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NCT Number: NCT06698718

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

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.

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Key information

Conditions

Periodontitis Mouth Diseases Periodontal Diseases Stomatognathic Diseases

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

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

Hangzhou, Zhejiang, China

Location status: Recruiting

Location contact

Sun

CONTACT

[email protected]

+86 0571 87783759

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

Periodontal basic treatment

Procedure

Accept periodontal basic treatment

Primary outcomes

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

    Time frame: 12 weeks after treatment

Study contacts

Contact information is provided by the study sponsor or research team.

Sun

CONTACT

[email protected]

+86 13757119563

Sponsors and collaborators

Lead sponsor

Second Affiliated Hospital, School of Medicine, Zhejiang University

Other

Registry information

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Nov 21, 2024
Registry last updated
Nov 21, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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