NCT06789458

Brief Summary

This study aims to assess Pro-Resolution Mediator levels during non-surgical periodontal therapy in individuals with Stage III and IV periodontitis, comparing them to healthy subjects. Periodontitis, a chronic inflammatory condition affecting tooth-supporting tissues, can lead to tooth loss and systemic complications. Understanding the role of pro-resolving lipid mediators in inflammation resolution may offer insights into therapeutic benefits associated with these mediators.

Trial Health

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Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
22

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Oct 2022

Typical duration for not_applicable

Geographic Reach
1 country

2 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 15, 2022

Completed
2.3 years until next milestone

First Submitted

Initial submission to the registry

January 17, 2025

Completed
6 days until next milestone

First Posted

Study publicly available on registry

January 23, 2025

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 14, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 14, 2025

Completed
Last Updated

January 23, 2025

Status Verified

January 1, 2025

Enrollment Period

3 years

First QC Date

January 17, 2025

Last Update Submit

January 17, 2025

Conditions

Peridontal Disease

Keywords

lipoxinproresolution mediators

Outcome Measures

Primary Outcomes (1)

  • Change in level of GCF lipoxin A4

    preoperative, one day, one month and 3 months postoperative

Secondary Outcomes (6)

  • Change in level of GCF Protectin

    preoperative, one day, one month and 3 months postoperative

  • Probing pocket depth (PPD)

    preoperative, and 3 months postoperative

  • Bleeding On Probing (BOP)

    preoperative, and 3 months postoperative

  • Plaque index (PI)

    preoperative, and 3 months postoperative

  • Clinical Attachment Level (CAL)

    preoperative, and 3 months postoperative

  • +1 more secondary outcomes

Study Arms (2)

Healthy Control

NO INTERVENTION

Systemically healthy patient

Periodontitis Stage III and IV

ACTIVE COMPARATOR

Professional mechanical plaque control

Procedure: Professional mechanical plaque control

Interventions

Professional mechanical plaque controlPROCEDURE

thisThe first step in therapy is aimed at guiding behavior change by motivating the patient to undertake successful removal of supragingival dental biofilm and risk factor control and may include the following interventions: * Interventions to improve the effectiveness of oral hygiene \[motivation, instructions (oral hygiene instructions, OHI) * Professional mechanical plaque removal (PMPR), which includes the professional interventions aimed at removing supragingival plaque and calculus, as well as possible plaque-retentive factors that impair oral hygiene practices. * Adjustment of faulty restoration and polishing * The mechanical plaque control instructions for each patient include brushing and interdental cleaning techniques.

Periodontitis Stage III and IV

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Adult patients above 18 years old.
  • Interdental CAL at site of greatest loss ≥5 mm or extending to middle third of the root.
  • Interdental CAL at site of greatest loss ≥8 mm or extending to apical third of the root.
  • Probing depth ≥6 mm.
  • Vertical bone loss ≥3 mm.
  • Tooth loss due to periodontitis of ≤4 teeth. (Periodontitis Stage III)
  • Tooth loss due to periodontitis of ≥5 teeth. (Periodontitis Stage IV)
  • Furcation involvement Class II or III Moderate ridge defect.

You may not qualify if:

  • \. Pregnancy or lactation. 2. Smoking more than 20 cigarettes. 3. Immuno-inflammatory conditions of the skin and oral mucosa 4. systemic conditions affecting bone turnover and periodontal health status (e.g. endocrine and connective tissue diseases, bisphosphonate antiresorptive therapy, gastrointestinal diseases related to nutrition and mineral metabolism) 5. Periodontal or orthodontic treatment at least 6 months before the start of the study 6. Use of anti-inflammatory and antimicrobial agents within 3 months before sampling
  • Systemically healthy patients.
  • Patients with an age range between 16 to 80 years.
  • Patients have a minimum of 20 teeth.
  • Less than 10% bleeding sites with probing depths ≤3 mm.
  • absence of erythema, oedema.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Faculty of Dentistry-Cairo University

Manial, Cairo Governorate, 12311, Egypt

RECRUITING

faculty of dentistry Cairo university

Cairo, Egypt

RECRUITING

Related Links

Central Study Contacts

Husam Ghazi Alharbi, Master Degree

CONTACT

+201222284055husam.ghazi@dentistry.cu.edu.eg

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Husam Ghazi Dwerj Alharbi

Study Record Dates

First Submitted

January 17, 2025

First Posted

January 23, 2025

Study Start

October 15, 2022

Primary Completion

October 14, 2025

Study Completion

October 14, 2025

Last Updated

January 23, 2025

Record last verified: 2025-01

Data Sharing

IPD Sharing
Will not share

Locations

EG(2)