Application of CIELab Spectrophotometry to Analyze Gingival Color: a New Perspective for Evaluating the Effectiveness of Periodontal Basic Treatment

NCT ID: NCT06698718

Last Updated: 2024-11-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-10-18

Study Completion Date

2025-03-01

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Periodontitis

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Treatment group

Group Type EXPERIMENTAL

Periodontal basic treatment

Intervention Type PROCEDURE

Accept periodontal basic treatment

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Periodontal basic treatment

Accept periodontal basic treatment

Intervention Type PROCEDURE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

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

Exclusion Criteria

1. Cardiac function levels III and IV
2. Blood pressure\>180/110 mmHG
3. Pregnant women, women in pregnancy or lactation
4. 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
5. 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
6. Patients with malignant tumors or undergoing radiotherapy, chemotherapy, and targeted drug therapy
7. Patients with pacemakers who cannot undergo ultrasound therapy
8. Smoking or quitting smoking for less than 5 years
9. Individuals with abnormalities such as pigment deposition and keratinized beads in the front teeth and gums
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Second Affiliated Hospital, School of Medicine, Zhejiang University

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

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

Hangzhou, Zhejiang, China

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

China

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Sun

Role: CONTACT

+86 13757119563

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Sun

Role: primary

+86 0571 87783759

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

2023-0935

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.