Impact of Nonsurgical Periodontal Therapy on Oral Health Related Quality of Life

November 19, 2023 updated by: Ali A Abdulkareem, University of Baghdad

Impact of Nonsurgical Periodontal Therapy for Stage 2 and 3 Periodontitis on Oral Health Related Quality of Life: A Clinical Trial

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Periodontitis is a chronic disease characterized by progressive loss of tooth-supporting tissues. It is adversely affecting function, esthetic, and general wellbeing. Oral health related quality of life (OHRQoL) is the part of quality of life which is affected by oral cavity-related status. Majority of clinical studies emphasize on periodontal outcomes after periodontal therapy. However, tangible outcomes perceived by the patient such as need for re-treatment, tooth survival, and OHRQoL are mostly neglected. OHRQoL is mainly measured by using self-reported questionnaires and the most commonly used one is Oral Health Impact Profile (OHIP).

Nonsurgical periodontal therapy (NSPT) is the gold-standard technique for treating shallow to moderately deep periodontal pockets. The principle of this technique is based on mechanically disrupting subgingival dysbiotic biofilm, consequently; restoring homeostasis and healthy state of periodontal tissues. Indeed, halting progressive periodontitis is a major contributor for improving oral health and increasing tooth survival rate which are positively perceived by the patients. Previous studies consistently reporting improvement of OHRQoL following periodontal treatment. Therefore, this study aimed to investigate the impact of NSPT on OHRQoL for Stage (S)2 and S3 periodontitis patient and the factors predicting the outcomes.

Study Type

Interventional

Enrollment (Estimated)

72

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Generalized periodontitis
Patients diagnosed with generalized periodontitis of different severities exhibiting periodontal pockets not exceeding 6mm.
Procedure: Root surface debridement
Periodontitis patients are treated non-surgically by supra- and subgingival debridement followed by root surface debridement for moderately deep periodontal pockets (4 to 6mm)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Probing pocket depth
Time Frame: PPD is assessed at baseline and 3 months after treatment
The distance from the gingival margin to the base of the sulcus/pocket
PPD is assessed at baseline and 3 months after treatment

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Bleeding on probing
Time Frame: Baseline and 3 months after treatment
Sign of bleeding after gentle probing of the sulcus/periodontal pocket
Baseline and 3 months after treatment
Clinical attachment level
Time Frame: Baseline and 3 months after treatment
The distance from the CEJ to the base of the sulcus/pocket
Baseline and 3 months after treatment
Oral Health Impact Profile-14
Time Frame: Baseline and 3 months after treatment
A questionnaire designed to determine oral health related quality of life consists of seven domains reflecting Functional limitation, Physical pain, Psychological discomfort, Physical disability, Psychological disability, Social disability, Handicap. Each domain composed of two questions and the scores calculation are based on a Likert scale (Never, Hardly ever, Occasionally, Often, Very often) which receive scores from 0 to 4. The higher total scores indicate worse oral health related quality of life
Baseline and 3 months after treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Baghdad

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 10, 2022

Primary Completion (Estimated)

December 20, 2023

Study Completion (Estimated)

January 20, 2024

Study Registration Dates

First Submitted

November 14, 2023

First Submitted That Met QC Criteria

November 19, 2023

First Posted (Estimated)

November 22, 2023

Study Record Updates

Last Update Posted (Estimated)

November 22, 2023

Last Update Submitted That Met QC Criteria

November 19, 2023

Last Verified

November 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 663622

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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