NCT06698718

Brief Summary

Objective: This study aims to explore the correlation between gingival color and clinical indicators and inflammatory factors in patients with periodontitis. Method: This study aims to include 30 periodontitis patients who visited the Periodontology Department of the Second Affiliated Hospital of Zhejiang University School of Medicine from October 2024 to November 2024. The study adopted a self controlled before and after design. All subjects received periodontal basic treatment. Record the age, gender, ethnicity, skin color, and gingival biotype of the subjects. Before treatment, 6 weeks after treatment, and 12 weeks after treatment, check and record the blood routine, high-sensitivity C-reactive protein (Hs CRP), and interleukin-6 (IL-6) of all subjects. Use a moisture absorbing paper tip to collect the gingival crevicular fluid of the subjects, and further detect the levels of interleukin-17 (IL-17) and tumor necrosis factor alpha (TNF - α) in the gingival crevicular fluid samples, and record the periodontal table. Check and record the CIE indicators L \*, a \*, b \*, probing depth (PD), gingival bleeding index (SBI), and clinical attachment loss (CAL) in the keratinized gingival area of all subjects before and after treatment at 2, 6, and 12 weeks. Analyze and compare the changes in each group's data before and after treatment.

Trial Health

57
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Oct 2024

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

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

October 18, 2024

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

November 19, 2024

Completed
2 days until next milestone

First Posted

Study publicly available on registry

November 21, 2024

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2025

Completed
Last Updated

November 21, 2024

Status Verified

November 1, 2024

Enrollment Period

4 months

First QC Date

November 19, 2024

Last Update Submit

November 19, 2024

Conditions

Periodontitis

Keywords

periodontitisPeriodontal basic treatmentSpectrophotometer colorimeter

Outcome Measures

Primary Outcomes (1)

  • CIE indicators L *, a *, b for keratinized gingival area in the anterior teeth region*

    12 weeks after treatment

Study Arms (1)

Treatment group

EXPERIMENTAL
Procedure: Periodontal basic treatment

Interventions

Periodontal basic treatmentPROCEDURE

Accept periodontal basic treatment

Treatment group

Eligibility Criteria

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

You may qualify if:

  • Patients of Han ethnicity, aged between 18 and 65 years old, diagnosed with periodontitis
  • I haven't received any periodontal basic treatment, including scaling, scraping, flap surgery, etc., for the past six months
  • The anterior teeth area has not undergone periodontal surgery or coronal restoration within six months
  • The patient has clear thinking, unobstructed communication, and high compliance

You may not qualify if:

  • Cardiac function levels III and IV
  • Blood pressure\>180/110 mmHG
  • Pregnant women, women in pregnancy or lactation
  • Those who are currently taking anticoagulant drugs, calcium channel blockers, immunosuppressants, angiotensin and other medications, receiving bisphosphonates treatment, or have a history of antibacterial treatment within 3 months
  • Uncontrolled and stable patients with systemic diseases, such as progressive liver diseases, infectious diseases, renal failure, rheumatoid diseases, blood system diseases, osteoporosis, AIDS, mental diseases and diabetes, etc
  • Patients with malignant tumors or undergoing radiotherapy, chemotherapy, and targeted drug therapy
  • Patients with pacemakers who cannot undergo ultrasound therapy
  • Smoking or quitting smoking for less than 5 years
  • Individuals with abnormalities such as pigment deposition and keratinized beads in the front teeth and gums

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

2 nd Affiliated Hospital, School of Medicine, Zhejiang University, China

Hangzhou, Zhejiang, China

RECRUITING

MeSH Terms

Conditions

Periodontitis

Condition Hierarchy (Ancestors)

Periodontal DiseasesMouth DiseasesStomatognathic Diseases

Central Study Contacts

Sun

CONTACT

+86 13757119563weiliansun@zju.edu.cn

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 19, 2024

First Posted

November 21, 2024

Study Start

October 18, 2024

Primary Completion

March 1, 2025

Study Completion

March 1, 2025

Last Updated

November 21, 2024

Record last verified: 2024-11

Locations

CN(1)