Impact of Non-surgical Periodontal Therapy in the Improvement of Early Endothelial Dysfunction in Subjects With Periodontitis.

• Sponsor: University of Catania (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT05906797
• Collaborator: (none)
• Enrollment: 60
• Location: 1
• Arms: 2
• Anticipated Duration (Months): 38.7
• Patients Per Site Per Month: 1.5

Study Details

Study Description

Brief Summary

A double-blind randomized-controlled clinical trial is conducted in order to evaluate the impact of non-surgical periodontal treatment on endothelial dysfunction parameters in subjects with periodontitis and without any cardiovascular disease.

Condition or Disease	Intervention/Treatment	Phase
Atherosclerosis; Periodontitis	Procedure: Non-surgical periodontal treatment	N/A

Detailed Description

A double-blind randomized-controlled clinical trial is conducted in order to evaluate the impact of non-surgical periodontal treatment on endothelial dysfunction parameters in subjects with periodontitis and without any cardiovascular disease.

60 patients: 30 with periodontitis and 30 with healthy controls and without periodontitis history.

All the patients are assessed for clinical, periodontal, blood and non-invasive ultrasound cardiovascular parameters. Measurements are taken before and after initial periodontal treatment in the periodontal subjects.

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 60 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Investigator)
• Primary Purpose: Treatment
• Official Title: Impact of Non-surgical Periodontal Therapy in the Improvement of Early Endothelial Dysfunction in Subjects With Periodontitis: a Randomized-controlled Clinical Trial.
• Actual Study Start Date: Sep 7, 2020
• Anticipated Primary Completion Date: Oct 30, 2023
• Anticipated Study Completion Date: Nov 30, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Periodontitis Subjects diagnosed with periodontitis according to the most recent international guidelines and without cardiovascular diseases.	Procedure: Non-surgical periodontal treatment; Subgingival biofilm ultrasonic debridement
No Intervention: Healthy Subjects without periodontitis and with good gingival health.

Outcome Measures

Primary Outcome Measures

1. Pulse Wave Velocity carotid-femoral (PWV-CF) [8 weeks]

   The speed of pulse wave propagation between carotid-femoral sites

2. Pulse Wave Velocity carotid-femoral (PWV-CR) [8 weeks]

   The speed of pulse wave propagation between carotid-radial sites

3. Carotid Intima-Media Thickness (CIMT) [8 weeks]

   The thickness of the carotid intima and media

4. Distensibility Coefficient (DC) [8 weeks]

   The relative change in luminal area during systole for a given pressure change (pulsed pressure), will be calculated assuming the lumen to be circular.

5. Advanced Glycation End products (AGEs) [8 weeks]

   A group of endogenous heterogeneous compounds that are constantly formed under physiological conditions with prooxidant and cytotoxic properties. Measurements are performed by fluorescence spectroscopy technique.

Eligibility Criteria

Criteria

• Ages Eligible for Study: N/A and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

PERIODONTITIS GROUP

Inclusion Criteria:

• Clinically diagnosed with periodontitis according to the EFP/AAP 2017 criteria.

Exclusion Criteria:

• Periodontal treatment, antibiotics, NSAIDs, immunosuppressants during the last 6 months.

• Pregnancy.

• Cardiovascular Diseases.

HEALTHY GROUP

Inclusion Criteria:

• Clinically diagnosed with healthy periodontum withouth periodontitis history according to the EFP/AAP 2017 criteria.

Exclusion Criteria:

• Scaling, antibiotics, NSAIDs, immunosuppressants during the last 6 months.

• Pregnancy.

• Cardiovascular Diseases.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	AOU Policlinico G. Rodolico	Catania		Italy	95124

Sponsors and Collaborators

• University of Catania

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Gaetano Isola, Researcher, University of Catania
• ClinicalTrials.gov Identifier: NCT05906797
• Other Study ID Numbers: 121-22
• First Posted: Jun 18, 2023
• Last Update Posted: Jun 18, 2023
• Last Verified: Jun 1, 2023

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Periodontitis; Atherosclerosis

Study Results

No Results Posted as of Jun 18, 2023