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CTRI Number  CTRI/2025/01/079057 [Registered on: 20/01/2025] Trial Registered Prospectively
Last Modified On: 19/01/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Dentistry 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   To compare orthograde versus retrograde root canal filling technique during endodontic microsurgery in anterior teeth 
Scientific Title of Study   Comparison of Two Root End Filling Techniques during Endodontic Microsurgery of Permanent Anterior Teeth: A Parallel Double Blind Randomized Clinical Trial 
Trial Acronym  Endodontic Microsurgery 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Fiyaz Ghan A S 
Designation  Junior Resident 
Affiliation  Centre for Dental Education and Research, All India Institute of Medical Sciences, New Delhi 
Address  Division of Conservative Dentistry and Endodontics, Centre for Dental Education and Research, All India Institute of Medical Sciences, New Delhi

South
DELHI
110016
India 
Phone  7001640156  
Fax    
Email  asfiyazghan@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Sidhartha Sharma 
Designation  Associate Professor 
Affiliation  Centre for Dental Education and Research, All India Institute of Medical Sciences, New Delhi 
Address  Division of Conservative Dentistry and Endodontics, Centre for Dental Education and Research, All India Institute of Medical Sciences, New Delhi

South
DELHI
110016
India 
Phone  9582542655  
Fax    
Email  sid.aiims@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Sidhartha Sharma 
Designation  Associate Professor 
Affiliation  Centre for Dental Education and Research, All India Institute of Medical Sciences, New Delhi 
Address  Division of Conservative Dentistry and Endodontics, Centre for Dental Education and Research, All India Institute of Medical Sciences, New Delhi

South
DELHI
110016
India 
Phone  9582542655  
Fax    
Email  sid.aiims@gmail.com  
 
Source of Monetary or Material Support  
Centre for Dental Education and Research, All India Institute of Medical Sciences, New Delhi 
 
Primary Sponsor  
Name  Dr Fiyaz Ghan A S 
Address  Junior Resident, Division of Conservative Dentistry and Endodontics, Centre of Dental Education and Research , All India Institute of Dental Sciences and Research, New Delhi 
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 Fiyaz Ghan A S  Centre for Dental Education and Research, All India Institute of Medical Sciences, New Delhi   Division of Conservative Dentistry and Endodontics, Centre for Dental Education and Research, All India Institute of Medical Sciences, New Delhi 110016
South
DELHI 
7001640156

asfiyazghan@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
AIIMS Institutional Ethics Committee   Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: K045||Chronic apical periodontitis, (2) ICD-10 Condition: K041||Necrosis of pulp, (3) ICD-10 Condition: K046||Periapical abscess with sinus, (4) ICD-10 Condition: K047||Periapical abscess without sinus,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Orthograde MTA Appproach   Two visit Nonsurgical Root canal therapy will be performed with calcium silicate based cements placed at the root apex in second visit followed by backfilling with gutta percha. A endodontic microsurgery will be performed after 7 days to remove the 3 mm infected root apex of the involved tooth. 
Comparator Agent  Retrograde MTA Approach  Two visit Nonsurgical Root canal therapy will be performed with gutta percha placed at the root apex at second visit. A endodontic microsurgery will be performed after 7 days to remove the 3 mm infected root apex and retrofilled with calcium silicate based cement of the involved tooth. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  1.Patients aged 18–60 years
2.Non-vital anterior teeth with single canal
3.Patients with Symptomatic Apical
Periodontitis and Persistent apical periodontitis
after NSET scheduled for periapical surgery
with large (greater than 5mm) periapical lesion
4.Adequate access to apical third of the root 
 
ExclusionCriteria 
Details  1.Patients with systemic conditions affecting
healing (e.g., diabetes)
2.Teeth with vertical root fractures
3.Apico-marginal defect
4.Patients with inadequate oral hygiene or
periodontal health
5.Pregnant or lactating women 
 
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 
1. To evaluate the clinical and radiographic
outcome of orthograde placement of root-end
filling material followed by root end resection
during endodontic microsurgery in permanent
anterior teeth.
2. To evaluate the clinical and radiographic
outcome of conventional retrograde placement
of root-end filling material following root end
resection and preparation during endodontic
microsurgery in permanent anterior teeth.
3. To compare the above 
6 months and 1 year 
 
Secondary Outcome  
Outcome  TimePoints 
To evaluate the postoperative pain, swelling,
analgesics needed, and patient reported quality
of life (OHRQoL) for orthograde placement of
root-end filling material followed by root end
resection during endodontic microsurgery in
permanent anterior teeth.
2. To evaluate the postoperative pain, swelling,
analgesics needed, and patient reported quality
of life (OHRQoL) for conventional retrograde
placement of root-end filling material
following root end resection and preparation
during endodontic microsurgery in permanent
anterior teeth.
3. To compare the above 
1 week 
 
Target Sample Size   Total Sample Size="56"
Sample Size from India="56" 
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="56" 
Phase of Trial   Phase 3 
Date of First Enrollment (India)   30/01/2025 
Date of Study Completion (India) 31/12/2025 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="1"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Completed 
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  
Periapical lesions are a common outcome of pulpal infections often leading to the
need for endodontic intervention. While conventional root canal therapy (RCT)
serves as the primary mode of treatment for infected or necrotic pulps, there are
cases where it does not yield the desired therapeutic outcome. When nonsurgical
retreatment fails or is unlikely to succeed, surgical intervention becomes necessary,
making endodontic microsurgery (EMS) a crucial treatment option. This
microsurgical technique, enhanced by magnification tools such as surgical
microscopes and loupes, allows precise surgical intervention to address unresolved
periapical infections. EMS results in high long-term healed (78.3%) and survival
(95.2%) rates
The most critical step of EMS is Root End Filling which comprises of root end
resection, root end preparation and root end filling. Root end resection involves
removal of 3 mm of the root apex, followed by retrograde preparation of canal by
ultrasonic tips and retro-filling it with a biocompatible material. However, it is
more technique-sensitive, as it involves working within a small surgical field under
magnification. Furthermore, there is a risk of the filling material being washed out
before it sets properly due to a lack of effective hemostasis around the root-end
area. Retrograde placement necessitates specialized armamentarium and
preparation of the root-end before placing the filling material carries a risk of
initiating or propagating microcracks, which may eventually result in vertical root
fractures.
There is a concept of ―orthograde technique,‖ which has been proposed. In this,
after completion of biomechanical preparation and achieving a dry canal , the root end
filling material like MTA/Bio dentine is introduced into the root canal space
to about 7 mm from the root apex, followed by obturation of the root canal. The
surgery is performed after 3-5 days. Surgery involves resecting the root end
eliminating the need of retro preparation and retro-filling. This can potentially
reduce postoperative discomfort, including pain and swelling. Wash out of the set.
material is prevented from blood contamination and there is no need of specialized
armamentarium such as ultrasonics reducing the risk of dentinal microcracks.
The efficacy of orthograde technique has been evaluated in few in vitro and animal
studies. Andelin et al (2002) conducted a dye leakage study on 46 extracted teeth
to evaluate the effect of resection on the microleakage of MTA. They found no
significant difference in leakage in teeth with resected MTA or in those with MTA
placed as a retrograde root-end filling material. A micro-CT study (2022) found
no significant difference among the two techniques regarding the total volume of
voids in the root canal of extracted single rooted teeth. Another in vitro study
(2023) found that the retrograde method offered superior marginal adaptation,
while the orthograde method demonstrated greater resistance to dislodgement. An
animal study by Apaydin et al (2003) compared the effects of fresh and set
mineral trioxide aggregate (MTA) on hard tissue healing after peri radicular
surgery. Root canals of 24 mandibular premolars in four 2-year-old beagle dogs
were filled with MTA. After two weeks, half of the roots were resected to the set
MTA, while the other half were prepared ultrasonically and filled with fresh MTA.
Four months later, histomorphometry analysis revealed that fresh MTA led to
significantly higher cementum formation (12/12 vs. 8/12, p = 0.028), but there was
no notable difference in the amount of cementum or bone healing between the two
groups. Another animal study (2011) reported no significant difference in
inflammation or hard tissue healing between the two techniques, though fresh
MTA showed slightly better outcomes.
Despite the presence of favorable in vitro and animal studies, there is no clinical
evidence directly comparing their outcomes of these two techniques. Thus,
conducting a comparative clinical study is essential to assess which method offers
better clinical success and patient outcomes. Hence the proposed randomized
clinical trial aims to compare the outcomes of orthograde and retrograde
placement of root-end filling materials during endondontic microsurgery in
permanent anterior teeth.
 
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