Microbial Profiling in Pockets Related to Chronic Periodontitis Patients Using 16s RNA Metagenomics Sequencing

NCT04425343 | Completed DMC

• 1 other identifier: F-H-17-11-03
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

The study was developed in compliance with the Helsinki Declaration on medical research involving the Ethics Committee at Ajman University (2017-A-DN-04). Informed consent from all the participants was obtained before participation in the study. The participants were systemically healthy with no history of antibiotics for the past three months. Patients recruited for the study were diagnosed as Stage II Generalized periodontitis according to the classification from the 2017 world workshop on the "classification of periodontal and peri-implant disease and conditions". Periodontal status indicating the severity of interdental clinical attachment loss of 3-4mm, radiographic bone loss between 15%-33% and with no tooth loss were included. The complexity of periodontitis with a maximum probing depth of ≤ 5mm with horizontal bone loss and having an extent and distribution with \>30% teeth involved were included in the study. A total of 80 plaque samples were collected with the clinical characteristics of the patient comprising of age between 25-39 years, 36 females and 44 males. The subgingival plaque was collected using a sterile curette from the buccal aspect of maxillary molars and lingual aspect of mandibular incisors, in a vial containing 200µl of Buffer CL.

Conditions

Periodontal Diseases

Keywords

metagenomics; 16S; Periodontitis, Adult

Outcome Measures

Primary Outcomes (1)

• Microbial Taxonomical Composition

  The composition was determined using subgingival plaque samples and performing 16s metagenomic sequencing

  From Baseline to 3 months

Study Arms (2)

Periodontitis, Adult

EXPERIMENTAL

Plaque samples were taken from subgingival pocket and send to the lab for metagenomic analysis

Genetic: 16s RNA Metagenomics sequencing

Metgenomic analysis

EXPERIMENTAL

Analysis for whole bacterial count

Genetic: 16s RNA Metagenomics sequencing

Interventions

16s RNA Metagenomics sequencing GENETIC

The subgingival plaque was collected using a sterile curette from the buccal aspect of maxillary molars and lingual aspect of mandibular incisors, in a vial containing 200µl of Buffer CL.

Also known as: DNA isolation

Metgenomic analysis; Periodontitis, Adult

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Patients recruited for the study were diagnosed as Stage II Generalized periodontitis
• Medically fit

You may not qualify if:

• Patients having gingivitis or stage III periodontitis
• Medically unfit

Sponsors & Collaborators

• Ajman University: lead

Study Sites (1)

Ajman University of Science and Technology

Ajman, 009716, United Arab Emirates

Location

MeSH Terms

Conditions

Periodontal Diseases; Chronic Periodontitis

Condition Hierarchy (Ancestors)

Mouth Diseases; Stomatognathic Diseases; Periodontitis; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Sudhir Varma, MDS

  Assistant Professor

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Masking Details: . A total of 80 plaque samples were collected with the clinical characteristics of the patient comprising of age between 25-39 years, 36 females and 44 males
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Model Details: . Patients recruited for the study were diagnosed as Stage II Generalized periodontitis according to the classification from the 2017 world workshop on the "classification of periodontal and peri-implant disease and conditions". Periodontal status indicating the severity of interdental clinical attachment loss of 3-4mm, radiographic bone loss between 15%-33% and with no tooth loss were included. The complexity of periodontitis with a maximum probing depth of ≤ 5mm with horizontal bone loss and having an extent and distribution with \>30% teeth involved were included in the study.

Study Record Dates

• First Submitted: June 7, 2020
• First Posted: June 11, 2020
• Study Start: November 10, 2017
• Primary Completion: September 15, 2018
• Study Completion: October 7, 2019
• Last Updated: June 11, 2020

Record last verified: 2020-06

Data Sharing

• IPD Sharing: Will not share

Locations

AE (1)