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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04209777
Recruitment Status : Completed
First Posted : December 24, 2019
Last Update Posted : December 24, 2019
Sponsor:
Information provided by (Responsible Party):
Mehwish Ghazal, Dow University of Health Sciences

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.

Condition or disease Intervention/treatment Phase
Periodontal Diseases Smoking Drug: Probiotic Blend Chewable Tablet Drug: Antibiotics Phase 3

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 66 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Clinical Evaluation of Smoker Periodontal Subjects After Lactobacillus-reuteri Probiotics and Antibiotics Therapy With Scaling and Root Debridement: a Clinical Trial
Actual Study Start Date : July 8, 2018
Actual Primary Completion Date : April 16, 2019
Actual Study Completion Date : May 6, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Antibiotics

Arm Intervention/treatment
Active Comparator: Antibiotics
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
Amoxicillin capsules 500mg and metronidazole tablets 400mg antibiotics were used as an active comparator.
Other Name: Scaling and root debridement.

Experimental: Probiotics
The probiotic group is provided with Lactobacillus-reuteri probiotics (2x10(8)CFU) twice daily after brushing for 30 days.
Drug: Probiotic Blend Chewable Tablet
Lactobacillus-reuteri probiotics were used as an experimental drug.
Other Name: Scaling and root debridement.




Primary Outcome Measures :
  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 Outcome Measures :
  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.




Information from the National Library of Medicine

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Ages Eligible for Study:   35 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04209777


Locations
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Pakistan
Mehwish Ghazal
Karachi, Sindh, Pakistan
Sponsors and Collaborators
Dow University of Health Sciences
Investigators
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Study Director: Shahbaz Ahmed, BDS/FCPS Dow University of Health Sciences
Publications of Results:

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Responsible Party: Mehwish Ghazal, Principal investigator, Dow University of Health Sciences
ClinicalTrials.gov Identifier: NCT04209777    
Other Study ID Numbers: MGhazal
First Posted: December 24, 2019    Key Record Dates
Last Update Posted: December 24, 2019
Last Verified: December 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: The data will be available for sharing after 6-months of publication.
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (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.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Additional relevant MeSH terms:
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Periodontal Diseases
Mouth Diseases
Stomatognathic Diseases
Anti-Bacterial Agents
Anti-Infective Agents