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

NCT06358963 | Enrolling By Invitation DMC

• 1 other identifier: 131
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Periodontal Diseases

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• total Antioxidant capacity of saliva

  3 months

Study Arms (3)

CoQ10

EXPERIMENTAL

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; Drug: Non-Medicare Drugs

Omega-3

EXPERIMENTAL

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

No-medication;

ACTIVE COMPARATOR

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

Interventions

Receive 30 mg of Coq10 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.

Also known as: Receive 200 mg of Omega-3

CoQ10

Non-Medicare Drugs 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.

Also known as: control group

CoQ10; No-medication;; Omega-3

Eligibility Criteria

• Age: 28 Years - 35 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Amirhossein Farahmand: lead

Study Sites (1)

Amirhossein Farahmand

Tehran, 1947833113, Iran

Location

MeSH Terms

Conditions

Periodontal Diseases

Interventions

coenzyme Q10; Docosahexaenoic Acids; Control Groups

Condition Hierarchy (Ancestors)

Mouth Diseases; Stomatognathic Diseases

Intervention Hierarchy (Ancestors)

Fatty Acids, Omega-3; Dietary Fats, Unsaturated; Dietary Fats; Fats; Lipids; Fatty Acids, Unsaturated; Fatty Acids; Fish Oils; Oils; Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Research Design; Methods

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: The research was conducted using a double-blind methodology. To ensure impartiality, both the omega-3, Coq10, and control groups were given medications that had identical appearance, packaging, and color. To further eliminate bias, a clinician who had no involvement in the study labeled teh medications as A, B, and C (empty) based on their content, and distributed them among teh patients.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: periodontist,Associate Professor, Department of Periodontics, Faculty of Dentistry, Tehran Medical Sciences, Islamic Azad University, Tehran, Iran,

Model Details: Randomized, Double-blind, Controlled design.

Study Record Dates

• First Submitted: March 26, 2024
• First Posted: April 11, 2024
• Study Start: February 20, 2024
• Primary Completion: April 20, 2024
• Study Completion: May 10, 2024
• Last Updated: April 17, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: 3 months

Locations

IR (1)