| CTRI Number |
CTRI/2022/06/043007 [Registered on: 03/06/2022] Trial Registered Prospectively |
| Last Modified On: |
03/04/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Dentistry |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A Randomized clinical study to check the inter-appointment pain in patients with infected teeth using two different combination of drugs |
|
Scientific Title of Study
|
Comparative evaluation of two different intracanal medicament regimes for inter-appointment pain management in infected single rooted teeth with Symptomatic Apical Periodontitis- A Randomized double-blinded Clinical Study. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Dikshit Solanki |
| Designation |
Post Graduate student |
| Affiliation |
Km shah dental college and hospital |
| Address |
No.8, Department of conservative dentistry and endodontics, km shah dental college and hospital, sumandeep vidhyaoeeth, pipariya, vadodara- 391760.
Vadodara
GUJARAT
391760
India |
| Phone |
7977557010 |
| Fax |
|
| Email |
dmsolanki170997@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Ajay singh rao |
| Designation |
Reader |
| Affiliation |
km shah dental college |
| Address |
No.8, Department of conservative dentistry and endodontics, km shah dental college and hospital, sumandeep vidhyaoeeth, pipariya, vadodara- 391760.
Vadodara
GUJARAT
391760
India |
| Phone |
8385017307 |
| Fax |
|
| Email |
drajayinendo@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Ajay singh rao |
| Designation |
Reader |
| Affiliation |
km shah dental college |
| Address |
No.8, Department of conservative dentistry and endodontics, km shah dental college and hospital, sumandeep vidhyaoeeth, pipariya, vadodara- 391760.
Vadodara
GUJARAT
391760
India |
| Phone |
8385017307 |
| Fax |
|
| Email |
drajayinendo@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Dr DIKSHIT SOLANKI |
| Address |
No. 8, Department of conservative dentistry and endodontics, km Shah dental college and hospital, sumandeep vidhyapeeth, pipariya, vadodara-391760 |
| Type of Sponsor |
Other [self] |
|
|
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 |
| Dr Dikshit Solanki |
Km shah dental college |
NO.8, Department of conservative dentistry and endodontics, km shah dental college and hospital,sumandeep vidhyapeeth,pipariya, vadodara 391760
Vadodara
GUJARAT |
7977557010
dmsolanki170997@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Sumandeep Vidyapeeth institutional ethics committee (SVIEC) |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
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|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K044||Acute apical periodontitis of pulpal origin, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
DOUBLE ANTIBIOTIC PASTE |
IT IS MADE OF METRONIDAZOLE-500 mg AND CIPROFLOXACIN-500mg.Application for once after 1st visit as a intra canal medicament for 6 days |
| Intervention |
MODIFIED DOUBLE ANTIBIOTIC PASTE |
IT CONSISTS OF METRONIDAZOLE-5oomg,CIPROFLOXACIN-500mg AND VALACYCLOVIR-500mg. Application for once after 1st visit as a intra canal medicament for 6 days |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Systemically healthy patients between age group of 18-60 years with maxillary or mandibular single rooted infected/necrotic teeth with symptomatic apical periodontitis will be included in the study.
Symptomatic chronic irreversible pulpitis with symptomatic apical periodontitis with loss of lamina dura will be included.
Symptomatic teeth showing presence of peri-apical radiolucency suggestive of periapical abscess will be included.
patients with pre-operative moderate to severe pain will be included.
A written informed consent will be taken and only those patients ready to sign the consent will be included in the study. |
|
| ExclusionCriteria |
| Details |
Asymptomatic teeth with periapical radiolucencies be it abscess or granuloma, etc will be excluded.
Medically compromised patients will be excluded.
Teeth with completely obliterated canals will be excluded.
Teeth with open apex, root resorption or complex root canal anatomy will be excluded.
Teeth with vertical root canal fractures, cracks, etc will be excluded.
Patients with deep periodontal disease or endo-perio lesion with periodontal phase dominant will be excluded.
Pregnant and lactating women will be excluded.
Patients using other medications such as analgesics or anti-inflammatory drugs during inter appointment will be excluded.
Patients allergic to antibiotics and anti-viral drugs will be excluded.
|
|
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Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Interappointment pain assessment |
6hr,12 hr,24hr,3 days,6days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| efficacy of modified double antibiotic paste in pain management |
6hr,12 hr,24hr,3 days,6days |
|
|
Target Sample Size
|
Total Sample Size="72"
Sample Size from India="72"
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="72" |
|
Phase of Trial
|
Phase 1/ Phase 2 |
|
Date of First Enrollment (India)
|
06/06/2022 |
| Date of Study Completion (India) |
22/03/2024 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
22/03/2024 |
|
Estimated Duration of Trial
|
Years="2"
Months="6"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Completed |
| 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)?
Response - NO
|
|
Brief Summary
|
This study is a randomized, double blinded, parallel group clinical study comparing reduction of the inter-appointment pain between double antibiotic paste and modified double antibiotic paste containing valacyclovir for 12 months on 72 patients at department of conservative dentistry and endodontics, km shah dental college and hospital. The primary outcome measure will be inter-appointment pain reduction at 6hrs,12hrs, 24hrs,48hrs,3days and 6days. |