NCT06143085

Brief Summary

Periodontitis is a destructive inflammatory disease of tooth supporting tissues and it adversely affects oral and general health as well as lowering the quality of life. Nonsurgical periodontal therapy is a gold standard technique for treating mild to moderate periodontitis and it was reported to significantly improve oral health related quality of life.

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
72

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Oct 2022

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 10, 2022

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

November 14, 2023

Completed
8 days until next milestone

First Posted

Study publicly available on registry

November 22, 2023

Completed
28 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 20, 2023

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

January 20, 2024

Completed
Last Updated

November 22, 2023

Status Verified

November 1, 2023

Enrollment Period

1.2 years

First QC Date

November 14, 2023

Last Update Submit

November 19, 2023

Conditions

Periodontitis

Outcome Measures

Primary Outcomes (1)

  • Probing pocket depth

    The distance from the gingival margin to the base of the sulcus/pocket

    PPD is assessed at baseline and 3 months after treatment

Secondary Outcomes (3)

  • Bleeding on probing

    Baseline and 3 months after treatment

  • Clinical attachment level

    Baseline and 3 months after treatment

  • Oral Health Impact Profile-14

    Baseline and 3 months after treatment

Study Arms (1)

Generalized periodontitis

EXPERIMENTAL

Patients diagnosed with generalized periodontitis of different severities exhibiting periodontal pockets not exceeding 6mm.

Procedure: Root surface debridement

Interventions

Root surface debridementPROCEDURE

Periodontitis patients are treated non-surgically by supra- and subgingival debridement followed by root surface debridement for moderately deep periodontal pockets (4 to 6mm)

Generalized periodontitis

Eligibility Criteria

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

You may qualify if:

  • Adults (\>18 years)
  • Not reporting history of any systemic disease
  • Non-smoker
  • Can read and understand the questionnaire.

You may not qualify if:

  • Patients with depression or any psychological issues
  • Those not willing to participate

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

College of Dentistry/ University of Baghdad

Baghdad, Iraq

RECRUITING

MeSH Terms

Conditions

Periodontitis

Condition Hierarchy (Ancestors)

Periodontal DiseasesMouth DiseasesStomatognathic Diseases

Central Study Contacts

Ali A Abdulkareem, PhD

CONTACT

07806866717ali.abbas@codental.uobaghdad.edu.iq

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

November 14, 2023

First Posted

November 22, 2023

Study Start

October 10, 2022

Primary Completion

December 20, 2023

Study Completion

January 20, 2024

Last Updated

November 22, 2023

Record last verified: 2023-11

Locations

IR(1)