| CTRI Number |
CTRI/2025/02/080734 [Registered on: 18/02/2025] Trial Registered Prospectively |
| Last Modified On: |
06/02/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
A six month comparative evaluation of the healing of dental periapical lesions among various ABO blood group individuals A CBCT based observational study |
|
Scientific Title of Study
|
A six month comparative evaluation of the healing of periapical lesions among various ABO blood group individuals A CBCT based observational study |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Riddhi Vasa |
| Designation |
PG Student |
| Affiliation |
K.M. SHAH DENTAL COLLEGE AND HOSPITAL |
| Address |
8, Department of Conservative Dentistry and Endodontics, K.M. SHAH Dental College and Hospital Sumandeep Vidyapeeth Waghodia, Vadodara 391760
Vadodara
GUJARAT
391760
India |
| Phone |
8583097772 |
| Fax |
|
| Email |
vasariddhi1@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Ajay Singh Rao |
| Designation |
PG Guide |
| Affiliation |
K.M. SHAH DENTAL COLLEGE AND HOSPITAL |
| Address |
8, Department of Conservative Dentistry and Endodontics, K.M. SHAH Dental College and Hospital Sumandeep Vidyapeeth Waghodia, Vadodara 391760
Vadodara
GUJARAT
391760
India |
| Phone |
08385017307 |
| Fax |
|
| Email |
drajayinendo@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Riddhi Vasa |
| Designation |
PG Student |
| Affiliation |
K.M. SHAH DENTAL COLLEGE AND HOSPITAL |
| Address |
8, Department of Conservative Dentistry and Endodontics, K.M. SHAH Dental College and Hospital Sumandeep Vidyapeeth Waghodia, Vadodara 391760
Vadodara
GUJARAT
391760
India |
| Phone |
8583097772 |
| Fax |
|
| Email |
vasariddhi1@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Dr Riddhi Vasa |
| Address |
8, Department of Conservative Dentistry and Endodontics, K.M. SHAH Dental College and Hospital Sumandeep Vidyapeeth Waghodia, 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 RIDDHI VASA |
K.M SHAH DENTAL COLLEGE AND HOSPITAL |
8,Department of Conservative Dentistry and Endodontics, K.M. SHAH Dental College and Hospital Sumandeep Vidyapeeth Waghodia, Vadodara 391760
Vadodara
GUJARAT |
08583097772
vasariddhi1@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| SUMANDEEP VIDYAPEETH INSTITUTIONAL ETHICS COMMITTEE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: Z789||Other specified health status, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
INDIVIDUALS WITH A POSITIVE B POSITIVE AND AB POSITIVE BLOOD GROUPS |
A, B, AND AB BLOOD GROUPS AMONG ABP BLOOD GROUPS AND RH POSITIVE TYPE will be compared with O +VE individuals for 6 months. |
| Intervention |
INDIVIDUALS WITH O POSITIVE BLOOD GROUPS |
BLOOD GROUP O AMONG ABO BLOOD GROUPS AND RH POSITIVE TYPE are categorised under intervention as angelus bio-c sealer will be used for obturation and will followed uo for 6 months. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Day(s) |
| Age To |
45.00 Year(s) |
| Gender |
Both |
| Details |
1.Systemically healthy patients (Category: American Society of Anesthesiologists class 2 or less than 2) less than 45 years of age with maxillary or mandibular teeth diagnosed with symptomatic or asymptomatic apical periodontitis or acute exacerbation of chronic abscess will be included in the study.
2.Maxillary or mandibular single rooted teeth diagnosed with Pulpal necrosis with symptomatic or asymptomatic apical periodontitis with lesions that show periapical radiolucency with (CBCTPAI) Score 3 will be included in the study.
3.Re-treatment with periapical lesions with CBCTPAI Score 3 will be included in the study.
4.Patients who are aware of their respective blood groups will only be included in the study.
5.A written informed consent will be taken from all the patients and only those patients ready to sign the consent form will be included in the study.
|
|
| ExclusionCriteria |
| Details |
1.Pregnant and lactating women will be excluded.
2.Patients having uncontrolled diabetes, uncontrolled hypertension and immunocompromised will be excluded from the study.
3.Patients with history to any drug allergy will be excluded from the study.
4. Patients having teeth with poor prognosis, open apices, internal/external resorption, fractured roots or visibly cracked tooth, grade 3 mobility, severe periodontal bone loss will be excluded from the study.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| O POSITIVE INDIVIDUALS WILL SHOW BETTER PERIAPICAL HEALING AS COMPARED TO OTHER GROUPS DUE TO PRESENCE OF ANTI A- AND ANTI-B ANTIBODIES |
O POSITIVE INDIVIDUALS WILL SHOW BETTER PERIAPICAL HEALING AS COMPARED TO OTHER GROUPS DUE TO PRESENCE OF ANTI A- AND ANTI-B ANTIBODIES AS SEEN ON CBCT AT BASELINE(after 24 hrs AND after6 MONTHS) |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| O POSITIVE INDIVIDUALS WILL SHOW BETTER PERIAPICAL HEALING AS COMPARED TO OTHER GROUPS DUE TO PRESENCE OF ANTI A- AND ANTI-B ANTIBODIES |
O POSITIVE INDIVIDUALS WILL SHOW BETTER PERIAPICAL HEALING AS COMPARED TO OTHER GROUPS DUE TO PRESENCE OF ANTI A- AND ANTI-B ANTIBODIES after 6 months |
|
|
Target Sample Size
|
Total Sample Size="48"
Sample Size from India="48"
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 3 |
|
Date of First Enrollment (India)
|
01/03/2025 |
| 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)
Modification(s)
|
Open to Recruitment |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
THE STUDY AIMS TO COMPARE PERIAPICAL HEALING USING ANGELUS BIOCERAMIC SEALER IN ROOT CANAL OB6TURATED TEETH USING HYDRAULIC CONDENSATION TECHNIQUE AMONG 4 DIFFERENT BLOOD GROUPS - A , B AB AND O POSITIVE AS SEEN ON CBCT AT BASELINE AND AT 6 MONTHS. IT IS A 6-MONTH FOLLOW-UP STUDY. |