Periapical LesionNCT06642415
Effect Of High Magnification On Quality Of Life And Success After Endodontic Microsurgery: A Randomized Controlled Trial
A study testing Surgery under loupes and surgery performed under microscope in people with Periapical Lesion, run by Postgraduate Institute of Dental Sciences Rohtak at 1 site in India.
Trial summary
Effect of high magnification on quality of life and success after endodontic surgery: a randomized controlled trial" Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Periapical Lesion
- What is being tested?
- Surgery under loupes and surgery performed under microscope
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteIndia
- Study dates
- 1 Nov 2023to 1 May 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 between age of 18-55 with the diagnosis of persistent symptomatic apical periodontitis in previously treated teeth with radiographic evidence of periapical radiolucency (≥ 5 mm). (Bharathi et al 2021) Tooth with a peri radicular lesion of strictly endodontic origin and unrestorable by nonsurgical retreatment. ASA-1 patients according to the classification of the American Society of Anesthesiologists).
Who cannot join
- Patients with systemic diseases (diabetes mellitus, uncontrolled hypertension grade III, hepatic/renal disease, or systemic bleeding disorders) Combined endodontic-periodontic lesions Pregnancy
- -
Trial locations and contacts
1 site in 1 country.
India1 site, 1 recruiting
- Recruiting
PGIDS
Rohtak, Haryana, 124001
DR. Sanjay Tewari, MDS, 09416259534, principalpgids@gmail.com
Jyoti Nadekar, PG student, 8689830886, jyotinadekar25@gmail.com
About this study
Effect of high magnification on quality of life and success after endodontic surgery: a randomized controlled trial"
Read the detailed description
: Residual infection in untreated canal space is one of the most common cause of post treatment apical periodontitis. The prevalence of post treatment apical periodontitis has been reported to be 60% to 80%. Endodontic microsurgery and root resection removes the inaccessible apical ramifications and ensures adequate sealing of apical communication. Magnification has been recommended for better visualization of apical terminus. Various case reports and retrospective studies have reported higher success of apical surgery when magnification devices have been used as an adjunct to periapical surgery (setzer 2010, tsesis 2006, bud 2020). However, there are very few prospective studies and there is heterogeneity in data in terms of type of magnification used and there are very few studies comparing different magnification devices.
To the best of our knowledge no randomized controlled trial has been done on the periapical surgery of maxillary anterior teeth which compares the effect of magnification by microscope versus loupes, hence the aim of this study is to assess the quality of life and success after endodontic surgery using with or without magnification.
- Conditions
- Periapical Lesion
- Being tested
- Surgery under loupes, surgery performed under microscope
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Surgery under loupesProcedure or surgery
surgery performed under loupes
surgery performed under microscopeProcedure or surgery
surgery performed under microscope
| Study group | Role | What they receive |
|---|---|---|
| Loupes group | Active comparator | Surgery performed under loupes Receives: Procedure: Surgery under loupes; Procedure: surgery performed under microscope |
| Microscope group | Experimental | Surgery performed under microscope Receives: Procedure: Surgery under loupes; Procedure: surgery performed under microscope |
What is being measured
The primary outcome is the main question the study is designed to answer.
Quality of life assessment
To determine the quality of life after endodontic microsurgery with high and low magnification using modified version of sugars et al and OHIP by tsesis et al. assessed by 5-point Likert scale till 1 week.
Measured: till 7 days after surgery
Healing assessment
2D radiographic healing was assessed by the criteria followed by RUD et al and MOLVEN et al , 3D CBCT healing was assessed by modified PENN'S criteria
Measured: After 6 months and 12 months
Secondary outcomes (1)
Pain assessment
Pain assessment by VAS (0 - 100), where 0 is no pain and 100 is worst possible pain.
Measured: till 7 postoperative days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Oct 2024
- Study start1 Nov 2023
- Primary completion1 Apr 2024
- Study completion1 May 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Periapical LesionStudies 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
- Single blind
- Who is masked
- Participant
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Postgraduate Institute of Dental Sciences Rohtak
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06642415
- Sponsor's protocol ID
- Jyoti Dnyaneshwar Nadekar
- Status last verified
- Oct 2024
- First submitted
- 12 Oct 2024
- Last updated
- 15 Oct 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect Of High Magnification On Quality Of Life And Success After Endodontic Microsurgery: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06642415
- Acronym / sponsor ID
- Jyoti Dnyaneshwar Nadekar
- Conditions
- Periapical Lesion
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Postgraduate Institute of Dental Sciences RohtakUniversity, hospital or other
- Study start
- 1 Nov 2023 (actual)
- Primary completion
- 1 Apr 2024 (actual)
- Study completion
- 1 May 2025 (estimated)
- First posted
- 15 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.
Effect of high magnification on quality of life and success after endodontic surgery: a randomized controlled trial"
Detailed description
: Residual infection in untreated canal space is one of the most common cause of post treatment apical periodontitis. The prevalence of post treatment apical periodontitis has been reported to be 60% to 80%. Endodontic microsurgery and root resection removes the inaccessible apical ramifications and ensures adequate sealing of apical communication. Magnification has been recommended for better visualization of apical terminus. Various case reports and retrospective studies have reported higher success of apical surgery when magnification devices have been used as an adjunct to periapical surgery (setzer 2010, tsesis 2006, bud 2020). However, there are very few prospective studies and there is heterogeneity in data in terms of type of magnification used and there are very few studies comparing different magnification devices.
To the best of our knowledge no randomized controlled trial has been done on the periapical surgery of maxillary anterior teeth which compares the effect of magnification by microscope versus loupes, hence the aim of this study is to assess the quality of life and success after endodontic surgery using with or without magnification.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Loupes group | Active comparator | Procedure: Surgery under loupes, Procedure: surgery performed under microscopeSurgery performed under loupes |
| Microscope group | Experimental | Procedure: Surgery under loupes, Procedure: surgery performed under microscopeSurgery performed under microscope |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Patients between age of 18-55 with the diagnosis of persistent symptomatic apical periodontitis in previously treated teeth with radiographic evidence of periapical radiolucency (≥ 5 mm). (Bharathi et al 2021) Tooth with a peri radicular lesion of strictly endodontic origin and unrestorable by nonsurgical retreatment. ASA-1 patients according to the classification of the American Society of Anesthesiologists).
Key exclusion criteria (2 listed)
- Patients with systemic diseases (diabetes mellitus, uncontrolled hypertension grade III, hepatic/renal disease, or systemic bleeding disorders) Combined endodontic-periodontic lesions Pregnancy
- -
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 |
|---|---|---|
| Surgery under loupessurgery performed under loupes | Procedure or surgery | Loupes group, Microscope group |
| surgery performed under microscopesurgery performed under microscope | Procedure or surgery | Loupes group, Microscope group |
Primary outcome
Quality of life assessment
Time frame: till 7 days after surgery
To determine the quality of life after endodontic microsurgery with high and low magnification using modified version of sugars et al and OHIP by tsesis et al. assessed by 5-point Likert scale till 1 week.
Healing assessment
Time frame: After 6 months and 12 months
2D radiographic healing was assessed by the criteria followed by RUD et al and MOLVEN et al , 3D CBCT healing was assessed by modified PENN'S criteria
1 secondary outcome
Pain assessment
Time frame: till 7 postoperative days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Oct 2024.
Related trials for Periapical Lesion
Active, not recruiting
Early Healing of Apical Periodontitis After Root Canal Treatment With Bioceramic and Calcium Hydroxide Medicaments: Evaluation Using PAI and ImageJ
Apical Periodontitis, Root Canal Treatment
Not yet recruitingObservational study
Diagnostic Performance of Ai vs Junior Dentists
Diagnosis
Active, not recruitingObservational study
A Retrospective Cohort Study on the Non-Surgical Treatment of Periapical Inflammatory Lesions With Vitapex Paste
Periapical Periodontitis, Periapical Abscess
Active, not recruiting
Effect of Apical Patency on Periapical Lesion Healing
Periapical Lesion, Apical Periodontitis
Recruiting
The Effect of Different Intracanal Medicaments on Periapical Lesion Healing
Periapical Lesion Healing, Apical Periodontitis
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Surgery under loupes and surgery performed under microscope in people with Periapical Lesion, 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 1 inclusion and 2 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: status not confirmed, as of the sponsor's last update on 15 Oct 2024. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact DR. Sanjay Tewari, MDS, MDS (09416259534, tewarisanjayrohtak@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Quality of life assessment (time frame: till 7 days after surgery). The study lists 2 primary outcomes in all. 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 15 Oct 2024.