Periapical DiseasesNCT06643676
Effect of Targeted Endodontic Microsurgery on Quality of Life and Healing on Mandibular Molars
A study testing Targeted Endodontic Microsurgery Using 3d Printed surgical guide using the patient's CBCT data and Conventional Endodontic Microsurgery with a free hand procedure using bur and CBCT analysis in people with Periapical Diseases and Periapical Periodontitis, run by Postgraduate Institute of Dental Sciences Rohtak at 1 site in India.
Trial summary
Targeted endodontic microsurgery represents precise and advanced approach to resolving persisting chronic periapical periodontitis after non- surgical root canal treatment. This specialised procedure involves accessing the root tip of the tooth under high magnification using dental operating microscopes and employing… Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Periapical Diseases, Periapical Periodontitis, Periapical Cyst
- What is being tested?
- Targeted Endodontic Microsurgery Using 3d Printed surgical guide using the patient's CBCT data and Conventional Endodontic Microsurgery with a free hand procedure using bur and CBCT analysis
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 62 participants
- Where
- 1 siteIndia
- Study dates
- 1 Jul 2024to 31 Dec 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Patients with persistent symptomatic Or asymptomatic apical periodontitis and periapical radiolucency.
- Previous history of Root canal retreatment.
- Tooth with a peri-radicular lesion of strictly endodontic origin KIM's Classification A,B,C)
- Patients between 18-55 years of age.
- No general medical contraindications for oral surgical procedures (ASA-1) according to the classification of the American Society of Anesthesiologists)
- ASA 1- A normal healthy patient. Example: Fit, nonobese (BMI under 30), nonsmoking, patient with good exercise tolerance.
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- Tooth with adequate final restoration without clinical evidence of coronal leakage.
- No spontaneous pain or swelling.
- Good periodontal health condition at tooth level
- Able to completely understand and sign an informed consent form
Who cannot join
- Patients with systemic diseases (diabetes mellitus, uncontrolled hypertension grade III, hepatic/renal disease, or systemic bleeding disorders)
- Patients on anticoagulant/ antiplatelet drugs.
- Fractured/perforated teeth.
- Teeth with deep pockets (probing depth > 4 mm).
- Presence of vertical root fracture.
- Miller class III/IV mobility.
- Pregnancy.
- second mandibular molars
Trial locations and contacts
1 site in 1 country.
India1 site
Post Graduate Institute of Dental Sciences , Rohtak
Rohtak, Haryana, 124001
About this study
Official title: Effect of Targeted Endodontic Microsurgery on Quality of Life and Healing on Mandibular Molars : A Randomized Controlled Trial
Targeted endodontic microsurgery represents precise and advanced approach to resolving persisting chronic periapical periodontitis after non- surgical root canal treatment. This specialised procedure involves accessing the root tip of the tooth under high magnification using dental operating microscopes and employing microsurgical instruments to remove infected or inflamed tissue, as well as any pathological lesions present in the periapical region. Targeted Endodontic Microsurgery is useful for osteotomy and root- end resection when exacting control of depth, diameter, and angulation of osteotomy and root end resection is necessary. Using a CBCT(cone beam computed tomography) designed 3D - printed surgical guideis a more accurate method for access to the apical portion of the root during surgical endodontics compared with a "freehand" CBCT - approximated conventional method. These guided have the potential to increase accuracy and precision and to reduce intraoperative time as well as postoperative complications. Additionally, it provides a viable treatment option for patients who may not be candidates for traditional root canal therapy or retreatment due to anatomical complexities or previous treatment failures.
Read the detailed description
Conventional Endodontic microsurgery takes use of a preoperative scan and manual drilling of the osteotomy site with arbitrary measurements followed by retropreparation and forming the apical seal. One of the most critical disadvantages of conventional root-end resection include the damage to anatomically vital structures such as inferior dental nerve, mental nerve, adjacent root and maxillary sinus. In contrast, endodontic microsurgery using the guide template significantly reduces these damages. Pinsky et al confirmed in their in vitro study that the greater accuracyand consistency was achieved during endodontic surgery with surgical guidance without damaging vital structures. An error greater than 3 mm occurred over 22% of the time with freehand whereas none of errors occurred with surgical guidance.
Consequently, targeted endodontic microsurgery has garnered increasing attention as a viable alternative, offering a refined and precise approach to address such challenges.
Even the most skilled surgeons may find endodontic microsurgery difficult. Some medical professionals steer clear using freehand (FH) Endodontic microsurgery in regions where there is a chance of harming important anatomical features including the maxillary sinus, the mental foramen, and arteries. It is Perceived as complex sites include those with limited access, no direct sight, and areas where the apex is placed distant from the buccal cortical bone without any cortical plate fenestratio. Surgeons may be able to perform precise procedures in difficult-to-reach regions with guided Endodontic Microsurgery
Guided Endodontic Microsurgery is virtually planned on 3D software on the preoperative CBCT scan, and the surgeon executes the osteotomy and root-end resection (RER) under static or dynamic navigation.
Static navigation requires a customized 3D-printed surgical guide (3D-SG) to guide the drilling duringosteotomy and RER. Surgical guides contain a guide template that refers to the 3D location of the virtual Endodontic Microsurgery planned in the CBCT to drill accurately Prior research has demonstrated that 3D-SG can reduce the risk of intra-operative complications whileincreasing the precision and effectiveness of EMS. In comparison to free hand Endodontic Microsurgery, guided Endodontic Microsurgery with 3D-Surgical Guide shortens the surgical time, provides superior control over the resection level and bevel off the root, and enables a tailored osteotomy size.
Trephine burs have been used for the removal of failed implants and autogenous bone graft harvesting but have not previously been described in Endodontic Microsurgery .
Targeted Endodontic Microsurgery produces a single-step osteotomy; root-end resection; and biopsy with a defined perforation site, angulation, depth, and diameter. Previous reports have used 3D Surgical Guides to locate an ideal bone perforation site, but none have used trephine burs within a stent to define all parameters of osteotomy and root-end resection.
Also, no clinical study assessing the targeted approach of endodontic microsurgery with Oral health related quality of life has been done. Some of the RCT's are conducted assessing quality of life in patients after conventional periapical surgery, only two retrospective studies considering .Targeted Endodontic Microsurgery have been done and a lack of RCTs comparing targeted Endodontic Microsurgery with conventionalEMS warrants further research.
The aim of this study is to compare the effect of a static computer-aided surgical technique using a 3D- printed guide with a fully guided drill protocol on Oral Health Related Quality of Life against the conventional endodontic microsurgery in mandibular molars.
- Conditions
- Periapical Diseases, Periapical Periodontitis, Periapical Cyst, Periapical Granuloma, Periapical Pathology, Endodontic Microsurgery
- Being tested
- Targeted Endodontic Microsurgery Using 3d Printed surgical guide using the patient's CBCT data, Conventional Endodontic Microsurgery with a free hand procedure using bur and CBCT analysis
- Medical subject headings
- Periapical Diseases, Periapical Periodontitis, Radicular Cyst, Periapical Granuloma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Targeted Endodontic Microsurgery Using 3d Printed surgical guide using the patient's CBCT dataProcedure or surgery
Also called periapical surgery, Targeted Endodontic Microsurgery, Guided Endodontic Microsurgery, apicoectomy
Patients with apical periodontitis with intact cortex in madibular molars receiving Targeted Endodontic surgery or Guided Endodontic Microsurgery with surgical guide fabricated using the cbct data following failure of non surgical root canal treatment
Conventional Endodontic Microsurgery with a free hand procedure using bur and CBCT analysisProcedure or surgery
A conventional endodontic microsurgery using arbitrary localisation technique using the cbct data and performing the surgery with a carbide bur.
| Study group | Role | What they receive |
|---|---|---|
| Targeted Endodontic Microsurgery using trephine drill and 3d printed surgical guide | Experimental | Endodontic Microsurgery using 3d printed static surgical guide using patient's cbct data Receives: Procedure: Targeted Endodontic Microsurgery Using 3d Printed surgical guide using the patient's CBCT data |
| Conventional Endodontic microsurgery using burs | Active comparator | Conventional Endodontic microsurgery using carbide bur and free hand conventional procedure Receives: Procedure: Conventional Endodontic Microsurgery with a free hand procedure using bur and CBCT analysis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Quality of life following periapical surgery
Quality of life quantified using Questionnaire to both groups
Measured: 1 year
Secondary outcomes (3)
Radiographic healing
two dimensional radiographic healing by rud and molten criteria three dimensional radiographic healing with Cbct by modified Penn criteria
Measured: 1 year
Time Taken for surgery(Till osteotomy and root end resection)
Time taken to complete surgery in both the groups
Measured: one year
Accuracy of surgical access
Osteotomy size was assessed intraoperatively in both the TEMS and CEMS groupsimmediately after completion of the osteotomy and root-end resection. The maximum mesiodistal width and apicocoronal height of the osteotomy were measured at the level of the buccal cortical plate using a periodonal probe, which served as the standardized anatomical reference for both surgical techniques.
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Oct 2024
- Study start1 Jul 2024
- Primary completion15 Dec 2025
- Study completion31 Dec 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Periapical DiseasesStudies of the same condition, open and under way.
- More trials run by Postgraduate Institute of Dental Sciences RohtakThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 62 participants (actual)
Sponsor and investigators
- Lead sponsor
- Postgraduate Institute of Dental Sciences Rohtak
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jigyasa grover, MDS, Study director, PGIDS ROHTAK, HARYANAsanjay Tewari, MDS, Study chair, PGIDS ROHTAK HARYANAMOHAMMED MUZAFFAR KHAN, BDS, Principal investigator, PGIDS ROHTAK HARYANA
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06643676
- Sponsor's protocol ID
- Muzaffar Khan
- Status last verified
- Sep 2026
- First submitted
- 12 Jul 2024
- Last updated
- 17 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Targeted Endodontic Microsurgery on Quality of Life and Healing on Mandibular Molars : A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06643676
- Acronym / sponsor ID
- Muzaffar Khan
- Conditions
- Periapical Diseases, Periapical Periodontitis, Periapical Cyst, Periapical Granuloma, Periapical Pathology, Endodontic Microsurgery
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 62 participants (actual)
- Lead sponsor
- Postgraduate Institute of Dental Sciences RohtakUniversity, hospital or other
- Study start
- 1 Jul 2024 (actual)
- Primary completion
- 15 Dec 2025 (actual)
- Study completion
- 31 Dec 2025 (actual)
- First posted
- 16 Oct 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Targeted endodontic microsurgery represents precise and advanced approach to resolving persisting chronic periapical periodontitis after non- surgical root canal treatment. This specialised procedure involves accessing the root tip of the tooth under high magnification using dental operating microscopes and employing microsurgical instruments to remove infected or inflamed tissue, as well as any pathological lesions present in the periapical region. Targeted Endodontic Microsurgery is useful for osteotomy and root- end resection when exacting control of depth, diameter, and angulation of osteotomy and root end resection is necessary. Using a CBCT(cone beam computed tomography) designed 3D - printed surgical guideis a more accurate method for access to the apical portion of the root during surgical endodontics compared with a "freehand" CBCT - approximated conventional method. These guided have the potential to increase accuracy and precision and to reduce intraoperative time as well as postoperative complications. Additionally, it provides a viable treatment option for patients who may not be candidates for traditional root canal therapy or retreatment due to anatomical complexities or previous treatment failures.
Detailed description
Conventional Endodontic microsurgery takes use of a preoperative scan and manual drilling of the osteotomy site with arbitrary measurements followed by retropreparation and forming the apical seal. One of the most critical disadvantages of conventional root-end resection include the damage to anatomically vital structures such as inferior dental nerve, mental nerve, adjacent root and maxillary sinus. In contrast, endodontic microsurgery using the guide template significantly reduces these damages. Pinsky et al confirmed in their in vitro study that the greater accuracyand consistency was achieved during endodontic surgery with surgical guidance without damaging vital structures. An error greater than 3 mm occurred over 22% of the time with freehand whereas none of errors occurred with surgical guidance.
Consequently, targeted endodontic microsurgery has garnered increasing attention as a viable alternative, offering a refined and precise approach to address such challenges.
Even the most skilled surgeons may find endodontic microsurgery difficult. Some medical professionals steer clear using freehand (FH) Endodontic microsurgery in regions where there is a chance of harming important anatomical features including the maxillary sinus, the mental foramen, and arteries. It is Perceived as complex sites include those with limited access, no direct sight, and areas where the apex is placed distant from the buccal cortical bone without any cortical plate fenestratio. Surgeons may be able to perform precise procedures in difficult-to-reach regions with guided Endodontic Microsurgery
Guided Endodontic Microsurgery is virtually planned on 3D software on the preoperative CBCT scan, and the surgeon executes the osteotomy and root-end resection (RER) under static or dynamic navigation.
Static navigation requires a customized 3D-printed surgical guide (3D-SG) to guide the drilling duringosteotomy and RER. Surgical guides contain a guide template that refers to the 3D location of the virtual Endodontic Microsurgery planned in the CBCT to drill accurately Prior research has demonstrated that 3D-SG can reduce the risk of intra-operative complications whileincreasing the precision and effectiveness of EMS. In comparison to free hand Endodontic Microsurgery, guided Endodontic Microsurgery with 3D-Surgical Guide shortens the surgical time, provides superior control over the resection level and bevel off the root, and enables a tailored osteotomy size.
Trephine burs have been used for the removal of failed implants and autogenous bone graft harvesting but have not previously been described in Endodontic Microsurgery .
Targeted Endodontic Microsurgery produces a single-step osteotomy; root-end resection; and biopsy with a defined perforation site, angulation, depth, and diameter. Previous reports have used 3D Surgical Guides to locate an ideal bone perforation site, but none have used trephine burs within a stent to define all parameters of osteotomy and root-end resection.
Also, no clinical study assessing the targeted approach of endodontic microsurgery with Oral health related quality of life has been done. Some of the RCT's are conducted assessing quality of life in patients after conventional periapical surgery, only two retrospective studies considering .Targeted Endodontic Microsurgery have been done and a lack of RCTs comparing targeted Endodontic Microsurgery with conventionalEMS warrants further research.
The aim of this study is to compare the effect of a static computer-aided surgical technique using a 3D- printed guide with a fully guided drill protocol on Oral Health Related Quality of Life against the conventional endodontic microsurgery in mandibular molars.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Targeted Endodontic Microsurgery using trephine drill and 3d printed surgical guide | Experimental | Procedure: Targeted Endodontic Microsurgery Using 3d Printed surgical guide using the patient's CBCT dataEndodontic Microsurgery using 3d printed static surgical guide using patient's cbct data |
| Conventional Endodontic microsurgery using burs | Active comparator | Procedure: Conventional Endodontic Microsurgery with a free hand procedure using bur and CBCT analysisConventional Endodontic microsurgery using carbide bur and free hand conventional procedure |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (10 listed)
- Patients with persistent symptomatic Or asymptomatic apical periodontitis and periapical radiolucency.
- Previous history of Root canal retreatment.
- Tooth with a peri-radicular lesion of strictly endodontic origin KIM's Classification A,B,C)
- Patients between 18-55 years of age.
- No general medical contraindications for oral surgical procedures (ASA-1) according to the classification of the American Society of Anesthesiologists)
Key exclusion criteria (8 listed)
- Patients with systemic diseases (diabetes mellitus, uncontrolled hypertension grade III, hepatic/renal disease, or systemic bleeding disorders)
- Patients on anticoagulant/ antiplatelet drugs.
- Fractured/perforated teeth.
- Teeth with deep pockets (probing depth > 4 mm).
- Presence of vertical root fracture.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Targeted Endodontic Microsurgery Using 3d Printed surgical guide using the patient's CBCT dataAlso: periapical surgery, Targeted Endodontic Microsurgery, Guided Endodontic Microsurgery, apicoectomyPatients with apical periodontitis with intact cortex in madibular molars receiving Targeted Endodontic surgery or Guided Endodontic Microsurgery with surgical guide fabricated using the cbct data following failure of non surgical root canal treatment | Procedure or surgery | Targeted Endodontic Microsurgery using trephine drill and 3d printed surgical guide |
| Conventional Endodontic Microsurgery with a free hand procedure using bur and CBCT analysisA conventional endodontic microsurgery using arbitrary localisation technique using the cbct data and performing the surgery with a carbide bur. | Procedure or surgery | Conventional Endodontic microsurgery using burs |
Primary outcome
Quality of life following periapical surgery
Time frame: 1 year
Quality of life quantified using Questionnaire to both groups
3 secondary outcomes
Radiographic healing
Time frame: 1 year
Time Taken for surgery(Till osteotomy and root end resection)
Time frame: one year
Accuracy of surgical access
Time frame: one year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Sep 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jigyasa grover, MDS study director
PGIDS ROHTAK, HARYANA
sanjay Tewari, MDS study chair
PGIDS ROHTAK HARYANA
MOHAMMED MUZAFFAR KHAN, BDS principal investigator
PGIDS ROHTAK HARYANA
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Targeted Endodontic Microsurgery Using 3d Printed surgical guide using the patient's CBCT data and Conventional Endodontic Microsurgery with a free hand procedure using bur and CBCT analysis in people with Periapical Diseases and Periapical Periodontitis, run by Postgraduate Institute of Dental Sciences Rohtak at 1 site in India.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in India. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Quality of life following periapical surgery (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Sep 2026.