| CTRI Number |
CTRI/2016/03/006760 [Registered on: 22/03/2016] Trial Registered Retrospectively |
| Last Modified On: |
22/03/2016 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Dentistry |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
A clinical study to evaluate the effect of Trehalose gel in the tretment of gum diseases |
|
Scientific Title of Study
|
Evaluation of the efficacy of local application of Trehalose gel as an adjunct to scaling and root planing in the management of chronic periodontitis |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dhishann Babu Paturu |
| Designation |
Postgraduate |
| Affiliation |
Narayana Dental College and Hospital |
| Address |
Department of Periodontics,
Narayana Dental College and Hospital
Nellore
Andhrapradesh
Nellore
ANDHRA PRADESH
524003
India |
| Phone |
9492906374 |
| Fax |
|
| Email |
drdhishannpaturu@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
SREENIVAS NAGARAKANTI |
| Designation |
Professor |
| Affiliation |
NARAYANA DENTAL COLLEGE AND HOSPITAL |
| Address |
DEPARTMENT OF PERIODONTICS, NARAYANA DENTAL COLLEGE AND HOSPITAL, CHINTHAREDDYPALEM, NELLORE
Nellore
ANDHRA PRADESH
524003
India |
| Phone |
9985664566 |
| Fax |
|
| Email |
sreenivasnagarakanti@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
SREENIVAS NAGARAKANTI |
| Designation |
Professor |
| Affiliation |
NARAYANA DENTAL COLLEGE AND HOSPITAL |
| Address |
DEPARTMENT OF PERIODONTICS, NARAYANA DENTAL COLLEGE AND HOSPITAL, CHINTHARDDYPALEM, NELLORE
Nellore
ANDHRA PRADESH
524003
India |
| Phone |
9985664566 |
| Fax |
|
| Email |
sreenivasnagarakanti@gmail.com |
|
|
Source of Monetary or Material Support
|
| Self Funded (Principal Investigator) |
|
|
Primary Sponsor
|
| Name |
NIL |
| Address |
NIL |
| Type of Sponsor |
Other [NIL] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dhishann Babu Paturu |
NARAYANA DENTAL COLLEGE AND HOSPITAL |
Room number 9,
Department of Periodontics
Nellore
ANDHRA PRADESH |
9492906374
drdhishannpaturu@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committee, Narayana Dental College and Hospital |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
systemically healthy |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Gelatin gel (Placebo) |
One time application |
| Intervention |
Trehalose |
90 mg / ml
one time application |
|
|
Inclusion Criteria
|
| Age From |
30.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
Patients diagnosed to have chronic periodontitis with probing depths of ≥ 5mm on two bilateral or contra lateral sites.
Systemically healthy |
|
| ExclusionCriteria |
| Details |
Patients having systemic diseases
Patients who have received any topical or systemic antimicrobial treatment in the past 6 months including the use of mouthwash.
Patients who have had periodontal treatment in the last 6 months.
Pregnant and lactating mothers.
Smokers.
|
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Double Blind Double Dummy |
|
Primary Outcome
|
| Outcome |
TimePoints |
| decrease in clinical inflammation and probing depth |
baseline and 3 months |
|
|
Secondary Outcome
|
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
Final Enrollment numbers achieved (Total)= ""
Final Enrollment numbers achieved (India)="" |
|
Phase of Trial
|
Phase 1/ Phase 2 |
|
Date of First Enrollment (India)
|
07/01/2015 |
| Date of Study Completion (India) |
Date Missing |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
NIL |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
Background & objectives: Trehalose is a non reducing disaccharide in which two glucose molecules are linked together by a 1, 1-glucosidic linkage. It has been shown that trehalose has suppressive effect on pathological bone resorption and it also inhibits proinflammatory cytokine production induced by a major periodontal pathogen Porphyromonas gingivalis. Hence, in the present study an attempt was made to study clinical effects of trehalose gel in chronic periodontitis subjects. Materials and methods: Thirty patients with two sites in the bilateral quadrants having probing pocket depths of ≥ 5mm were selected. Scaling and root planing was performed followed by assessment of gingival index, probing pocket depth, and relative clinical attachment level at baseline and 3 months. Test site received trehalose gel and control site received placebo gel. All the values were subjected for statistical analysis. Results: Comparison of gingival index, plaque index, pocket probing depth clinically at baseline and 3 months for test and control sites showed significance improvement but there was no significant difference between two sites (i.e. test site & control site) with this regard.
Conclusion: Trehalose gel does not have considerable advantage over SRP alone as an adjunct to scaling and root planing, in the treatment of chronic periodontitis. |