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

NCT04209777 | Completed Phase 3 DMC

• 1 other identifier: MGhazal
• Study Type: interventional
• Target: 66
• Locations: 1 country
• Sites: 1

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.

Conditions

Periodontal Diseases; Smoking

Outcome Measures

Primary Outcomes (9)

• Change in Probing pocket depth

  Probing pocket depth is recorded on six sites per tooth.

  At baseline.

• Change in Probing pocket depth

  Probing pocket depth is recorded on six sites per tooth.

  After 1-month.

• Change in Probing pocket depth

  Probing pocket depth is recorded on six sites per tooth.

  After 3-months.

• Change in Clinical attachment level

  Clinical attachment level is recorded on six sites per tooth.

  At baseline.

• Change in Clinical attachment level

  Clinical attachment level is recorded on six sites per tooth.

  After 1-month.

• Change in Clinical attachment level

  Clinical attachment level is recorded on six sites per tooth.

  After 3-months.

• Change in Bleeding on probing

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

  At baseline.

• Change in Bleeding on probing

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

  After 1-month.

• Change in Bleeding on probing

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

  After 3-months.

Secondary Outcomes (6)

• Change in Plaque index

  At baseline.

• Change in Plaque index

  After 1-month.

• Change in Plaque index

  After 3-months.

• Change in Gingival index

  At baseline.

• Change in Gingival index

  After 1-month.

Study Arms (2)

Antibiotics

ACTIVE COMPARATOR

The antibiotic group is provided with amoxicillin capsules 500mg and metronidazole tablets 400mg three times a day for 7 days along with the placebo of probiotics twice daily for 30 days.

Drug: Antibiotics

Probiotics

EXPERIMENTAL

The probiotic group is provided with Lactobacillus-reuteri probiotics (2x10(8)CFU) twice daily after brushing for 30 days.

Drug: Probiotic Blend Chewable Tablet

Interventions

Probiotic Blend Chewable Tablet DRUG

Lactobacillus-reuteri probiotics were used as an experimental drug.

Also known as: Scaling and root debridement.

Probiotics

Antibiotics DRUG

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

Also known as: Scaling and root debridement.

Antibiotics

Eligibility Criteria

• Age: 35 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Dow University of Health Sciences: lead

Study Sites (1)

Mehwish Ghazal

Karachi, Sindh, Pakistan

Location

Related Publications (9)

• 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.

  PMID: 30663271 RESULT

• Morales A, Carvajal P, Silva N, Hernandez M, Godoy C, Rodriguez G, Cabello R, Garcia-Sesnich J, Hoare A, Diaz PI, Gamonal J. Clinical Effects of Lactobacillus rhamnosus in Non-Surgical Treatment of Chronic Periodontitis: A Randomized Placebo-Controlled Trial With 1-Year Follow-Up. J Periodontol. 2016 Aug;87(8):944-52. doi: 10.1902/jop.2016.150665. Epub 2016 Mar 4.

  PMID: 26944407 RESULT

• 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.

  PMID: 30931588 RESULT

• 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.

  PMID: 23176716 RESULT

• 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.

  PMID: 28678975 RESULT

• 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.

  PMID: 31620939 RESULT

• 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.

  PMID: 23253833 RESULT

• 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.

  PMID: 29364340 RESULT

• 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.

  PMID: 29604177 RESULT

MeSH Terms

Conditions

Periodontal Diseases; Smoking

Interventions

Tooth Exfoliation; Anti-Bacterial Agents

Condition Hierarchy (Ancestors)

Mouth Diseases; Stomatognathic Diseases; Behavior

Intervention Hierarchy (Ancestors)

Dental Physiological Phenomena; Digestive System and Oral Physiological Phenomena; Anti-Infective Agents; Therapeutic Uses; Pharmacologic Actions; Chemical Actions and Uses

Study Officials

• Shahbaz Ahmed, BDS/FCPS

  Dow University of Health Sciences

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Study Record Dates

• First Submitted: December 18, 2019
• First Posted: December 24, 2019
• Study Start: July 8, 2018
• Primary Completion: April 16, 2019
• Study Completion: May 6, 2019
• Last Updated: December 24, 2019

Record last verified: 2019-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: The data will be available after the publication of the study for 1 year.
• Access Criteria: Contact the principal investigator through email.

Locations

PA (1)