An interventional study of Periodontal initial treatment under local anesthesia and Glucocorticoid Therapy in Oral Lichen Planus and Periodontal Diseases, sponsored by Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University. Not yet recruiting at 1 site in China. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2024-07-12.
Sponsored by Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University · Not applicable, Interventional, and Treatment
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
142 studies on the registry are indexed under Lichen Planus, Oral; 27 are open to participants now.
This study's planned enrollment of 29 is below the median of 39 across 101 interventional studies indexed under Lichen Planus, Oral.
Browse Lichen Planus, Oral studies →Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University is the lead sponsor of 164 studies on the registry; 73 are open to participants now.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
In the experimental group, subjects will undergo periodontal initial treatment under local anesthesia combined with glucocorticoid local blockade therapy (such as triamcinolone acetonide injection), local use of triamcinolone acetonide ointment, and 1% sodium bicarbonate rinse (avoiding systemic use during visits) after baseline examination, while receiving the following professional oral hygiene guidance: Instructions and demonstrations for using manual toothbrushes Instructions and demonstrations for using dental floss or interdental brushes A periodontist with rich clinical experience will perform periodontal initial treatment under local anesthesia.
Other: Periodontal initial treatment under local anesthesia · Drug: Glucocorticoid Therapy · Behavioral: oral hygiene instruction
In the control group, participants will undergo routine glucocorticoid local blockade therapy (such as triamcinolone acetonide injection), local administration of triamcinolone acetonide ointment, and 1% sodium bicarbonate rinse (avoiding systemic medication during visits) after baseline examination, while receiving the following professional oral hygiene guidance: Instructions and demonstrations for using manual toothbrushes Instructions and demonstrations for using dental floss or interdental brushes Based on ethical considerations, all participants will receive full mouth periodontal initial treatment at the end of the trial.
Drug: Glucocorticoid Therapy · Behavioral: oral hygiene instruction
Removal of plaque retention factors, supragingival scaling and subgingival scraping under local anesthesia with articaine (combined with manual and ultrasound methods), and polishing
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)
Instructions and demonstrations for using manual toothbrushes Instructions and demonstrations for using dental floss or interdental brushes
The erosion area of oral lichen planus
The erosion area of oral lichen planus
Time frame: 3 months
visual analogue scale
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
Time frame: 2, 4, 8, and 12 weeks
Clinical score of oral lichen planus
Time frame: 2, 4, 8, and 12 weeks
probing depth
Time frame: 4, 8, and 12 weeks
clinical attachment loss
Time frame: 4, 8, and 12 weeks
plaque index
Time frame: 4, 8, and 12 weeks
Full mouth bleeding scores
Time frame: 4, 8, and 12 weeks
complication
Infection, bleeding, liver and kidney damage, difficulty eating due to pain
Time frame: 2, 4, 8, and 12 weeks
Plan to share: No
No publications or documents are linked to this record.
Start is estimated for Dec 2024; primary completion for Dec 2027, 36 months later.
Of 20 interventional studies with no phase under Lichen Planus, Oral, half reached primary completion within 14 months of starting (the median), counting those still running; a quarter within 9 and three quarters within 27. This study's planned 36 months is above that.
How these figures are worked out, and which studies are left out of them.
This study is not yet recruiting, as verified in Apr 2024. You cannot join it, but the record below documents what was studied.
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Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University →