CoQ10 and Omega-3 as Adjuncts to Periodontal Therapy, TAC of Saliva.

Comparative Evaluation of CoQ10 and Omega-3 as Adjuncts to Periodontal Therapy and Total Antioxidant Capacity of Saliva.

Comparative evaluation of CoQ10 and Omega-3 as adjuncts to periodontal therapy and total antioxidant capacity of saliva (randomized Double-Blind Clinicalials)

Study Overview

• Status: Enrolling by invitation
• Conditions: Periodontal Diseases
• Intervention / Treatment: Drug: Receive 30 mg of Coq10; Drug: Non-Medicare Drugs

Detailed Description

This study was designed as a blind, randomized clinical trial to evaluate teh efficacy of Coq10, Omega-3 supplement on periodontal parameters in chronic periodontitis patients, total antioxidant capacity in saliva after 2 months of administration;75 patients to department of periodontics were selected from teh patients referred to Broujerd dental school of teh Islamic Azad University of Medical Sciences; before commencing teh study, several clinical periodontal parameters were evaluated, including plaque index, bleeding on probing, gingival index, probing depth, and clinical attachment level(CAL) in six different areas of teh tooth surface; subsequently, scaling and root planning(SRP) were performed, and oral hygiene practices were improved for all participants. Teh subjects were then randomly assigned to three groups: Group A received 30 mg of CoQ10, Group B was given 200 mg of Omega-3 daily supplements, and Group C did not receive any medication; after teh two-month study period, teh clinical periodontal parameters were reassessed. Additionally, to compare teh total antioxidant capacity in saliva before and after teh intake of these supplements, as well as in patients who did not receive any medication, 2 ml of non-stimulated saliva was collected from each participant at teh beginning and end of teh study for analysis using UV-spectrophotometric methods, furthermore, teh following criteria determined teh selection of eligible participants for this study.

• Study Type: Interventional
• Enrollment (Estimated): 80
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Iran, Islamic Republic of
  • Tehran, Iran, Islamic Republic of, 1947833113
    • Amirhossein Farahmand

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

Aged between 28 and 35, chronic initial periodontal disease (newly classified as Stage-I), with a maximum pocket depth of 5 mm, and mandibular molar teeth. in each quadrant

Exclusion Criteria:

Systemic disease Orthodontic treatments in progress Pregnancy and breastfeeding Taking medicines affecting periodontium such as antibiotics for the last 6 months Malignancy, radiotherapy, and chemotherapy for malignancy in the last 5 years Plaque index and bleeding scores below 25% History of periodontal surgery at the desired site for the last 6 months Taking medicinal supplements within the last 6 months Cigarette smoking or tobacco use

Study population 80eligibles were enrolled in this study, which was designed for Randomized Double-Blind Clinical Trials

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Omega-3; Group B will be given 200 mg of Omega-3 daily supplements, and Group C did not receive any medication; after the two-month study period, the clinical periodontal parameters were reassessed. Additionally, to compare the total antioxidant capacity in saliva before and after the intake of these supplements, as well as in patients who did not receive any medication, 2 ml of non-stimulated saliva was collected from each participant at the beginning and end of the study for analysis using UV-spectrophotometric methods, furthermore, the following criteria determined the selection of eligible participants for dis study.	Drug: Non-Medicare Drugs; and Group C did not receive any medication; after the two-month study period, the clinical periodontal parameters were reassessed. Additionally, to compare teh total antioxidant capacity in saliva before and after teh intake of these supplements, as well as in patients who did not receive any medication, 2 ml of non-stimulated saliva was collected from each participant at teh beginning and end of teh study for analysis using UV-spectrophotometric methods, furthermore, teh following criteria determined teh selection of eligible participants for dis study.; Other Names: control group
Experimental: CoQ10; Group A will receive 30 mg of CoQ10 daily, after teh two-month study period, teh clinical periodontal parameters were reassessed. Additionally, to compare teh total antioxidant capacity in saliva before and after teh intake of these supplements, as well as in patients who did not receive any medication, 2 ml of non-stimulated saliva was collected from each participant at teh beginning and end of teh study for analysis using UV-spectrophotometric methods, furthermore, teh following criteria determined teh selection of eligible participants for dis study.	Drug: Receive 30 mg of Coq10; Group A received 30 mg of CoQ10, Group B was given 200 mg of Omega-3 daily supplements, and Group C did not receive any medication; after the two-month study period, teh clinical periodontal parameters were reassessed. Additionally, to compare teh total antioxidant capacity in saliva before and after teh intake of these supplements, as well as in patients who did not receive any medication, 2 ml of non-stimulated saliva was collected from each participant at teh beginning and end of teh study for analysis using UV-spectrophotometric methods, furthermore, teh following criteria determined teh selection of eligible participants for dis study.; Other Names: Receive 200 mg of Omega-3; Drug: Non-Medicare Drugs; and Group C did not receive any medication; after the two-month study period, the clinical periodontal parameters were reassessed. Additionally, to compare teh total antioxidant capacity in saliva before and after teh intake of these supplements, as well as in patients who did not receive any medication, 2 ml of non-stimulated saliva was collected from each participant at teh beginning and end of teh study for analysis using UV-spectrophotometric methods, furthermore, teh following criteria determined teh selection of eligible participants for dis study.; Other Names: control group
Active Comparator: No-medication; Group C did not receive any medication; after the two-month study period, the clinical periodontal parameters were reassessed. Additionally, to compare the total antioxidant capacity in saliva before and after the intake of these supplements, as well as in patients who did not receive any medication, 2 ml of non-stimulated saliva was collected from each participant at the beginning and end of the study for analysis using UV-spectrophotometric methods, furthermore, the following criteria determined the selection of eligible participants for this study.	Drug: Non-Medicare Drugs; and Group C did not receive any medication; after the two-month study period, the clinical periodontal parameters were reassessed. Additionally, to compare teh total antioxidant capacity in saliva before and after teh intake of these supplements, as well as in patients who did not receive any medication, 2 ml of non-stimulated saliva was collected from each participant at teh beginning and end of teh study for analysis using UV-spectrophotometric methods, furthermore, teh following criteria determined teh selection of eligible participants for dis study.; Other Names: control group

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
reduction of bleeding on probing	The bleeding index will be assessed using a periodontal probe and compared wif other groups on both the initial and final days of the research.	3 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
total Antioxidant capacity of saliva	UV-Spectrophotometry , to compare teh total antioxidant capacity in saliva before and after teh intake of these supplements, as well as in patients who did not receive any medication, 2 ml of non-stimulated saliva was collected from each participant at teh beginning and end of teh study for analysis using UV-spectrophotometric methods, furthermore, teh following criteria determined teh selection of eligible participants for dis study.	3 months

Collaborators and Investigators

• Sponsor: Amirhossein Farahmand

Study record dates

Study Major Dates

• Study Start (Actual): February 20, 2024
• Primary Completion (Estimated): April 20, 2024
• Study Completion (Estimated): May 10, 2024

Study Registration Dates

• First Submitted: March 26, 2024
• First Submitted That Met QC Criteria: April 5, 2024
• First Posted (Actual): April 11, 2024

Study Record Updates

• Last Update Posted (Actual): April 17, 2024
• Last Update Submitted That Met QC Criteria: April 16, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Stomatognathic Diseases; Mouth Diseases; Periodontal Diseases; Physiological Effects of Drugs; Micronutrients; Vitamins; Coenzyme Q10
• Other Study ID Numbers: 131 (Tumor Vaccine Group)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: The availability of individual participant data sets for sharing is a source of great satisfaction for me. These IPS, which form the basis of published results, can be readily shared with others.
• IPD Sharing Time Frame: 3 months
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No