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

Periodontitis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06143085
• Other study ID #: 663622
• Status: Recruiting
• Phase: N/A
• Start date: October 10, 2022
• Est. completion date: January 20, 2024

Study information

• Verified date: November 2023
• Source: University of Baghdad
• Contact: Ali A Abdulkareem, PhD
• Phone: 07806866717
• Email: ali.abbas[@]codental.uobaghdad.edu.iq
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 72
• Est. completion date: January 20, 2024
• Est. primary completion date: December 20, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Periodontitis

Intervention

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)

Locations

Country	Name	City	State
Iraq	College of Dentistry/ University of Baghdad	Baghdad

Sponsors (1)

Lead Sponsor	Collaborator
University of Baghdad

Country where clinical trial is conducted

Iraq, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Bleeding on probing	Sign of bleeding after gentle probing of the sulcus/periodontal pocket	Baseline and 3 months after treatment
Secondary	Clinical attachment level	The distance from the CEJ to the base of the sulcus/pocket	Baseline and 3 months after treatment
Secondary	Oral Health Impact Profile-14	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