HKUCTR

HKU CLINICAL TRIALS REGISTRY
 

Study Registration and Background Information
Study Identifier: HKUCTR-1848
Date of Study Registration: 27 Jul 2014
Official Scientific Title of Study: Adjunctive effect of a Chinese herbal medicine in the treatment of advanced periodontal disease: A randomized controlled clinical trial
Brief Title of Study (if applicable): Modified Junu-Jian adjunct periodontal therapy
Protocol No.: N/A
Research Ethics Approval/ Ref. No.: Yes / 1/8/12d
Regulatory Approval/ Ref. No. (if applicable): N/A
Anticipated Study Start Date: Feb 2004
Study Status: Completed / Terminated
Study Type, Design and Methodology
Study Type:
Interventional
Prospective and Randomized controlled trial
Study Design:
Methods of Assignment:
Randomization
Degree of Masking
Group Assignment
Phase of Study
Double-blinded
Parallel
N/A
Disease Area: Mouth and tooth
Medical Conditions: chronic peridontitis
smoker
Intervention:
Type
Name
Duration
Complementary medicine
modified Yunu-Jian TCM decoction
N/A
Control: N/A
Primary Outcome: alveolar bone density
Secondary Outcomes: probing pocket depth
probing attachment level
Inclusion Criteria: 1. Heavy smoker with at least of 5 pack year level of exposure (e.g. 20 cigarettes/day and persisted in this pattern for 5 years or 10 cigarettes/day and persisted in this pattern for 10 years) 2. 35 to 60 years-old ethnic Chinese with moderate-to-advanced chronic periodontitis 3. Minimum of 16 standing teeth (excluding third molars) with at least two teeth in each quadrant having a PPD ≥ 5mm and bleeding on probing. 4. Radiographic evidence of alveolar bone loss in at least two teeth 5. Having syndrome of deficiency of kidney-yin and stomach-heat as judged by a traditional Chinese medical doctor according to Traditional Chinese Medicine (TCM) principles.
Exclusion Criteria: 1. Presence of systemic diseases 2. Have used antibiotics or antiseptics for at least 3 months 3. History of periodontal treatment except for oral hygiene instruction and supra-gingival scaling in the previous year 4. History of rheumatic fever or other conditions that indicate antibiotic prophylaxis prior to invasive dental treatment to be needed. 5. Presence of systemic medical conditions known to be associated with periodontal condition. 6. Undergoing any therapy such as orthodontic treatment which will move the position of the tooth. 7. Pregnant or nursing mother 8. Being found by a traditional Chinese medical doctor to be unsuitable to take the Chinese herbal medicine used in the study.
Target Sample Size:
No. of subjects to be recruited at local site:
32
Site of Recruitment: Faculty of Dentistry
Prince Philip Dental Hospital
Contact Information
Principal Investigator:
Name:
Dr. Kwan-Yat Zee
Department/Unit:
Faculty of Dentistry
Tel:
2859-0300
General Enquiries:
Name:
HKUCTR Administrator
Address:
Clinical Trials Centre, 6/F, Block T, Queen Mary Hospital, 102 Pokfulam Road, Hong Kong
Tel:
2255 2548
Sponsor & Funding Support
Primary Sponsor: Eu Yan Sang (Hong Kong) Ltd
Sources of Funding:
Type
Supporting Organization
Commercial
Eu Yan Sang (Hong Kong) Ltd
Non-commercial
Chinese Medicine Research Fund, Managing Board, Hong Kong Baptist Hospital