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Trial History Detail on 2015-03-27

CUHK_CCT00450

2015-03-26

Prospective

CREC 2014.207-T

investigator initiated study
Divison of Family Medicine and Primary Health Care, The Jockey Club School of Public Health and Primary Care, The Chinese University of Hong Kong

Dr Regina Wing Shan SIT

nil

Wing Yin TAM

Room 04, 4/F, Lek Yuen Health Centre, 9 Lek Yuen Street, Shatin, N.T., Hong Kong

25039053

wingyintam@cuhk.edu.hk

The Chinese University of Hong Kong

Dr Regina Wing Shan SIT

Room 17A, 4/F, Lek Yuen Health Centre, 9 Lek Yuen Street, Shatin, N.T., Hong Kong

25039053

reginasit@cuhk.edu.hk

The Chinese University of Hong Kong

Efficacy of hypertonic dextrose prolotherapy in the treatment of temporomandibular dysfunction with: A randomized controlled clinical trial

Efficacy of hypertonic dextrose prolotherapy in the treatment of temporomandibular dysfunction

葡萄糖注射對顳顎關節障礙的治療成效

Dextrose injection to temporomandibular joint

Hong Kong

Yes

2014-05-07

Temporomandibular dysfunction

Procedure

1 ml 20% dextrose with 0.2% lidocaine

13 weeks

1 ml of normal saline with 0.2 % lidocaine

-adults ≥ 18 years old who complain of pain in the face for more than 6 months and have at least one of the following symptoms referable to the jaw:
difficulty chewing
 stiffness in the jaw
 tension in the jaw
 fatigue with eating or grinding of teeth
-All the recruited participants should have their average numerical rating scale (NRS) > 5 for both facial pain and jaw dysfunction in the past 6 months

- Previous jaw operation
- Pregnancy
- Patients on anti-coagulant therapy
- Prior TMJ prolotherapy
- AnyTMJ injections within 3 months
- Co-morbidity severe enough to prevent participation in the study protocol like attendance at scheduled injection appointments
- Unable to understand or to give consent

18

75

Both Male and Female

Interventional

Randomized

Placebo

Double-blind

Parallel

2015-07-01

40

Not Yet Recruiting

Nurmerical rating scale (NRS) in the face and the NRS for jaw dysfunction at week 1, week 13 and at 1 year.

The secondary outcome will be the change in maximal mouth opening (MMO) in centimeter and “end feel” of the TMJ (hard or soft).

No

2018-04-09

ChiCTR-IOR-15006158

2015-03-28


Yes

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