Periapical DiseasesNCT04333940
Impact of Periapical Radiography and Cone Beam Computed Tomography on Periapical Assessment Following Surgical Endodontic Treatment
A study testing periapical surgery in people with Periapical Diseases, run by Postgraduate Institute of Dental Sciences Rohtak at 1 site in India.
Trial summary
This study will compare Cone beam Computed Tomography and Periapical radiography in detection and measurement of periapical lesions and healing outcomes following periapical surgery. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Periapical Diseases
- What is being tested?
- periapical surgery
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteIndia
- Study dates
- 1 Jan 2019to 1 Aug 2020
- 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 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Patient willingness to participate in the study.
- Patient's age more than 18 years.
- Failed root canal treated permanent teeth with post-treatment apical periodontitis requiring treatment.
- Patients referred for periapical surgery of permanent teeth because of separated instrument fragment, overextended root canal filling material or any other idiopathic reasons.
- Radiographic evidence of periapical radiolucency in failed root canal treated teeth.
- American classification of anesthesiologists (ASA) Class I or ASA Class 2 according to ASA classification.
Who cannot join
- Positive history of antibiotic use within past three months of the treatment.
- Positive history of analgesic use within the past 7 days.
- Procedural errors in previous root canal treatment which are not manageable.
- Patients who are pregnant, diabetic, having human immunodeficiency virus infection or other immune compromising conditions, had serious medical illness or requiring antibiotic premedication.
- Patients with unrestorable lesions, fractures involving the root and periodontium, and/or periodontally compromised teeth.
Trial locations and contacts
1 site in 1 country.
About this study
This study will compare Cone beam Computed Tomography and Periapical radiography in detection and measurement of periapical lesions and healing outcomes following periapical surgery.
Read the detailed description
Study will be conducted in Post Graduate Institute of Dental Sciences, Rohtak in the department of Conservative Dentistry \& Endodontics.
Study Design: - Prospective clinical trial
Time Frame: - Jan 2019 to April 2020
Population / Participants: -Patients of age 18 years and above will be enrolled in the study.
Sample size: - The anticipated change in treatment plan was expected to be 53% before and after using CBCT. Based on the available data , sample size was calculated to enroll a minimum of 18 patients in each group with a power level of 90% and alpha at the 5% level. Considering the dropouts, a total of 50 patients (n=25 each group) will be recruited for the study.
Method: - Study subjects will be recruited from the pool of patients enrolling in the Outpatient department meeting the inclusion criteria in the Post Graduate Department of Conservative Dentistry \& Endodontics at PGIDS, Rohtak ,Haryana. Study will be performed after obtaining due ethical clearance from Institutional Ethical Committee of PGIDS. Patients are randomly divided into 2Dimensional periapical radiography (PA) group and 3Dimensional Cone beam computed tomography (CBCT) group. Preoperative radiographs (both PA radiography and CBCT) will be taken and periapical surgical procedures will be carried out under operating microscope by the standardized treatment methods.
Surgical Technique:
With the exception of incisions, flap elevation and suturing, all surgical procedures will be performed under operating microscope in an operating room under 8x to 16x magnification.
The full thickness (mucoperiosteal flap) will be reflected under aseptic conditions -
- Preoperative mouth rinse with 0.2% chlorhexidine mouthwash will be used.
- Local anaesthesia with lidocaine 2% with epinephrine 1:1,00,000 will be achieved.
- Buccal intrasulcular incision will be given up to the alveolar crest including one tooth mesial to the lesion \& one tooth distal to the lesion, using no.15 BP blade.
- Mesial and distal vertical releasing incision will be given.
- Full thickness flap will be gently reflected towards the apical area by periosteal elevator. The flap will be frequently irrigated with sterile saline to prevent dehydration of periosteal surface.
- After complete elevation of the flap, bone cutting is done using bur and complete debridement of the bony lesion will be performed by surgical curettes For additional hemostasis during surgery cotton pellets soaked in 0.1% epinephrine will be applied topically as required.
- A 2-3mm root tip with a 0º to 10º bevel angle will be resected with cylindrical surgical carbide bur at high speed with sterile water coolant.
- Root end preparations extending 3mm into the canal space along the long axis of the root will be made using piezoelectric ultrasonic retrotips in both groups.
- Isthmuses, fins, and other significant anatomic irregularities will be identified in high magnification and will be treated with the ultrasonic instruments.
- Root end filling will be done with mineral trioxide aggregrate (MTA). The adaptation of the filling material to the canal apical walls will be confirmed with the aid of an operating microscope at high magnification.
- Later wound site will be closed and sutured with 4-0 silk suture after irrigating the defect properly.
Post - Operative Follow-Up:
Clinical and 2D periapical radiographic examinations will be performed every 3, 6, 9 and 12 months by assessing the same parameters as baseline except that PD, CAL will not be measured until 12 months .CBCT scan will be done at 12 months follow up . Routine examination procedure will be used to evaluate any evidence of clinical signs and/or symptoms. Postoperative complications and Oral Health Related Quality of Life (OHQoL) questionnaire response will be assessed.
Healing Outcome measurement:
2D Radiographic healing will be assessed by the criteria followed by Rud et al (1972) and Molven et al (1987) Score 1 - Complete healing, defined by re-establishment of the lamina dura Score 2 - Incomplete healing (scar tissue) Score 3 - Uncertain healing Score 4 - Unsatisfactory healing (failure)
Patient assessment of quality of life following surgical endodontic treatment:
Each patient received a questionnaire to fill out for each day starting the day of surgery for 7 days postoperatively. The questionnaire consisted of 15 questions in which patients were to evaluate their quality of life with the 5-point Likert- type scale, ranging from 1 (not at all) to 5 (very much).
3 Dimensionally at 12 months of follow up periapical healing will be assessed by modified PENN 3D criteria: Score 1 - Complete healing Score 2 - Limited healing Score 3 - Uncertain healing Score 4 - Unsatisfactory healing
- Conditions
- Periapical Diseases
- Being tested
- periapical surgery
- Medical subject headings
- Periapical Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
periapical surgeryProcedure or surgery
clinical signs and symptoms, probing depth, Clinical attachment level (CAL ), dimensions of lesion, distance from the defect and apex of tooth to the anatomical structures will be measured
| Study group | Role | What they receive |
|---|---|---|
| 1. 3D CBCT GROUP | Experimental | Preoperative 3-dimensional CBCT will be taken. Receives: Procedure: periapical surgery |
| 2D PR GROUP | Active comparator | Preoperative 2-dimensional periapical radiographs will be taken using paralleling technique with customized Jig Receives: Procedure: periapical surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative healing
Radiographic healing will be assessed in periapical radiography and CBCT after 12 months
Measured: 12 months
Secondary outcomes (1)
Quality of life assessment
likert scale of 1 to 5 1- not at all 5 - very much
Measured: till 1 wek after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Apr 2020
- Study start1 Jan 2019
- Primary completion1 Apr 2020
- Study completion1 Aug 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- 50 participants (actual)
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
- NCT04333940
- Sponsor's protocol ID
- Dr. G.Keerthana
- Status last verified
- Dec 2020
- First submitted
- 1 Apr 2020
- Last updated
- 14 Dec 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Gurusamy K, Duhan J, Tewari S, Sangwan P, Gupta A, Mittal S, Kumar V, Arora M. Patient-centric outcome assessment of endodontic microsurgery using periapical radiography versus cone beam computed tomography: A randomized clinical trial. Int Endod J. 2023 Jan;56(1):3-16. doi: 10.1111/iej.13837. Epub 2022 Oct 2.
PubMed 36135595
Study at a glance
From the registry record, last updated by the sponsor on 14 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Periapical Radiography and Cone Beam Computed Tomography on Periapical Assessment Following Surgical Endodontic Treatment
- ClinicalTrials.gov ID
- NCT04333940
- Acronym / sponsor ID
- Dr. G.Keerthana
- Conditions
- Periapical Diseases
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Postgraduate Institute of Dental Sciences RohtakUniversity, hospital or other
- Study start
- 1 Jan 2019 (actual)
- Primary completion
- 1 Apr 2020 (actual)
- Study completion
- 1 Aug 2020 (actual)
- First posted
- 3 Apr 2020 (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.
This study will compare Cone beam Computed Tomography and Periapical radiography in detection and measurement of periapical lesions and healing outcomes following periapical surgery.
Detailed description
Study will be conducted in Post Graduate Institute of Dental Sciences, Rohtak in the department of Conservative Dentistry \& Endodontics.
Study Design: - Prospective clinical trial
Time Frame: - Jan 2019 to April 2020
Population / Participants: -Patients of age 18 years and above will be enrolled in the study.
Sample size: - The anticipated change in treatment plan was expected to be 53% before and after using CBCT. Based on the available data , sample size was calculated to enroll a minimum of 18 patients in each group with a power level of 90% and alpha at the 5% level. Considering the dropouts, a total of 50 patients (n=25 each group) will be recruited for the study.
Method: - Study subjects will be recruited from the pool of patients enrolling in the Outpatient department meeting the inclusion criteria in the Post Graduate Department of Conservative Dentistry \& Endodontics at PGIDS, Rohtak ,Haryana. Study will be performed after obtaining due ethical clearance from Institutional Ethical Committee of PGIDS. Patients are randomly divided into 2Dimensional periapical radiography (PA) group and 3Dimensional Cone beam computed tomography (CBCT) group. Preoperative radiographs (both PA radiography and CBCT) will be taken and periapical surgical procedures will be carried out under operating microscope by the standardized treatment methods.
Surgical Technique:
With the exception of incisions, flap elevation and suturing, all surgical procedures will be performed under operating microscope in an operating room under 8x to 16x magnification.
The full thickness (mucoperiosteal flap) will be reflected under aseptic conditions -
- Preoperative mouth rinse with 0.2% chlorhexidine mouthwash will be used.
- Local anaesthesia with lidocaine 2% with epinephrine 1:1,00,000 will be achieved.
- Buccal intrasulcular incision will be given up to the alveolar crest including one tooth mesial to the lesion \& one tooth distal to the lesion, using no.15 BP blade.
- Mesial and distal vertical releasing incision will be given.
- Full thickness flap will be gently reflected towards the apical area by periosteal elevator. The flap will be frequently irrigated with sterile saline to prevent dehydration of periosteal surface.
- After complete elevation of the flap, bone cutting is done using bur and complete debridement of the bony lesion will be performed by surgical curettes For additional hemostasis during surgery cotton pellets soaked in 0.1% epinephrine will be applied topically as required.
- A 2-3mm root tip with a 0º to 10º bevel angle will be resected with cylindrical surgical carbide bur at high speed with sterile water coolant.
- Root end preparations extending 3mm into the canal space along the long axis of the root will be made using piezoelectric ultrasonic retrotips in both groups.
- Isthmuses, fins, and other significant anatomic irregularities will be identified in high magnification and will be treated with the ultrasonic instruments.
- Root end filling will be done with mineral trioxide aggregrate (MTA). The adaptation of the filling material to the canal apical walls will be confirmed with the aid of an operating microscope at high magnification.
- Later wound site will be closed and sutured with 4-0 silk suture after irrigating the defect properly.
Post - Operative Follow-Up:
Clinical and 2D periapical radiographic examinations will be performed every 3, 6, 9 and 12 months by assessing the same parameters as baseline except that PD, CAL will not be measured until 12 months .CBCT scan will be done at 12 months follow up . Routine examination procedure will be used to evaluate any evidence of clinical signs and/or symptoms. Postoperative complications and Oral Health Related Quality of Life (OHQoL) questionnaire response will be assessed.
Healing Outcome measurement:
2D Radiographic healing will be assessed by the criteria followed by Rud et al (1972) and Molven et al (1987) Score 1 - Complete healing, defined by re-establishment of the lamina dura Score 2 - Incomplete healing (scar tissue) Score 3 - Uncertain healing Score 4 - Unsatisfactory healing (failure)
Patient assessment of quality of life following surgical endodontic treatment:
Each patient received a questionnaire to fill out for each day starting the day of surgery for 7 days postoperatively. The questionnaire consisted of 15 questions in which patients were to evaluate their quality of life with the 5-point Likert- type scale, ranging from 1 (not at all) to 5 (very much).
3 Dimensionally at 12 months of follow up periapical healing will be assessed by modified PENN 3D criteria: Score 1 - Complete healing Score 2 - Limited healing Score 3 - Uncertain healing Score 4 - Unsatisfactory healing
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1. 3D CBCT GROUP | Experimental | Procedure: periapical surgeryPreoperative 3-dimensional CBCT will be taken. |
| 2D PR GROUP | Active comparator | Procedure: periapical surgeryPreoperative 2-dimensional periapical radiographs will be taken using paralleling technique with customized Jig |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Patient willingness to participate in the study.
- Patient's age more than 18 years.
- Failed root canal treated permanent teeth with post-treatment apical periodontitis requiring treatment.
- Patients referred for periapical surgery of permanent teeth because of separated instrument fragment, overextended root canal filling material or any other idiopathic reasons.
- Radiographic evidence of periapical radiolucency in failed root canal treated teeth.
Key exclusion criteria (5 listed)
- Positive history of antibiotic use within past three months of the treatment.
- Positive history of analgesic use within the past 7 days.
- Procedural errors in previous root canal treatment which are not manageable.
- Patients who are pregnant, diabetic, having human immunodeficiency virus infection or other immune compromising conditions, had serious medical illness or requiring antibiotic premedication.
- Patients with unrestorable lesions, fractures involving the root and periodontium, and/or periodontally compromised teeth.
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 |
|---|---|---|
| periapical surgeryclinical signs and symptoms, probing depth, Clinical attachment level (CAL ), dimensions of lesion, distance from the defect and apex of tooth to the anatomical structures will be measured | Procedure or surgery | 1. 3D CBCT GROUP, 2D PR GROUP |
Primary outcome
Postoperative healing
Time frame: 12 months
Radiographic healing will be assessed in periapical radiography and CBCT after 12 months
1 secondary outcome
Quality of life assessment
Time frame: till 1 wek after surgery
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 14 Dec 2020.
- Derived from this study: PubMed 36135595Gurusamy K, Duhan J, Tewari S, Sangwan P, Gupta A, Mittal S, Kumar V, Arora M. Patient-centric outcome assessment of endodontic microsurgery using periapical radiography versus cone beam computed tomography: A randomized clinical trial. Int Endod J. 2023 Jan;56(1):3-16. doi: 10.1111/iej.13837. Epub 2022 Oct 2.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing periapical surgery in people with Periapical Diseases, 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 6 inclusion and 5 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 14 Dec 2020. 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?
Postoperative healing (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04333940, which also lists 1 linked publication.
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 14 Dec 2020.