CTRI

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CTRI Number

CTRI/2025/09/095087 [Registered on: 19/09/2025] Trial Registered Prospectively

Last Modified On:

18/09/2025

Post Graduate Thesis

Yes

Type of Trial

Interventional

Type of Study

Dentistry

Study Design

Randomized, Parallel Group Trial

Public Title of Study

Study on using special barriers to prevent filling material from going beyond the root in children’s resorbing back teeth.

Scientific Title of Study

Assessment of the Efficacy of Apical Barrier Technique in Preventing the Extrusion of Obturating Material Using Resorbable Collagen Plug and Modified Suture Apical Matrix in Primary Mandibular Molar Undergoing Resorption-A Randomised Controlled Trial

Trial Acronym

NIL

Secondary IDs if Any

Secondary ID	Identifier
NIL	NIL

Details of Principal Investigator or overall Trial Coordinator (multi-center study)

Name	Risana Jasmin V P
Designation	Junior resident
Affiliation	Government Dental College ,Kozhikode
Address	Department of Pediatric and Preventive Dentistry, Room no.28,2nd Floor, Government Dental College ,Government Medical College, Kozhikode. Kozhikode KERALA 673008 India
Phone	9961210439
Fax
Email	risanajasmin96@gmail.com

Details of Contact Person
Scientific Query

Name	Dr Madhu S
Designation	Head of the department
Affiliation	Government Dental College ,Kozhikode
Address	Department of Pediatric and Preventive Dentistry, Room no.28,2nd Floor, Government Dental College ,Government Medical College, Kozhikode. Kozhikode KERALA 673008 India
Phone	9447775435
Fax
Email	madhupedo@gmail.com

Details of Contact Person
Public Query

Name	Risana Jasmin V P
Designation	Junior resident
Affiliation	Government Dental College ,Kozhikode
Address	Department of Pediatric and Preventive Dentistry, Room no.28,2nd Floor, Government Dental College ,Government Medical College, Kozhikode. Kozhikode KERALA 673008 India
Phone	9961210439
Fax
Email	risanajasmin96@gmail.com

Source of Monetary or Material Support

Government Dental College, Government Medical College, Kozhikode, 673008

Primary Sponsor

Name	Risana Jasmin V P
Address	Government Dental College,Government Medical College,Kozhikode,673008
Type of Sponsor	Other [Self]

Details of Secondary Sponsor

Name	Address
NIL	NIL

Countries of Recruitment

India

Sites of Study

No of Sites = 1
Name of Principal Investigator	Name of Site	Site Address	Phone/Fax/Email
Dr Risana Jasmin V P	Government Dental College,Kozhikode	Department of Pediatric and Preventive Dentistry, Room no.28,2nd Floor, Government Dental College ,Government Medical College, Kozhikode. Department of Pediatric and Preventive Dentistry, Room no.28,2nd Floor, Government Dental College ,Government Medical College, Kozhikode. Kozhikode KERALA	9961210439 risanajasmin96@gmail.com

Details of Ethics Committee

No of Ethics Committees= 1
Name of Committee	Approval Status
INSTITUITIONAL ETHICS COMMITTEE ,GOVERNMENT DENTAL COLLEGE ,KOZHIKODE	Approved

Regulatory Clearance Status from DCGI

Status

Not Applicable

Health Condition / Problems Studied

Health Type	Condition
Healthy Human Volunteers	Healthy patients requiring root canal therapy in primary mandibular molar teeth.
Patients	(1) ICD-10 Condition: K040\|\|Pulpitis,

Intervention / Comparator Agent

Type	Name	Details
Intervention	Group 1:Obturated with resorbable collagen plug as apical barrier. Group 2:Obturated with resorbable suture matrix as apical barrier.	Immediately after obturation 1.Apical extrusion of obturating material – assessed radiographically. 2.Radiographic success (baseline) – immediate postoperative radiograph. 3.Time taken for obturation – measured in minutes. At 3 months follow-up 4. Clinical success – evaluated based on absence of pain, swelling, sinus tract, tenderness, or abnormal mobility. At 6 months follow-up 5. Radiographic success – absence of periapical/furcal radiolucency, no pathological resorption, evidence of normal healing. 6. Clinical success – continued absence of symptoms and signs of pathology.
Comparator Agent	Group 3: Obturated with conventional technique without apical barrier	Immediately after obturation 1.Apical extrusion of obturating material – assessed radiographically. 2.Radiographic success (baseline) – immediate postoperative radiograph. 3.Time taken for obturation – measured in minutes. At 3 months follow-up 4. Clinical success – evaluated based on absence of pain, swelling, sinus tract, tenderness, or abnormal mobility. At 6 months follow-up 5. Radiographic success – absence of periapical/furcal radiolucency, no pathological resorption, evidence of normal healing. 6. Clinical success – continued absence of symptoms and signs of pathology.

Inclusion Criteria

Age From	7.00 Year(s)
Age To	10.00 Year(s)
Gender	Both
Details	1.7-10 year old children whose mandibular primary molar with irreversible pulpitis indicated for pulpectomy. 2.Primary mandibular molars with at least two-thirds of the root length reamaining. 3.Patients exhibiting Frankels positive or definitely positive behavior.

ExclusionCriteria

Details

1.Non-restorable teeth.
2.Radiographic evidence of severe external or internal pathological resorption.
3.Peri-radicular radiolucencies involving the permanent tooth follicle.
4.Primary mandibular molars with preoperative radiographs showing extreme positioning (mesial/distal) of the permanent tooth bud.
5.Teeth with no radiographic resorption.
6.Dentition with congenitally missing permanent tooth buds.
7.Uncooperative during treatment after initially being cooperative.
8.Tooth with perforation of the pulpal floor.
9.Extreme tooth mobility.
10.Presence of dentigerous or follicular cyst.
11.Differently abled children and childrens with systemic disease.

Method of Generating Random Sequence

Permuted block randomization, fixed

Method of Concealment

Sequentially numbered, sealed, opaque envelopes

Blinding/Masking

Participant and Outcome Assessor Blinded

Primary Outcome

Outcome	TimePoints
1.APICAL EXTRUSION:Efficacy of different apical barriers in preventing apical extrusion of obturating materials in deciduous tooth pulpectomies	1.Apical extrusion assessed using radiograph immediately after obturation.

Secondary Outcome

Outcome	TimePoints
1.Radiographic Success 2.Clinical Success 3.Time taken for obturation in minute.	1.Radiographic success immediately & 6 months after obturation 2.Clinical success at 3 month & 6 month after obturation 3.Time taken for obturation in minute.

Target Sample Size

Total Sample Size="225"
Sample Size from India="225"
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 2/ Phase 3

Date of First Enrollment (India)

30/09/2025

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="6"
Days="0"

Recruitment Status of Trial (Global)

Not Applicable

Recruitment Status of Trial (India)

Not Yet Recruiting

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

Assessment of the efficacy of apical barrier technique in preventing the extrusion of obturating material using resorbable collagen plug and modified suture apical matrix in primary mandibular molar undergoing resorption- A randomized controlled trial.

Pulp therapy in primary teeth, particularly in resorbing mandibular molars, is often complicated by apical extrusion of obturating material due to open apices and physiological root resorption. Extrusion may result in postoperative complications such as inflammation, pain, or damage to the underlying permanent tooth bud.

Effective apical barriers are needed to prevent this while maintaining biocompatibility and resorbability suitable for primary dentition.This study assess the efficacy of different resorbable apical barriers in preventing apical extrusion of obturation materials in deciduous tooth pulpectomies.

The groups are Group A: Resorbable collagen plug as apical barrier. Group B: Modified suture apical matrix as apical barrier. Group C (Control): Conventional obturation without apical barrier.

Sample size of the study is 225 root canals and the study period is 1.5 years.

Primary objective is to compare the radiographic assessment of apical extrusion of obturating material using three different techniques.

Secondary objective is to compare the radiographic success of obturation using these three techniques immediately and 6 month interval. To assess the clinical success of obturation using these three techniques 3month and 6 month interval. To compare the time taken for obturation using these three technique.

The null hypothesis state that there is no significant difference in the apical extrusion of obturating material in resorbing primary mandibular molars with apical barrier technique using resorbable collagen plug or modified suture apical matrix and the conventional method of obturation without the use of an apical barrier.

The following clinical outcomes are assessed-

Presence of apical extrusion of obturation material , Quality of obturation (radiographic), radiographic success immediately and 6 months after obturation, Clinical success of obturation in 3 and 6 months and finally Time taken for obturation using stopwatch.