ChronicNCT03964766
Pulpectomy of Primary Molars With Rotary Instrumentation Versus Manual Instrumentation
A study testing Rotary instrumentation and Hand instrumentation in people with Chronic and Infection, run by Cairo University.
Trial summary
One of the major concerns in pediatric dentistry is premature loss of necrotic primary teeth which may cause a deleterious effect on the growth of the facial skeletal complex. In order to sustain the primary tooth as a natural space maintainer, pulpectomy is considered the treatment of choice. Read more about this study
- Who is it for?
- Ages 4 to 6 yearsHealthy volunteers can take part
- What is being tested?
- Rotary instrumentation and Hand instrumentation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 42 participants
- Where
- No sites listed yet
- Study dates
- Dec 2019to Feb 2022
- 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 4 to 6 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Primary posterior teeth requiring pulpectomy.
- Cooperative patient in age range from 4 to 6 years
- Absence of internal or external pathologic root resorption.
- Presence of adequate coronal tooth structure.
- Two-thirds of each root remaining.
- Parent or guardian agree for participant in the study
Who cannot join
- Excessive mobility.
- Children lacking cooperative ability.
- Children with underlying systemic disease.
- Children with special health care needs.
Trial locations and contacts
No sites are listed yet.
Fatma Abdelgawad, PhD contact
About this study
Official title: Postoperative Pain Following Pulpectomy of Primary Molars With Rotary Instrumentation Versus Manual Instrumentation: A Randomized Clinical Trial
One of the major concerns in pediatric dentistry is premature loss of necrotic primary teeth which may cause a deleterious effect on the growth of the facial skeletal complex. In order to sustain the primary tooth as a natural space maintainer, pulpectomy is considered the treatment of choice.
The essential part of endodontic treatment is to shape and clean the root canal effectively from infected tissue with microbial reduction, whilst maintaining the original configuration without creating any procedural errors . Even though, manual instrumentation as used for that purpose in deciduous teeth, presents some limitation concerning root canal cleaning, anatomical fidelity and chair-side time.
To achieve successful pulpectomy technique for the primary dentition in a fast and simple procedure, with short chair time as well as effective debridement of the root canals, rotary instrumentation is one of the methods recommended over the manual.
Read the detailed description
- Trial design: Randomized clinical trial, parallel groups design with 1:1 allocation ratio.
- Method: Interventions
- Diagnostic procedure:
- Clinical examination will be done on the dental clinic using mirror and probe to assess the eligibility.
- Diagnosis of the cases will be performed according to guidelines of AAPD 2017 for treatment of vital pulp therapy in primary teeth.
- An individual XCP (Extension Cone Paralleling) index will be prepared for each patient by registering the bite to allow consistent comparisons of the radiographs.
- Preoperative periapical radiograph and photographs will be taken a baseline record.
- Intra operative procedure:
- Local anesthesia administration using articaine 4% with epinephrine 1:100000.
- Rubber dam application and access cavity preparation will be established using a sterile bur.
- Coronal pulp tissue will be removed using sharp large spoon excavator.
- Working length will be determined using no 15 hand K-file that will be kept 2mm short of radiographic apex.
- Then, the root canal preparation will be done
- In control group, hand instrumentation will be carried out using hand K-file up to no. 30 K-file using quarter turn and pull motion.
- In intervention group, rotary instrumentation will be preceded by initial hand instrumentation using no. 15 K-file to check the patency. Then, the rotary instrumentation will be done using the Kedo-S rotary files for primary teeth with D1 and E1.
- Using EDTA gel as a lubricating paste during canal preparation with rotary files.
- Saline irrigation for removal of debris after each file.
- Dryness will be done using paper points size 35 and 40.
- Root canals will be obturated using calcium hydroxide iodoform paste (Metapex). The Metapex syringe willbe inserted into the root canal space, near the apex. The paste will be pressed down into the canals and the syringe will be slowly withdrawn.
- The access cavity will be sealed using GC Fuji IX capsule.
- The immediate postoperative radiograph will be done to reveal optimal filling with metapex.
- After that, stainless steel crowns will be cemented by Ketac Cem.
- Follow up: Clinical and radiographic evaluation will be performed at 1week, 3, 6, 9 and 12 months.
- Criteria for discontinuing or modifying intervention: In case of unsuccessful outcomes of the intervention technique, the case will be managed .
- Recruitment: Recruitment of the patients will be from the outpatient clinic of Pediatric Dentistry and Dental Public Health Department, Cairo University. Screening of patients will continue until the target population is achieved.
- Implementation Co-supervisor; Fatma Korany will assign which participant tooth will be included to either control or intervention groups according to the generated random sequence.
- Masking/blinding:
The radiographic outcomes assessor will be blinded in this study. 8- Data collection, management, and analysis: 9- Data collection methods
Baseline data will be collected by the operator through a paper-based Case Report custom made form (CRF) which will be developed by the research team. It will include the following items:
- Patient serial number.
- Demographic data.
- Patients medical history:
- Past medical history.
- Any present disease or illness.
- Current medication.
- Any specific pre-treatment medication.
- Past dental history.
- Records for current dental condition (intra-oral examination and caries index). The custom made CRF will be developed before online registration of the study protocol. CRF will be anonymous where patients will be identified by their serial number. The full detailed personal data of the patient will be written in a separate sheet having the patient's serial number for further contact with patient, this sheet can be only seen by the operator and the supervisors. The Co-supervisor; Dr.Fatma Korany, will have the role to monitor the process of data collection and check if there is any incomplete CRF.
- Being tested
- Rotary instrumentation, Hand instrumentation
- Keywords
- rotary files, Primary molar, Pulpectomy
- Medical subject headings
- Bronchiolitis Obliterans Syndrome, Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Rotary instrumentationDevice
using pedo rotary files in cleaning and shaping the root canals of infected primary molars
Hand instrumentationDevice
using conventional hand files in cleaning and shaping the root canals of infected primary molars
| Study group | Role | What they receive |
|---|---|---|
| rotary instrumentation | Experimental | endodontic treatment will be performed with the use of pedo rotary files that will be activated by engine Receives: Device: Rotary instrumentation |
| hand istrumentation | Active comparator | endodontic treatment will be performed with the use of conventional hand files Receives: Device: Hand instrumentation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative pain: modified wong-baker pain rating scale
pain will be assessed using modified wong-baker pain rating scale (0-3),(zero)-no pain; ( one)-slight pain; (two)-moderate pain; and (three)-severe pain.
Measured: 12 hours
postoperative pain: modified wong-baker pain rating scale
pain will be assessed using modified wong-baker pain rating scale (0-3),(zero)-no pain; ( one)-slight pain; (two)-moderate pain; and (three)-severe pain.
Measured: 24 hours
postoperative pain: modified wong-baker pain rating scale
pain will be assessed using modified wong-baker pain rating scale (0-3),(zero)-no pain; ( one)-slight pain; (two)-moderate pain; and (three)-severe pain.
Measured: 48 hours
Postoperative pain: modified wong-baker pain rating scale
pain will be assessed using modified wong-baker pain rating scale (0-3),(zero)-no pain; ( one)-slight pain; (two)-moderate pain; and (three)-severe pain.
Measured: 72 hours
Secondary outcomes (5)
Tenderness to percussion
Percussion test ,Binary (+/-)
Measured: Up to 1 year
Fistula
Visual examination by operator,Binary (+/-)
Measured: Up to 1 year
Instrumentation time
The time spent using both techniques will be measured and compared between the groups. The time will be recorded in minutes using a stopwatch since the beginning of instrumentation until the beginning of restorative procedure.
Measured: 15 Minutes
Furcation or periapical radiolucency
Digital Radiograph ,Binary (+/-)
Measured: 6 month
Furcation or periapical radiolucency
Digital Radiograph ,Binary (+/-)
Measured: 12 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 May 2019
- Study startDec 2019 (estimated)
- Primary completionDec 2021 (estimated)
- Study completionFeb 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for ChronicStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe 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
- Outcomes assessor
- Enrolment
- 42 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Azhar Abdulrahman Ali Saleh Al-wesabi, Cairo University
- Investigators
- Fatma Abdelgawad, PhD, Study director, Lecturer of Pediatric DentistryKamal El Motayam, PhD, Study chair, Professor of Pediatric Dentistry
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03964766
- Sponsor's protocol ID
- 200277
- Status last verified
- May 2019
- First submitted
- 16 May 2019
- Last updated
- 19 Jul 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: after thesis defense. the study will be published internationally to be available for everyone
Publications
Panchal V, Jeevanandan G, Subramanian E. Comparison of instrumentation time and obturation quality between hand K-file, H-files, and rotary Kedo-S in root canal treatment of primary teeth: A randomized controlled trial. J Indian Soc Pedod Prev Dent. 2019 Jan-Mar;37(1):75-79. doi: 10.4103/JISPPD.JISPPD_72_18.
PubMed 30804311Makarem A, Ravandeh N, Ebrahimi M. Radiographic assessment and chair time of rotary instruments in the pulpectomy of primary second molar teeth: a randomized controlled clinical trial. J Dent Res Dent Clin Dent Prospects. 2014 Spring;8(2):84-9. doi: 10.5681/joddd.2014.015. Epub 2014 Jun 11.
PubMed 25093051Panchal V, Jeevanandan G, Subramanian EMG. Comparison of post-operative pain after root canal instrumentation with hand K-files, H-files and rotary Kedo-S files in primary teeth: a randomised clinical trial. Eur Arch Paediatr Dent. 2019 Oct;20(5):467-472. doi: 10.1007/s40368-019-00429-5. Epub 2019 Mar 12.
PubMed 30864090
Study at a glance
From the registry record, last updated by the sponsor on 19 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Postoperative Pain Following Pulpectomy of Primary Molars With Rotary Instrumentation Versus Manual Instrumentation: A Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT03964766
- Acronym / sponsor ID
- 200277
- Keywords
- rotary files, Primary molar, Pulpectomy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 42 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- Dec 2019 (estimated)
- Primary completion
- Dec 2021 (estimated)
- Study completion
- Feb 2022 (estimated)
- First posted
- 28 May 2019 (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.
One of the major concerns in pediatric dentistry is premature loss of necrotic primary teeth which may cause a deleterious effect on the growth of the facial skeletal complex. In order to sustain the primary tooth as a natural space maintainer, pulpectomy is considered the treatment of choice.
The essential part of endodontic treatment is to shape and clean the root canal effectively from infected tissue with microbial reduction, whilst maintaining the original configuration without creating any procedural errors . Even though, manual instrumentation as used for that purpose in deciduous teeth, presents some limitation concerning root canal cleaning, anatomical fidelity and chair-side time.
To achieve successful pulpectomy technique for the primary dentition in a fast and simple procedure, with short chair time as well as effective debridement of the root canals, rotary instrumentation is one of the methods recommended over the manual.
Detailed description
- Trial design: Randomized clinical trial, parallel groups design with 1:1 allocation ratio.
- Method: Interventions
- Diagnostic procedure:
- Clinical examination will be done on the dental clinic using mirror and probe to assess the eligibility.
- Diagnosis of the cases will be performed according to guidelines of AAPD 2017 for treatment of vital pulp therapy in primary teeth.
- An individual XCP (Extension Cone Paralleling) index will be prepared for each patient by registering the bite to allow consistent comparisons of the radiographs.
- Preoperative periapical radiograph and photographs will be taken a baseline record.
- Intra operative procedure:
- Local anesthesia administration using articaine 4% with epinephrine 1:100000.
- Rubber dam application and access cavity preparation will be established using a sterile bur.
- Coronal pulp tissue will be removed using sharp large spoon excavator.
- Working length will be determined using no 15 hand K-file that will be kept 2mm short of radiographic apex.
- Then, the root canal preparation will be done
- In control group, hand instrumentation will be carried out using hand K-file up to no. 30 K-file using quarter turn and pull motion.
- In intervention group, rotary instrumentation will be preceded by initial hand instrumentation using no. 15 K-file to check the patency. Then, the rotary instrumentation will be done using the Kedo-S rotary files for primary teeth with D1 and E1.
- Using EDTA gel as a lubricating paste during canal preparation with rotary files.
- Saline irrigation for removal of debris after each file.
- Dryness will be done using paper points size 35 and 40.
- Root canals will be obturated using calcium hydroxide iodoform paste (Metapex). The Metapex syringe willbe inserted into the root canal space, near the apex. The paste will be pressed down into the canals and the syringe will be slowly withdrawn.
- The access cavity will be sealed using GC Fuji IX capsule.
- The immediate postoperative radiograph will be done to reveal optimal filling with metapex.
- After that, stainless steel crowns will be cemented by Ketac Cem.
- Follow up: Clinical and radiographic evaluation will be performed at 1week, 3, 6, 9 and 12 months.
- Criteria for discontinuing or modifying intervention: In case of unsuccessful outcomes of the intervention technique, the case will be managed .
- Recruitment: Recruitment of the patients will be from the outpatient clinic of Pediatric Dentistry and Dental Public Health Department, Cairo University. Screening of patients will continue until the target population is achieved.
- Implementation Co-supervisor; Fatma Korany will assign which participant tooth will be included to either control or intervention groups according to the generated random sequence.
- Masking/blinding:
The radiographic outcomes assessor will be blinded in this study. 8- Data collection, management, and analysis: 9- Data collection methods
Baseline data will be collected by the operator through a paper-based Case Report custom made form (CRF) which will be developed by the research team. It will include the following items:
- Patient serial number.
- Demographic data.
- Patients medical history:
- Past medical history.
- Any present disease or illness.
- Current medication.
- Any specific pre-treatment medication.
- Past dental history.
- Records for current dental condition (intra-oral examination and caries index). The custom made CRF will be developed before online registration of the study protocol. CRF will be anonymous where patients will be identified by their serial number. The full detailed personal data of the patient will be written in a separate sheet having the patient's serial number for further contact with patient, this sheet can be only seen by the operator and the supervisors. The Co-supervisor; Dr.Fatma Korany, will have the role to monitor the process of data collection and check if there is any incomplete CRF.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| rotary instrumentation | Experimental | Device: Rotary instrumentationendodontic treatment will be performed with the use of pedo rotary files that will be activated by engine |
| hand istrumentation | Active comparator | Device: Hand instrumentationendodontic treatment will be performed with the use of conventional hand files |
Who may qualify
- Ages
- 4 to 6 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- Primary posterior teeth requiring pulpectomy.
- Cooperative patient in age range from 4 to 6 years
- Absence of internal or external pathologic root resorption.
- Presence of adequate coronal tooth structure.
- Two-thirds of each root remaining.
Key exclusion criteria (4 listed)
- Excessive mobility.
- Children lacking cooperative ability.
- Children with underlying systemic disease.
- Children with special health care needs.
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 |
|---|---|---|
| Rotary instrumentationusing pedo rotary files in cleaning and shaping the root canals of infected primary molars | Device | rotary instrumentation |
| Hand instrumentationusing conventional hand files in cleaning and shaping the root canals of infected primary molars | Device | hand istrumentation |
Primary outcome
Postoperative pain: modified wong-baker pain rating scale
Time frame: 12 hours
pain will be assessed using modified wong-baker pain rating scale (0-3),(zero)-no pain; ( one)-slight pain; (two)-moderate pain; and (three)-severe pain.
postoperative pain: modified wong-baker pain rating scale
Time frame: 24 hours
pain will be assessed using modified wong-baker pain rating scale (0-3),(zero)-no pain; ( one)-slight pain; (two)-moderate pain; and (three)-severe pain.
postoperative pain: modified wong-baker pain rating scale
Time frame: 48 hours
pain will be assessed using modified wong-baker pain rating scale (0-3),(zero)-no pain; ( one)-slight pain; (two)-moderate pain; and (three)-severe pain.
Postoperative pain: modified wong-baker pain rating scale
Time frame: 72 hours
pain will be assessed using modified wong-baker pain rating scale (0-3),(zero)-no pain; ( one)-slight pain; (two)-moderate pain; and (three)-severe pain.
5 secondary outcomes
Tenderness to percussion
Time frame: Up to 1 year
Fistula
Time frame: Up to 1 year
Instrumentation time
Time frame: 15 Minutes
Furcation or periapical radiolucency
Time frame: 6 month
Furcation or periapical radiolucency
Time frame: 12 month
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jul 2019.
- Background: PubMed 30804311Panchal V, Jeevanandan G, Subramanian E. Comparison of instrumentation time and obturation quality between hand K-file, H-files, and rotary Kedo-S in root canal treatment of primary teeth: A randomized controlled trial. J Indian Soc Pedod Prev Dent. 2019 Jan-Mar;37(1):75-79. doi: 10.4103/JISPPD.JISPPD_72_18.
- Background: PubMed 25093051Makarem A, Ravandeh N, Ebrahimi M. Radiographic assessment and chair time of rotary instruments in the pulpectomy of primary second molar teeth: a randomized controlled clinical trial. J Dent Res Dent Clin Dent Prospects. 2014 Spring;8(2):84-9. doi: 10.5681/joddd.2014.015. Epub 2014 Jun 11.
- Background: PubMed 30864090Panchal V, Jeevanandan G, Subramanian EMG. Comparison of post-operative pain after root canal instrumentation with hand K-files, H-files and rotary Kedo-S files in primary teeth: a randomised clinical trial. Eur Arch Paediatr Dent. 2019 Oct;20(5):467-472. doi: 10.1007/s40368-019-00429-5. Epub 2019 Mar 12.
- Pinheiro, S., Santos, N. \& Imparato, J. (2012) Analysis of the instrumentation time and cleaning between manual and rotary techniques in deciduous molars. Rsbo, 9 (3), pp.238-244.Link provided by the sponsor.
- Ochoa-Romero, T., Veronica Mendez-Gonzalez, H.F.-R. \& Pozos-Guillen, A.J. (2011) Comparison Between Rotary and Manual Techniques on Duration of Instrumentation and Obturation Times in Primary Teeth.Link provided by the sponsor.
- Individual participant dataSharing planned: Yes. after thesis defense. the study will be published internationally to be available for everyone
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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.
Fatma Abdelgawad, PhD contact
Fatma Abdelgawad, PhD study director
Lecturer of Pediatric Dentistry
Kamal El Motayam, PhD study chair
Professor of Pediatric Dentistry
Questions about this trial
What is this clinical trial studying?
A study testing Rotary instrumentation and Hand instrumentation in people with Chronic and Infection, run by Cairo University.
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 4 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 19 Jul 2019. Status can change between updates, so confirm with the study contact before making plans.
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 azhar al-wesabi (01023725522, azharali5255@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Postoperative pain: modified wong-baker pain rating scale (time frame: 12 hours). The study lists 4 primary outcomes in all. 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 NCT03964766, which also lists 3 linked publications.
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 19 Jul 2019.