blind randomized placebo-controlled pilot study. Clin Oral Investig. 2020 Jun;24(6):2015-2024. doi: 10.1007/s00784-019-03065-x. Epub 2019 Oct 16.
citation: Albandar JM. Adjunctive antibiotics with nonsurgical periodontal therapy improve the clinical outcome of chronic periodontitis in current smokers. J Evid Based Dent Pract. 2012 Sep;12(3 Suppl):63-6. doi: 10.1016/S1532-3382(12)70015-5.
citation: Morales A, Gandolfo A, Bravo J, Carvajal P, Silva N, Godoy C, Garcia-Sesnich J, Hoare A, Diaz P, Gamonal J. Microbiological and clinical effects of probiotics and antibiotics on nonsurgical treatment of chronic periodontitis: a randomized placebo- controlled trial with 9-month follow-up. J Appl Oral Sci. 2018 Jan 18;26:e20170075. doi: 10.1590/1678-7757-2017-0075.
citation: Ikram S, Hassan N, Raffat MA, Mirza S, Akram Z. Systematic review and meta-analysis of double-blind, placebo-controlled, randomized clinical trials using probiotics in chronic periodontitis. J Investig Clin Dent. 2018 Aug;9(3):e12338. doi: 10.1111/jicd.12338. Epub 2018 Mar 31.