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NCT Number: NCT06498180

Periodontal Initial Treatment Combined With Glucocorticoid Therapy for Erosive Oral Lichen Planus

The purpose of this clinical trial is to understand whether the combination of periodontal initial treatment under local anesthesia and glucocorticoids can improve the effectiveness of treatment for erosive oral lichen planus. It will also understand the safety of this treatment regimen.

This study is a single-center, parallel-group, randomized self-controlled trial. The researchers will compare the treatment of periodontal initial therapy combined with glucocorticoid therapy under local anesthesia with traditional glucocorticoid therapy to see if the treatment of periodontal initial therapy combined with glucocorticoid therapy under local anesthesia promotes the healing of erosive oral lichen planus.

Participants will:

One side received periodontal initial treatment combined with glucocorticoid under local anesthesia, while the other side received traditional glucocorticoid therapy Clinical examination at 2, 4, 8, and 12 weeks after treatment Note down the size of their erosion lesion area and periodontal clinical parameters

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Key information

Conditions

Oral Lichen Planus Lichen Planus Lichen Planus, Oral Lichenoid Eruptions Mouth Diseases Periodontal Diseases Skin Diseases Skin Diseases, Papulosquamous Skin and Connective Tissue Diseases Stomatognathic Diseases

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Existence of erosive oral lichen planus that lasts for more than 2 months
  • Erosive lesions are located in the buccal mucosa and gingival buccal sulcus of the bilateral mandibular posterior teeth area
  • The erosive lesions are mild to moderate (single or multiple small area erosions; 3mm ≤ longest diameter ≤ 10mm; 9mm2 ≤ total area of erosions ≤ 100mm2), and the degree of erosion on both sides is similar (the difference in the size of erosion on both sides does not exceed ± 25%)
  • The plaque index in the area of erosive lesions is ≥ 3; Dental calculus index ≥ 2; Gingival index ≥ 2;
  • Accompanied by stage II-IV extensive periodontitis

Exclusion criteria

  • Pregnant women, lactating women, or women planning to conceive during the trial period
  • Patients with coagulation dysfunction or other uncontrolled systemic diseases who cannot undergo periodontal treatment
  • Has undergone basic periodontal treatment within the past 6 months
  • Individuals with a history of allergy to local anesthetic drugs such as articaine
  • Individuals with contraindications to glucocorticoids
  • Patients with lesion area erosion caused by trauma or chemical stimulation
  • Patients with mental disorders who are difficult to cooperate with treatment

Treatment and study plan

Periodontal initial treatment under local anesthesia

Other

Removal of plaque retention factors, supragingival scaling and subgingival scraping under local anesthesia with articaine (combined with manual and ultrasound methods), and polishing

Glucocorticoid Therapy

Drug

Local blockade therapy with Betamethasone Sodium Phosphate Injection (containing 1.4mg Betamethasone equivalent), local use of 1% Triamcinolone Acetate Ointment, and rinsing with 1% Sodium Bicarbonate (avoiding systemic use during visits)

Oral hygiene instruction

Behavioral

Instructions and demonstrations for using manual toothbrushes Instructions and demonstrations for using dental floss or interdental brushes

Primary outcomes

  1. The erosion area of oral lichen planus

    Time frame: 3 months

    The erosion area of oral lichen planus

Secondary outcomes

  1. visual analogue scale

    Time frame: 2, 4, 8, and 12 weeks

    Mark a horizontal line of 0-10cm on paper with a ruler, and determine the score in millimeters (mm). The score range is 0-100mm, with higher scores indicating greater pain intensity

  2. Clinical score of oral lichen planus

    Time frame: 2, 4, 8, and 12 weeks

  3. probing depth

    Time frame: 4, 8, and 12 weeks

  4. clinical attachment loss

    Time frame: 4, 8, and 12 weeks

  5. plaque index

    Time frame: 4, 8, and 12 weeks

  6. Full mouth bleeding scores

    Time frame: 4, 8, and 12 weeks

Other outcomes

  1. complication

    Time frame: 2, 4, 8, and 12 weeks

    Infection, bleeding, liver and kidney damage, difficulty eating due to pain

Study contacts

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

Hong Zhen, Doctor

CONTACT

[email protected]

+86-021-53315576

Sponsors and collaborators

Lead sponsor

Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University

Other

Registry information

Official study title

A Randomized Self-control Study of Periodontal Initial Treatment Under Local Anesthesia Combined With Glucocorticoid Therapy for Erosive Oral Lichen Planus

Important dates

Study start
2024
Primary completion
2027
Study completion
2028
First posted
Jul 12, 2024
Registry last updated
Jul 12, 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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