NCT05812391

Brief Summary

Periodontitis (PD) is an inflammatory condition that affects 20%-50% of the total global population, with severe disease occurring in 9.8% of individuals. clinically characterized by clinical attachment loss (CAL) and bleeding on probing (BOP) accompanied by increased probing pocket depth (PPD) and/or gingival recession, it may end with tooth loss if left untreated. non-surgical periodontal treatment (NSPT) represents the first line of treatment and involves the physical debridement of subgingival plaque biofilms. "full-mouth debridement" (FMD) approach, its NSPT delivers complete debridement within 24 hr. However, full-mouth NSPT has been consistently shown to trigger a large systemic inflammatory response 24 hr following treatment. Nevertheless, Interestingly, a positive correlation between treatment time and the subsequent systemic inflammatory response has been reported. Given this previous link and the different features of each instrumentation technique including air-polishing devices (APDs), that have less time-consuming treatment, reduce patient discomfort and sensitivity, and only minor alterations to surrounding soft and hard tissues. This study aims to evaluate the systemic inflammatory response following full-mouth erythritol powder air polishing and instrumentation.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
42

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Mar 2023

Geographic Reach
1 country

1 active site

Status
unknown

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 10, 2023

Completed
23 days until next milestone

First Submitted

Initial submission to the registry

April 2, 2023

Completed
11 days until next milestone

First Posted

Study publicly available on registry

April 13, 2023

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2024

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2024

Completed
Last Updated

April 19, 2023

Status Verified

April 1, 2023

Enrollment Period

12 months

First QC Date

April 2, 2023

Last Update Submit

April 16, 2023

Conditions

Periodontal Diseases

Keywords

Periodontal diseasePeriodontitisAir abrasionTooth polishingAir-polishing

Outcome Measures

Primary Outcomes (1)

  • Change in serum level of C-reactive protein

    Change in serum level of C-reactive protein 24 hours following the full mouth debridement

    24 hours

Secondary Outcomes (5)

  • Treatment time

    30 days

  • Change in percentage of bleeding on probing

    30 days

  • Change in mean probing pocket depth

    30 days

  • Change in clinical attachment loss

    30 days

  • Change in percentage of plaque index

    30 days

Study Arms (2)

test group

ACTIVE COMPARATOR

Supra-gingival erythritol powerder air polishing Sub-gingival erythritol powerder air polishing Supra-gingival debridement Sub-gingival debridement

Procedure: test

conventional group

ACTIVE COMPARATOR

Supra-gingival debridement Sub-gingival debridement Polishing with polishing paste

Procedure: conventional

Interventions

testPROCEDURE

the treatment start with supra-gingival erythritol powerder air polishing followed by sub-gingival erythritol powerder air polishing,supra-gingival debridement and sub-gingival debridement

test group
conventionalPROCEDURE

the treatment start with supra-gingival debridement followed by sub-gingival debridement then finished with polishing paste

conventional group

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Participants who have periodontitis, unstable, at any stage

You may not qualify if:

  • Participants who are known or suspected high risk for tuberculosis
  • Participants who have hepatitis B or HIV infections
  • Participants who are being unable to provide written, informed consent
  • Participants who have history of bleeding diathesis
  • Participants who are pregnant or intended to and lactating mother.
  • Participants who are self-reported diagnosis of any systemic illnesses including cardiovascular, renal and liver diseases
  • Participants who have regular use of medication to control systemic illness.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mohammed Kalid Ayoob

Baghdad, 10053, Iraq

Location

MeSH Terms

Conditions

Periodontal DiseasesPeriodontitis

Interventions

Congresses as Topic

Condition Hierarchy (Ancestors)

Mouth DiseasesStomatognathic Diseases

Intervention Hierarchy (Ancestors)

OrganizationsHealth Care Economics and Organizations

Study Officials

  • Mohammed K Ayoob

    University of Baghdad

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
SCREENING
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal investigator

Study Record Dates

First Submitted

April 2, 2023

First Posted

April 13, 2023

Study Start

March 10, 2023

Primary Completion

March 1, 2024

Study Completion

October 1, 2024

Last Updated

April 19, 2023

Record last verified: 2023-04

Data Sharing

IPD Sharing
Will not share

Locations

IR(1)