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

NCT ID: NCT06358963

Last Updated: 2024-04-17

Basic Information

• Recruitment Status: ENROLLING_BY_INVITATION
• Clinical Phase: NA
• Total Enrollment: 80 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-02-20
• Study Completion Date: 2024-05-10

Brief Summary

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

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.

Conditions

Periodontal Diseases

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

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.

Group Type: EXPERIMENTAL

Receive 30 mg of Coq10

Intervention Type: DRUG

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.

Non-Medicare Drugs

Intervention Type: DRUG

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.

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.

Group Type: EXPERIMENTAL

Non-Medicare Drugs

Intervention Type: DRUG

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.

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.

Group Type: ACTIVE_COMPARATOR

Non-Medicare Drugs

Intervention Type: DRUG

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.

Interventions

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.

Intervention Type: 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.

Intervention Type: DRUG

Other Intervention Names

Receive 200 mg of Omega-3; control group

Eligibility Criteria

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

• Minimum Eligible Age: 28 Years
• Maximum Eligible Age: 35 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Amirhossein Farahmand

OTHER

Sponsor Role: lead

Responsible Party

Amirhossein Farahmand

periodontist,Associate Professor, Department of Periodontics, Faculty of Dentistry, Tehran Medical Sciences, Islamic Azad University, Tehran, Iran,

Responsibility Role: SPONSOR_INVESTIGATOR

Locations

Amirhossein Farahmand

Tehran, , Iran

Countries

Iran

Other Identifiers

131

Identifier Type: -

Identifier Source: org_study_id