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

Periodontal Diseases Clinical Trial

Official title:

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT06358963
• Other study ID #: 131
• Status: Enrolling by invitation
• Phase: N/A
• Start date: February 20, 2024
• Est. completion date: May 10, 2024

Study information

• Verified date: April 2024
• Source: Islamic Azad University, Tehran
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 80
• Est. completion date: May 10, 2024
• Est. primary completion date: April 20, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 28 Years to 35 Years

Eligibility

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

Related Conditions & MeSH terms

• Periodontal Diseases

Intervention

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.
• 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.

Locations

Country	Name	City	State
Iran, Islamic Republic of	Amirhossein Farahmand	Tehran

Sponsors (1)

Lead Sponsor	Collaborator
Amirhossein Farahmand

Country where clinical trial is conducted

Iran, Islamic Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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