Centre For Clinical Research And Biostatistics (CCRB)

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1 Unique Trial Number (assigned by CCRB)

CUHK_CCT00450

2 Trial Registration Date

2015-03-26

i Registration Status

Prospective

3 Secondary IDs

CREC 2014.207-T

4 Source(s) of Funding

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

5 Primary Sponsor

Dr Regina Wing Shan SIT

6 Secondary Sponsor

nil

Function

Please specify

7 Responsible Contact Person (public contact person for patients interested in participating)

i Name

Wing Yin TAM

ii Address

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

iii Phone

25039053

iv Email

wingyintam@cuhk.edu.hk

v Affiliation

The Chinese University of Hong Kong

vi Country

8 Research Contact Person (person to contact for scientific inquiries)

i Name

Dr Regina Wing Shan SIT

ii Address

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

iii Phone

25039053

iv Email

reginasit@cuhk.edu.hk

v Affiliation

The Chinese University of Hong Kong

vi Country

9 Official Scientific Title of the Study

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

10 Public Title

Efficacy of hypertonic dextrose prolotherapy in the treatment of temporomandibular dysfunction

i Public Title in Chinese 研究名稱

葡萄糖注射對顳顎關節障礙的治療成效

11 Short Title (Optional)

Dextrose injection to temporomandibular joint

12 Countries of Recruitment

Hong Kong

13 Research Ethic Review

i Has the study received appropriate ethics approval?

Yes

ii When is the approval date?

2014-05-07

iii Full Name of IRB/IEC

Please specify

iv IRB/IEC approval reference number

14 Medical Condition Being Studied

Temporomandibular dysfunction

15 Intervention

i Types of intervention

Procedure

Please specify

ii Description/ name of Intervention/article

1 ml 20% dextrose with 0.2% lidocaine

iii Dosage form of the intervention

iv Dosage of the intervention

v Duration of the intervention

13 weeks

vi Frequency of the intervention

16 Comparative Treatments

i Description/ name of comparative treatments

1 ml of normal saline with 0.2 % lidocaine

ii Dosage form of the comparative treatments

iii Dosage of the comparative treatments

iv Duration of the comparative treatments

v Frequency of the comparative treatments

17 Key Inclusion and Exclusion Criteria

i Inclusion Criteria

-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

ii Exclusion Criteria

- 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

iii Age Minimum

18

iv Age Maximum

75

v Gender

Both Male and Female

18 Study Type

Interventional

19 Study Design

i Randomization

Randomized

Please specify

ii Nature of control

Placebo

iii Degree of masking

Double-blind

If Single-blind, who will be masked?

iv Group Assignment

Parallel

v Study Phase

Please specify

vi Study Objectives (Optional)

20 Anticipated trial start date

2015-07-01

21 Target Sample Size

40

22 Recruitment Status

Not Yet Recruiting

23 Primary Outcome

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

24 Secondary Outcome

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

25 Study Information/Publication

i Study Information/Publication Available?

No

ii Link to Study Information/Publication

26 Last Update Date

2018-04-09

27 Primary Registry and Trial Identifying Number

ChiCTR-IOR-15006158

28 Date of Registration in Primary Registry

2015-03-28

* Legacy Fields

i Recruitment Information Available?

Yes

ii Link to Recruitment Information

not applicable

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Trial History Detail on 2015-05-20