Preliminary Registration Detail

Research Registry No : PLRID-00996_V1
 
Postgraduate Research : local
 
Name of University : University Of Dental Medicine, Mandalay
 
Degree : B.D.S., Dip.D.Sc
 
University Departmental Research : Yes
 
Name of University : University of dental medicine , Mandalay
 
Department : Periodontology
 
Registration Date : 2020-12-02
 
Principle Investigator : Dr.Hein Min Zaw
 
Co-Investigators : Dr Soe Tun , Dr Kyaw Thiha , Dr Ye Myat Hein, Dr Yin Mu Thet, Dr Zar Zar Lin, Dr Win Ngu Wah
 
Title of Research : Clinical effect of locally delivered 4% Garcinia mangostana gel as an adjunct to non-surgical treatment of chronic periodontitis
 
Field of Research : Dentistry
 
Preliminary Research Design : Experimental Study
 
Preliminary Research Type : Applied
 
Preliminary Justification : Non-surgical periodontal therapy (NSPT) has evolved over the years and it is still considered to be the gold standard. However, conventional mechanical debridement (scaling and root planing) do not remove all periodontopathic bacteria from subgingival environment. Therefore, local drug delivery into periodontal pocket as an adjunct to scaling and root planing has been used as a complement to NSPT. Pharmacologically active phytochemicals are widely useful for prevention, treatment and maintenance of periodontal disease. Various herbal formulations like mangosteen, aloe vera, neem, tulsi, propolis, promegnate, etc are being used widely in dentistry. These products have shown promising result with few side effects and are economical as well. Garcinia mangostana has been used for many years as a medicine for treatment of skin infection, wounds, diarrhea, malaria, aphtous ulcer due to its anti-inflammatory, antibacterial, antifungal, antimalarial, antioxidant properties. Currently, synthetic locally delivered agents like PerioChip (subgingival chlorhexidine), and Artidox (10% doxycycline gel) are still expensive and have some side effects. If 4% GM gel can improve periodontal condition as an adjunct to non-surgical periodontal therapy, it would be beneficial in periodontal management of chronic periodontitis with deep pockets as GM gel is easily accessible, economically acceptable and fewer side effects.
 
Preliminary Aim : To assess the clinical effect of locally delivered 4% Garcinia mangostana gel as an adjunct to non-surgical treatment of chronic periodontitis
 
Preliminary Objectives : 1. To measure the clinical periodontal parameters (plaque index, gingival index, probing pocket depth, clinical attachment level ) in control group (sites treated with scaling and root planning alone) and study group (sites treated with scaling and root planing and 4% GM gel ) at baseline 2. To measure the clinical periodontal parameters (plaque index, gingival index, probing pocket depth, clinical attachment level ) in control group and study group at 4 weeks after treatment 3. To compare the clinical periodontal parameters (plaque index, gingival index, probing pocket depth, clinical attachment level) between baseline and 4 weeks after treatment in control group 4. To compare the clinical periodontal parameters (plaque index, gingival index, probing pocket depth, clinical attachment level) between baseline and 4 weeks after treatment in study group 5. To compare the clinical outcomes between control group and study group 4 weeks after treatment
 
Preliminary Sample Size : Minimum sample size of at least 30 sites in each group will be needed for the study (Total – 60 sites) (3 sites per patient – 20 patients)
 
Preliminary Study Duration : 1 year
 
Preliminary Study Area : Department of Periodontology, University of Dental Medicine, Mandalay
 
Preliminary Study Method : consecutive sampling method
 
Preliminary Research Outcome : GM gel can be considered as one of locally delivered agent which can be used in conjunction with scaling and root planing and adjunctive use of choice in periodontal treatment therapy
 
Preliminary Research Finding : ongoing
 
Preliminary Progress Report : ongoing
 
Study Starting Date : 2020-10-01
IRB/PRC/ERC Approval Date : 2020-08-26
 
Placement of IRB/PRC/ERC : university of dental medicine , mandalay
 
IRB/PRC/ERC Approval Letter/Document : 02122020132601128745919_4908611752512380_3619072020180869280_npdf.pdf
 
Pre-existing Registration ID : -
 
Pre-existing Name of Organization : -
 
Pre-existing Name of Organization Website : -