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Impact of Non-surgical Periodontal Therapy in the Improvement of Early Endothelial Dysfunction in Subjects With Peri-implantitis and Peri-implant Mucositis

Sponsor
University of Catania (Other)
Overall Status
Recruiting
CT.gov ID
NCT05906810
Collaborator
(none)
90
Enrollment
1
Location
3
Arms
38.5
Anticipated Duration (Months)
2.3
Patients Per Site Per Month

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 peri-implantitis/peri-implant mucositis and without any cardiovascular disease.

Condition or Disease Intervention/Treatment Phase
  • 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 peri-implantitis/peri-implant mucositis and without any cardiovascular disease.

90 patients: 30 with peri-implantitis, 30 with peri-implant mucositis and 30 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 peri-implantitis/peri-implant mucositis subjects.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
90 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
The main objective of this study is to evaluate the efficacy of periodontal treatment on the improvement in cardiovascular parameters.The main objective of this study is to evaluate the efficacy of periodontal treatment on the improvement in cardiovascular parameters.
Masking:
Triple (Participant, Care Provider, Investigator)
Masking Description:
Sealed envelopes
Primary Purpose:
Treatment
Official Title:
Impact of Non-surgical Periodontal Therapy in the Improvement of Early Endothelial Dysfunction in Subjects With Peri-implantitis and Peri-implant Mucositis: a Randomized-controlled Clinical Trial.
Actual Study Start Date :
Oct 5, 2020
Anticipated Primary Completion Date :
Nov 20, 2023
Anticipated Study Completion Date :
Dec 20, 2023

Arms and Interventions

Arm Intervention/Treatment
Experimental: Peri-implantitis

Subjects diagnosed with peri-implantitis according to the most recent international guidelines and without cardiovascular diseases.

Procedure: Non-surgical periodontal treatment
Subgingival biofilm ultrasonic debridement
Active Comparator: Peri-implant mucositis

Subjects diagnosed with peri-implant mucositis 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

PERI-IMPLANTITIS GROUP

Inclusion Criteria:

• Clinically diagnosed with peri-implantitis according to the EFP/AAP 2017 criteria.

Exclusion Criteria:

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

  • Pregnancy.

  • Cardiovascular Diseases.

PERI-IMPLANT MUCOSITIS GROUP

Inclusion Criteria:

• Clinically diagnosed with peri-implant mucositis according to the EFP/AAP 2017 criteria.

Exclusion Criteria:

  • Periodontal treatment, implant surgery, 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:
NCT05906810
Other Study ID Numbers:
  • 121-23
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:
Mucositis
Peri-Implantitis
Atherosclerosis

Study Results

No Results Posted as of Jun 18, 2023