NCT06539364

Brief Summary

In this study, the quality of life of patients with stage 3 grade C periodontitis who underwent surgical and non-surgical periodontal treatments was evaluated. Patients were compared based on their quality of life using OHIP-14 and OHRQoL-UK questionnaires, as well as a VAS scale, against those who did not receive periodontal treatment, those who received only phase 1 treatment one month prior, and those who underwent periodontal surgical treatment three months prior.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
50

participants targeted

Target at P25-P50 for not_applicable quality-of-life

Timeline
Completed

Started Aug 2019

Typical duration for not_applicable quality-of-life

Geographic Reach
1 country

1 active site

Status
completed

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

August 8, 2019

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 18, 2020

Completed
10 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 5, 2021

Completed
2.8 years until next milestone

First Submitted

Initial submission to the registry

July 17, 2024

Completed
20 days until next milestone

First Posted

Study publicly available on registry

August 6, 2024

Completed
Last Updated

August 7, 2024

Status Verified

August 1, 2024

Enrollment Period

1.4 years

First QC Date

July 17, 2024

Last Update Submit

August 6, 2024

Conditions

Keywords

periodontitisquality of lifeVASOHIP-14OHRQoL-UK

Outcome Measures

Primary Outcomes (1)

  • obtain survey results

    obtaining survey results to see the impact on patients' quality of life

    Baseline (T1), 3 weeks after non-surgical periodontal treatment (T2), and 12 weeks after surgical periodontal treatment (T3).

Study Arms (2)

NON-SURGICAL PERIODONTAL TREATMENT

ACTIVE COMPARATOR

Patients included in this group underwent full-mouth scaling followed by root planning in the necessary areas. At the 3-week follow-up session, periodontal surgery was not planned. Periodontal records were maintained, and surveys were administered at follow-up visits.

Diagnostic Test: Quality of life surveys were conducted

SURGICAL PERIODONTAL TREATMENT

EXPERIMENTAL

Patients included in this group received full-mouth scaling followed by root planning in the necessary areas. After a 3-week follow-up period, periodontal records were taken and surgical periodontal treatment was administered to the required areas. Periodontal records were maintained and surveys were conducted at follow-up visits.

Diagnostic Test: Quality of life surveys were conducted

Interventions

Quality of life surveys were conducted with OHIP-14, OHRQoL-UK and VAS

NON-SURGICAL PERIODONTAL TREATMENTSURGICAL PERIODONTAL TREATMENT

Eligibility Criteria

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

You may qualify if:

  • Literate
  • Over 18 years of age
  • Willing to voluntarily participate in the study
  • No mental retardation or any other disorder that would impede communication

You may not qualify if:

  • Presence of any systemic disease affecting periodontal tissues or use of medication that impacts periodontal health
  • Pregnancy or lactation
  • Having undergone periodontal treatment in the past 6 months

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Izmir Katip Çelebi University Department of Periodontology

Izmir, Çiğli, 35640, Turkey (Türkiye)

Location

Related Publications (1)

  • Gerzile A, Naziker Y, Ozer E, Ertugrul AS. Impact of Surgical and Non-Surgical Periodontal Therapy on Quality of Life in Case of Periodontitis. Oral Dis. 2025 Aug;31(8):2564-2571. doi: 10.1111/odi.15316. Epub 2025 Mar 19.

MeSH Terms

Conditions

Periodontitis

Condition Hierarchy (Ancestors)

Periodontal DiseasesMouth DiseasesStomatognathic Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Model Details: According to full-mouth clinical periodontal measurements including probing depth (PD), clinical attachment level (CAL),bleeding on probing (BOP), gingival index (GI) and plaque index (PI) were obtained from 50 systemically healthy individuals with periodontitis and after the initial treatment repeat measurements were taken at the control session to evaluate participation in the surgical treatment group.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Research Assistant

Study Record Dates

First Submitted

July 17, 2024

First Posted

August 6, 2024

Study Start

August 8, 2019

Primary Completion

December 18, 2020

Study Completion

October 5, 2021

Last Updated

August 7, 2024

Record last verified: 2024-08

Data Sharing

IPD Sharing
Will share
Shared Documents
STUDY PROTOCOL, SAP, ICF

Locations