Necrotic PulpNCT03301259
Postoperative Pain Following Treatment of Asymptomatic Necrotic Mandibular Molars in Single Visit Using Wave-one Reciprocating Instruments Versus One-Shape Rotary Instruments
A study testing One-shape rotationary system in people with Necrotic Pulp, run by Cairo University.
Trial summary
The aim of this study is to evaluate the post treatment pain after instrumentation of root canals with a single file reciprocating (Wave-One Ni Ti file, DENTSPLY Maillefer) or rotary(One Shape, Micro Mega, France) file system in patient with asymptomatic necrotic molars This trial will help to clinically evaluate the… Read more about this study
- Who is it for?
- Ages 25 years and olderHealthy volunteers can take part
- Conditions the study is for
- Necrotic Pulp
- What is being tested?
- One-shape rotationary system
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 42 participants
- Where
- No sites listed yet
- Study dates
- 15 Jan 2018to 15 Aug 2018
- 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 25 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Medically free patients
- Patient's age between 25-50 years.
- Mandibular molars diagnosed clinically as necrotic with normal apical tissues.
- Positive patient's acceptance for participation in the study.
- Both genders are included.
- Patients able to sign informed consent.
- Normal periodontal tissues.
- Normal periapical tissues on the radiograph
Who cannot join
- Patients with complicating systemic disease.
- Having severe pain and/or acute apical abscesses.
- Under the age of 25 years.
- Patients using antibiotics or analgesic 12 hours before the procedures.
- Having multiple teeth that required treatment.
- With non-restorable and/or periodontally compromised teeth.
Show all 9Show fewer
- Retreatment cases
- Presence of sinus tract
- Pregnancy
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Evaluation of the Post Treatment Pain After Instrumentation of Root Canals With a Single File Reciprocating (Wave-One Ni Ti File, DENTSPLY Maillefer) or Rotary(One Shape, Micro Mega, France) File System in Patient With Asymptomatic Necrotic Molars
The aim of this study is to evaluate the post treatment pain after instrumentation of root canals with a single file reciprocating (Wave-One Ni Ti file, DENTSPLY Maillefer) or rotary(One Shape, Micro Mega, France) file system in patient with asymptomatic necrotic molars This trial will help to clinically evaluate the use of reciprocating motion in endodontic treatment in necrotic teeth without periapical lesion therefore reduce the post-obtuation pain
Read the detailed description
The aim of this study is to evaluate the post treatment pain after instrumentation of root canals with a single file reciprocating (Wave-One Ni Ti file, DENTSPLY Maillefer) or rotary(One Shape, Micro Mega, France) file system in patient with asymptomatic necrotic molars This trial will help to clinically evaluate the use of reciprocating motion in endodontic treatment in necrotic teeth without periapical lesion therefore reduce the post-obtuation pain
Sample
if the success rate (no pain) for wave one subjects is 0.3, we will need to study 17 patients in each group to be able to reject the null hypothesis that the failure rates for experimental and control subjects are equal with probability (power) 0.8. the type 1 error probability associated with this test of this null hypothesis. This no is to be increased to total no 42 to compensate for losses during follow up , the sample size was calcukated by the PS program
Patients are recruited for the clinical trial from the clinic of endodontics at the Faculty of Oral and Dental Medicine, Cairo University to meet the target sample size.
A random sequence will be generated by computer software, (http://www.random.org/) in the Center of Evidence Based Dentistry, Cairo University. This table will be kept with a co-investigator
The operator finds an eligible participant, then to assign the Participant to either group according to the generated random sequence.
The operator finds an eligible participant, then to assign the Participant to either group according to the generated random sequence.
We will generate the random sequence, assign the participants to the intervention or control groups.
The operators will enroll the participants after they find the eligible ones.
Outpatients of the clinic of endodontics at the Faculty of Oral and Dental Medicine, Cairo University, Egypt.
- The dental Unit is Adec 200 U.S.A.
- The x-ray Machine is ViVi, S.r.I, Italy
- The x-ray films are Kodac, speed D, size 2 or Digital (RVG)
- The operator is a master degree student in the department of Endodontics
Radiographic examination using periapical radiographic film which shows normal periapical tissues with normal lamina dura and width of the periodontal membrane space and absence of periapical lesion
Assessment of pre-operative pain:
The patients will be asked to record the level of pain on a VAS. The patient will be trained that 0 is no pain, 10 is the worst pain, and he will be asked to estimate the pain from 0 to 10 which then will be scored as follows:
0 No pain. From 1-3 mild pain. From 4-5 moderate pain. From 7-10 severe pain
The standard procedure for both groups in single visit
Standard access cavity will be prepared. Isolation will be performed using rubber dam.
K file 10 or 15 will be used to check the patency of the canal. ENDOFLARE will be used for enlarging the coronal third of the canal in cases which will be treated with One Shape Lubricant gel will be used as a lubricant and 2.5% NaOCl as irrigant. Determination of the working length of canal will be done by electronic apex locator and confirmed by periapical radiograph.
Intervention group Root canal preparation will be done with theWaveOne System with strict adherence to the manufacturer's instructions. After coronal preflaring with File ISO 21 taper 8% instrument with 2.5% sodium hypochlorite as the irrigant, working length was determined and a glide path will created.
The Red file R 25 taper 8% will be used for preparing the mesial canal; and the Black ISO 40 taper 8% file will be used for preparing the distal canals where there is only a single canal.
Control Group: canals will be prepared by OneShape (MICRO-MEGA) rotary nickel-titanium file at 400 rpm. The preparation will be stopped by One Shape N°25 - .06 in mesial canals and distal roots with 2 canals; while in case of a single distal canal, the preparation will be stopped by One Shape apical N°30 - .06 rotary files.
Obturation:
After instrumentation and final irrigation, canals will be dried with paper points.
Teeth will be obturated during the initial appointment using epoxy resin sealer.
All the patients will be asked to take a placebo if they experience pain after the procedures. If the patient experience moderate pain he is allowed to take 50mg diclofenac potassium (cataflam 50mg). Any of the patients with intolerable pain will be requested to visit the clinician for emergency treatment. The patients will be asked to record the no. of pills taken and the time at which it was taken.
Assessment of post-operative pain:
Post-operative pain is defined as any degree of pain that occurs after initiation of root canal treatment, while flare up is defined as the development or continuation of pain and/or swelling after endodontic treatment.
The will be asked to record the level of pain at 6 hours, 24 hours, 48 hours and 7days after obturation.
The patient will be trained that 0 is no pain, 10 is the worst pain that interfere with his daily routine, and he will be asked to estimate the pain as follows:
0 No pain. From 1-3 mild pain. From 4-5 moderate pain. From 7-10 severe pain
- Conditions
- Necrotic Pulp
- Being tested
- One-shape rotationary system
- Keywords
- Necrotic pulp, wave-one, one-shape, periapical lesion
- Medical subject headings
- Dental Pulp Necrosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
One-shape rotationary systemOther
OneShape (MICRO-MEGA) rotary nickel-titanium use roation movement and available in two sizes N°30 - .06 rotary files. , N°25 - .06
| Study group | Role | What they receive |
|---|---|---|
| wave -one reciprocating system | Experimental | The reciprocating single file systems WaveOne (Maillefer, Ballaigues, Switzerland) provide more flexibility of the M-wire Ni-Ti alloy, greater resistance to cyclic fatigue and better handling of narrow and curved canals than the traditional Ni-Ti instruments Root canal preparation will be done with theWaveOne System with strict adherence to the manufacturer's instructions. After coronal preflaring with File ISO 21 taper 8% instrument with 2.5% sodium hypochlorite as the irrigant, working length was determined and a glide path will created.
The Red file R 25 taper 8% will be used for preparing the mesial canal; and the Black ISO 40 taper 8% file will be used for preparing the distal canals where there is only a single canal. Receives: Other: One-shape rotationary system |
| OneShape | Experimental | OneShape (MICRO-MEGA) rotary nickel-titanium use roation movement and available in two sizes N°30 - .06 rotary files. , N°25 - .06 Receives: Other: One-shape rotationary system |
What is being measured
The primary outcome is the main question the study is designed to answer.
Post operative pain
Post operative pain after mechanical preparation with wave one and one shape using VAS scale from 0 to 10
Post-operative pain is defined as any degree of pain that occurs after initiation of root canal treatment, while flare up is defined as the development or continuation of pain and/or swelling after endodontic treatment.
The will be asked to record the level of pain at 6 hours, 24 hours, 48 hours and 7days after obturation.
The patient will be trained that 0 is no pain, 10 is the worst pain that interfere with his daily routine, and he will be asked to estimate the pain as follows:
0 No pain. From 1-3 mild pain. From 4-5 moderate pain. From 7-10 severe pain
Measured: changes after 6 hours , 24 hours , 48 hours , 7 days The patient will be trained that 0 is no pain, 10 is the worst pain that interfere with his daily routine, and he will be asked to estimate the pain from 0 to 10
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Oct 2017
- Study start15 Jan 2018 (estimated)
- Primary completion15 May 2018 (estimated)
- Study completion15 Aug 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Necrotic PulpStudies 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
- None (open label)
- Enrolment
- 42 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahmed Ragab Mohamed, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03301259
- Sponsor's protocol ID
- CEBC-CU-2017-06-17
- Status last verified
- Dec 2017
- First submitted
- 24 Sep 2017
- Last updated
- 5 Dec 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 5 Dec 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Post Treatment Pain After Instrumentation of Root Canals With a Single File Reciprocating (Wave-One Ni Ti File, DENTSPLY Maillefer) or Rotary(One Shape, Micro Mega, France) File System in Patient With Asymptomatic Necrotic Molars
- ClinicalTrials.gov ID
- NCT03301259
- Acronym / sponsor ID
- CEBC-CU-2017-06-17
- Conditions
- Necrotic Pulp
- Keywords
- Necrotic pulp, wave-one, one-shape, periapical lesion
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 42 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 15 Jan 2018 (estimated)
- Primary completion
- 15 May 2018 (estimated)
- Study completion
- 15 Aug 2018 (estimated)
- First posted
- 4 Oct 2017 (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.
The aim of this study is to evaluate the post treatment pain after instrumentation of root canals with a single file reciprocating (Wave-One Ni Ti file, DENTSPLY Maillefer) or rotary(One Shape, Micro Mega, France) file system in patient with asymptomatic necrotic molars This trial will help to clinically evaluate the use of reciprocating motion in endodontic treatment in necrotic teeth without periapical lesion therefore reduce the post-obtuation pain
Detailed description
The aim of this study is to evaluate the post treatment pain after instrumentation of root canals with a single file reciprocating (Wave-One Ni Ti file, DENTSPLY Maillefer) or rotary(One Shape, Micro Mega, France) file system in patient with asymptomatic necrotic molars This trial will help to clinically evaluate the use of reciprocating motion in endodontic treatment in necrotic teeth without periapical lesion therefore reduce the post-obtuation pain
Sample
if the success rate (no pain) for wave one subjects is 0.3, we will need to study 17 patients in each group to be able to reject the null hypothesis that the failure rates for experimental and control subjects are equal with probability (power) 0.8. the type 1 error probability associated with this test of this null hypothesis. This no is to be increased to total no 42 to compensate for losses during follow up , the sample size was calcukated by the PS program
Patients are recruited for the clinical trial from the clinic of endodontics at the Faculty of Oral and Dental Medicine, Cairo University to meet the target sample size.
A random sequence will be generated by computer software, (http://www.random.org/) in the Center of Evidence Based Dentistry, Cairo University. This table will be kept with a co-investigator
The operator finds an eligible participant, then to assign the Participant to either group according to the generated random sequence.
The operator finds an eligible participant, then to assign the Participant to either group according to the generated random sequence.
We will generate the random sequence, assign the participants to the intervention or control groups.
The operators will enroll the participants after they find the eligible ones.
Outpatients of the clinic of endodontics at the Faculty of Oral and Dental Medicine, Cairo University, Egypt.
- The dental Unit is Adec 200 U.S.A.
- The x-ray Machine is ViVi, S.r.I, Italy
- The x-ray films are Kodac, speed D, size 2 or Digital (RVG)
- The operator is a master degree student in the department of Endodontics
Radiographic examination using periapical radiographic film which shows normal periapical tissues with normal lamina dura and width of the periodontal membrane space and absence of periapical lesion
Assessment of pre-operative pain:
The patients will be asked to record the level of pain on a VAS. The patient will be trained that 0 is no pain, 10 is the worst pain, and he will be asked to estimate the pain from 0 to 10 which then will be scored as follows:
0 No pain. From 1-3 mild pain. From 4-5 moderate pain. From 7-10 severe pain
The standard procedure for both groups in single visit
Standard access cavity will be prepared. Isolation will be performed using rubber dam.
K file 10 or 15 will be used to check the patency of the canal. ENDOFLARE will be used for enlarging the coronal third of the canal in cases which will be treated with One Shape Lubricant gel will be used as a lubricant and 2.5% NaOCl as irrigant. Determination of the working length of canal will be done by electronic apex locator and confirmed by periapical radiograph.
Intervention group Root canal preparation will be done with theWaveOne System with strict adherence to the manufacturer's instructions. After coronal preflaring with File ISO 21 taper 8% instrument with 2.5% sodium hypochlorite as the irrigant, working length was determined and a glide path will created.
The Red file R 25 taper 8% will be used for preparing the mesial canal; and the Black ISO 40 taper 8% file will be used for preparing the distal canals where there is only a single canal.
Control Group: canals will be prepared by OneShape (MICRO-MEGA) rotary nickel-titanium file at 400 rpm. The preparation will be stopped by One Shape N°25 - .06 in mesial canals and distal roots with 2 canals; while in case of a single distal canal, the preparation will be stopped by One Shape apical N°30 - .06 rotary files.
Obturation:
After instrumentation and final irrigation, canals will be dried with paper points.
Teeth will be obturated during the initial appointment using epoxy resin sealer.
All the patients will be asked to take a placebo if they experience pain after the procedures. If the patient experience moderate pain he is allowed to take 50mg diclofenac potassium (cataflam 50mg). Any of the patients with intolerable pain will be requested to visit the clinician for emergency treatment. The patients will be asked to record the no. of pills taken and the time at which it was taken.
Assessment of post-operative pain:
Post-operative pain is defined as any degree of pain that occurs after initiation of root canal treatment, while flare up is defined as the development or continuation of pain and/or swelling after endodontic treatment.
The will be asked to record the level of pain at 6 hours, 24 hours, 48 hours and 7days after obturation.
The patient will be trained that 0 is no pain, 10 is the worst pain that interfere with his daily routine, and he will be asked to estimate the pain as follows:
0 No pain. From 1-3 mild pain. From 4-5 moderate pain. From 7-10 severe pain
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| wave -one reciprocating system | Experimental | Other: One-shape rotationary systemThe reciprocating single file systems WaveOne (Maillefer, Ballaigues, Switzerland) provide more flexibility of the M-wire Ni-Ti alloy, greater resistance to cyclic fatigue and better handling of narrow and curved canals than the traditional Ni-Ti instruments Root canal preparation will be done with theWaveOne System with strict adherence to the manufacturer's instructions. After coronal preflaring with File ISO 21 taper 8% instrument with 2.5% sodium hypochlorite as the irrigant, working length was determined and a glide path will created. The Red file R 25 taper 8% will be used for preparing the mesial canal; and the Black ISO 40 taper 8% file will be used for preparing the distal canals where there is only a single canal. |
| OneShape | Experimental | Other: One-shape rotationary systemOneShape (MICRO-MEGA) rotary nickel-titanium use roation movement and available in two sizes N°30 - .06 rotary files. , N°25 - .06 |
Who may qualify
- Ages
- 25 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Medically free patients
- Patient's age between 25-50 years.
- Mandibular molars diagnosed clinically as necrotic with normal apical tissues.
- Positive patient's acceptance for participation in the study.
- Both genders are included.
Key exclusion criteria (9 listed)
- Patients with complicating systemic disease.
- Having severe pain and/or acute apical abscesses.
- Under the age of 25 years.
- Patients using antibiotics or analgesic 12 hours before the procedures.
- Having multiple teeth that required treatment.
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 |
|---|---|---|
| One-shape rotationary systemOneShape (MICRO-MEGA) rotary nickel-titanium use roation movement and available in two sizes N°30 - .06 rotary files. , N°25 - .06 | Other | OneShape, wave -one reciprocating system |
Primary outcome
Post operative pain
Time frame: changes after 6 hours , 24 hours , 48 hours , 7 days The patient will be trained that 0 is no pain, 10 is the worst pain that interfere with his daily routine, and he will be asked to estimate the pain from 0 to 10
Post operative pain after mechanical preparation with wave one and one shape using VAS scale from 0 to 10 Post-operative pain is defined as any degree of pain that occurs after initiation of root canal treatment, while flare up is defined as the development or continuation of pain and/or swelling after endodontic treatment. The will be asked to record the level of pain at 6 hours, 24 hours, 48 hours and 7days after obturation. The patient will be trained that 0 is no pain, 10 is the worst pain that interfere with his daily routine, and he will be asked to estimate the pain as follows: 0 No pain. From 1-3 mild pain. From 4-5 moderate pain. From 7-10 severe pain
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Dec 2017.
- Individual participant dataSharing planned: Undecided
Related trials for Necrotic Pulp
Not yet recruiting
Post-operative Pain and Clinical Outcome After Single-cone Obturation With a Calcium Silicate-based Versus Epoxy Resin Sealer
Post Operative Pain, Acute, Irreversible Pulpitis (Toothache)
Not yet recruiting
PRP-Assisted Regenerative Endodontics Versus Conventional Root Canal Treatment in Mature Necrotic Teeth
Pulp Necrosis, Apical Periodontitis
Not yet recruiting
Influence of Continuous Rotation Versus Reciprocation Motion of MG3 Blue Rotary File on Postoperative Pain and Intracanal Bacterial Reduction of Teeth With Necrotic Pulps.
Necrotic Pulps With no Apical Periodontitis
Not yet recruiting
Clinical and Inflammatory Outcomes of Regenerative Endodontic Treatment Using Injectable Platelet-Rich Fibrin in Mature Necrotic Teeth With Chronic Apical Periodontitis.
Chronic Apical Periodontitis, Pulp Necrosis
Recruiting
Conventional and Nano-Metronidazole Irrigation With/Without Activation in Necrotic Teeth With Apical Periodontitis
Pulp Necrosis, 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.
Questions about this trial
What is this clinical trial studying?
A study testing One-shape rotationary system in people with Necrotic Pulp, 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 8 inclusion and 9 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 5 Dec 2017. 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 ahhmed Ragab (01005674370, ahmed-ragab@dentistry.cu.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Post operative pain (time frame: changes after 6 hours , 24 hours , 48 hours , 7 days The patient will be trained that 0 is no pain, 10 is the worst pain that interfere with his daily routine, and he will be asked to estimate the pain from 0 to 10). 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 5 Dec 2017.