| CTRI Number |
CTRI/2021/08/035891 [Registered on: 24/08/2021] Trial Registered Prospectively |
| Last Modified On: |
19/08/2021 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized Factorial Trial |
|
Public Title of Study
|
To study the importance of oral hygiene and maintenance of oral hygiene in gum disease patients |
|
Scientific Title of Study
|
EVALUATION OF ALKALINE PHOSPHATASE LEVELS IN SALIVA AND SERUM OF CHRONIC PERIODONTITIS PATIENTS: A CLINICO-BIOCHEMICAL STUDY |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| Nil |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Preeti Singh |
| Designation |
Academic Junior Resident |
| Affiliation |
Institute of Medical Sciences |
| Address |
Unit of Periodontology, Faculty of Dental Sciences, BHU Trauma Centre, Banaras Hindu University, Lanka, Varanasi
Banaras Hindu University
Varanasi
UTTAR PRADESH
221005
India |
| Phone |
8528855513 |
| Fax |
|
| Email |
preetisingh2907@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Preeti Singh |
| Designation |
Academic Junior Resident |
| Affiliation |
Institute of Medical Sciences |
| Address |
Unit of Periodontology, Faculty of Dental Sciences, BHU Trauma Centre, Banaras Hindu University, Lanka, Varanasi
Banaras Hindu University
UTTAR PRADESH
221005
India |
| Phone |
8528855513 |
| Fax |
|
| Email |
preetisingh2907@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Preeti Singh |
| Designation |
Academic Junior Resident |
| Affiliation |
Institute of Medical Sciences |
| Address |
Unit of Periodontology, Faculty of Dental Sciences, BHU Trauma Centre, Banaras Hindu University, Lanka, Varanasi
Banaras Hindu University
UTTAR PRADESH
221005
India |
| Phone |
8528855513 |
| Fax |
|
| Email |
preetisingh2907@gmail.com |
|
|
Source of Monetary or Material Support
|
| Faculty of Dental Sciences, IMS BHU, Varanasi |
|
|
Primary Sponsor
|
| Name |
Preeti Singh |
| Address |
Unit of Periodontology, Faculty of Dental Sciences, Institute of Medical Sciences, Banaras Hindu University |
| Type of Sponsor |
Government medical college |
|
|
Details of Secondary Sponsor
|
|
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Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Sarita Parihar |
Faculty of Dental Sciences, IMS, BHU |
Room No 5, Floor No 3 Division of Periodontology
Varanasi
UTTAR PRADESH |
8004925677
drsarita6@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
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Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K053||Chronic periodontitis, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Patients who are devoid of any periodontal disease |
Salivary, Blood and GCF samples of subjects who are devoid of any periodontal disease are collected at interval at baseline for alkaline phosphatase levels for a period of 6 months |
| Intervention |
Patients who are found to have chronic periodontitis |
Salivary, Blood and GCF samples of subjects who are found to have chronic periodontitis are collected and evaluated for alkaline phosphatase levels at intervals of pre-op and one month following non-surgical therapy for a period of 6 months |
|
|
Inclusion Criteria
|
| Age From |
25.00 Year(s) |
| Age To |
55.00 Year(s) |
| Gender |
Both |
| Details |
Subjects with at least 25 years of age (25-55 years)
Subjects who have given written consent
Subjects who will be available for follow-up
• For Control Group: Participants with at least 20 natural teeth and probing pocket depth of 2-3 mm with no attachment loss and bleeding on probing with <20% sites.
For Study Group: Participants had to have 5 qualifying sites in 2 quadrants with a minimum of 2 affected teeth in each quadrant with each site having probing depth ≥ 5 mm, CAL ≥ 3 mm, bleeding on probing.
|
|
| ExclusionCriteria |
| Details |
Any history of metabolic or systemic disease
History of irradiation in the head or neck area
Smokers
Pregnant or lactating women
Has not undergone any periodontal therapy for past 1 year
Patients who are not maintaining their oral hygiene and patients lacking motivation during phase 1 therapy
|
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
Salivary ALP level
Serum ALP level
GCF ALP level
|
At baseline and 1 month after therapy
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Gingival Index (Loe & Silness)
Plaque Index (Silness & Loe)
Probing pocket depth (PPD)
Clinical Attachment Level (CAL)
are recorded for study |
At baseline and 1 month after therapy |
|
|
Target Sample Size
|
Total Sample Size="70"
Sample Size from India="70"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
Phase 1/ Phase 2 |
|
Date of First Enrollment (India)
|
30/08/2021 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
NIL |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Of the various illnesses that affect teeth, periodontitis is a common disease results in the destruction of supporting structures of the teeth, ultimately which cause tooth loss. Although periodontitis is an infectious disease of gingival tissue origin, changes that occur in the bone are crucial as the alveolar bone destruction is responsible for tooth loss. The most common cause of alveolar bone destruction in periodontitis is the extension of inflammation from the marginal gingiva to the underlying periodontal tissues. Salivary constituents for diagnosing periodontal disease include enzymes and immunoglobulins, hormones of host origin, bacteria and bacterial products, ions, and volatile compounds. Alkaline Phosphatase is a hydrolase enzyme responsible for removing phosphate groups from many types of molecules and is a marker of bone metabolism. It is a membrane‑bound glycoprotein produced by a various number of cells, such as polymorphonuclear leukocytes, macrophages, fibroblasts, and osteoblasts, within the area of the periodontium and gingival crevice. Various studies have assessed the levels of salivary ALP with respect to gingivitis, chronic periodontitis, and correlation of the same with clinical parameters. However, there was lagging evidence regarding the comparative effects of ALP in serum and saliva following periodontal treatment.
The purpose of this study is to compare the serum and salivary alkaline phosphatase levels before and after phase 1 periodontal therapy which serve to hold to the hypothesis that saliva can be used as an alternative to serum for evaluating alkaline phosphatase as a biomarker in periodontal disease progression. It will be one of the first study which focuses on the comparison between salivary and serum alkaline phosphatase levels before and after phase 1 periodontal therapy in healthy and chronic periodontitis patients. |