Apical PeriodontitisNCT02929511
Reciprocation vs Rotational Single-file Systems in Postoperative Pain
A study testing Reciprocating single-file system, Rotational single-file system. and Active comparator Protaper multi-file system in people with Apical Periodontitis and Assessment, Pain, run by Isparta Military Hospital at 1 site in Turkey (Türkiye).
Trial summary
In this study, the researchers will investigate the effect of single-file reciprocating versus single-file rotational file systems on the postoperative pain in adult patients who have necrotic pulp and apical periodontitis. Read more about this study
- Who is it for?
- Ages 21 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Apical Periodontitis, Assessment, Pain, Dental Pulp Necrosis
- What is being tested?
- Reciprocating single-file system, Rotational single-file system. and Active comparator Protaper multi-file system
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 91 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jan 2017to 18 Apr 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 21 to 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Participants who have in their mandibular or maxillary molar teeth necrotic pulp and apical periodontitis.
Who cannot join
- Pregnancy, drug hypersensitivity, cardiac problems, previously performed endodontics treatment.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Influence of Reciprocating and Rotational Single-file Systems on the Postoperative Pain: A Randomized Clinical Trial.
In this study, the researchers will investigate the effect of single-file reciprocating versus single-file rotational file systems on the postoperative pain in adult patients who have necrotic pulp and apical periodontitis. The participants will be assigned by chance to separate groups that compare 2 different treatments, reciprocating single-file system (Reciproc Blue) and rotational single-file system (OneShape). As a reference, Mtwo multi-file (full-sequence) will be used.
Read the detailed description
The infected root canal treatments will be performed using one-visit approach with either a reciprocating single-file system or a continuous rotational single-file system. (Reciproc Blue reciprocating single-file system vs OneShape rotational single-file system). The root canals will be completed in single-visit. The patients will record their postoperative pain during the follow-up period using a VAS scale.
- Conditions
- Apical Periodontitis, Assessment, Pain, Dental Pulp Necrosis
- Being tested
- Reciprocating single-file system, Rotational single-file system., Active comparator Protaper multi-file system
- Medical subject headings
- Periapical Periodontitis, Pain, Dental Pulp Necrosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Reciprocating single-file systemProcedure or surgery
Also called Reciproc Blue
The device is moving in CW and CCW direction with different angles. It is a single-file endodontic file. The intervention is Reciproc Blue reciprocating single-file system.
Rotational single-file system.Procedure or surgery
Also called OneShape
The device is moving in continuous rotational. It is a single-fie endodontic file.
Active comparator Protaper multi-file systemProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| Reciproc Blue | Experimental | Endodontic treatment will be performed in teeth with necrotic pulp and periapical periodontitis. Local anaesthesia will be provided (2% Novocaine with 1:80,000 epinephrine), isolation with rubber dam and standard access cavity preparation will be done.Using 2.5 % sodium hypochlorite, canal negotiation will be done. Coronal flaring with # 2 and #3 Gates-Glidden drills will be done. The canals will be obturated with gutta-percha and epoxy resin sealer. The treatments will be carried out in single-visit. In this group, intervention will be carried out by the Reciproc motor (VDW, Germany) and Reciproc Blue single-file system (VDW, Germany). The intervention is root canal treatment with the Reciproc Blue single-file system. Receives: Procedure: Reciprocating single-file system |
| OneShape | Experimental | In this group, OneShape rotational single-file system (Micro Mega, France) will be used as single-file system according to the manufacturer's instruction. Receives: Procedure: Rotational single-file system. |
| Protaper | Active comparator | As a control group, Protaper (Dentsply, Mailleffer, Switzerland) will be used according to the manufacturer's instruction. Receives: Procedure: Active comparator Protaper multi-file system |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain level
A VAS scale will be used for the postoperative pain level. The patients will noted their postoperative pain level according to the VAS scale during the follow-up period.
Measured: 7 days.
Secondary outcomes (1)
Analgesic usage
The patients will record the consumption of the analgesic during the 7 days of follow-up.
Measured: 7 days.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Oct 2016 (estimated)
- Study start1 Jan 2017
- Primary completion1 Apr 2018
- Study completion18 Apr 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Apical PeriodontitisStudies of the same condition, open and under way.
- 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
- 91 participants (actual)
Sponsor and investigators
- Lead sponsor
- Isparta Military Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ibrahim E YAYLALI, PhD, Principal investigator, Devlet hastanesi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02929511
- Sponsor's protocol ID
- IAH-3
- Status last verified
- Mar 2017
- First submitted
- 7 Oct 2016
- Last updated
- 23 Apr 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 23 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Influence of Reciprocating and Rotational Single-file Systems on the Postoperative Pain: A Randomized Clinical Trial.
- ClinicalTrials.gov ID
- NCT02929511
- Acronym / sponsor ID
- IAH-3
- Conditions
- Apical Periodontitis, Assessment, Pain, Dental Pulp Necrosis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 91 participants (actual)
- Lead sponsor
- Isparta Military HospitalUniversity, hospital or other
- Study start
- 1 Jan 2017 (actual)
- Primary completion
- 1 Apr 2018 (actual)
- Study completion
- 18 Apr 2018 (actual)
- First posted
- 11 Oct 2016 (estimated)
- 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.
In this study, the researchers will investigate the effect of single-file reciprocating versus single-file rotational file systems on the postoperative pain in adult patients who have necrotic pulp and apical periodontitis. The participants will be assigned by chance to separate groups that compare 2 different treatments, reciprocating single-file system (Reciproc Blue) and rotational single-file system (OneShape). As a reference, Mtwo multi-file (full-sequence) will be used.
Detailed description
The infected root canal treatments will be performed using one-visit approach with either a reciprocating single-file system or a continuous rotational single-file system. (Reciproc Blue reciprocating single-file system vs OneShape rotational single-file system). The root canals will be completed in single-visit. The patients will record their postoperative pain during the follow-up period using a VAS scale.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Reciproc Blue | Experimental | Procedure: Reciprocating single-file systemEndodontic treatment will be performed in teeth with necrotic pulp and periapical periodontitis. Local anaesthesia will be provided (2% Novocaine with 1:80,000 epinephrine), isolation with rubber dam and standard access cavity preparation will be done.Using 2.5 % sodium hypochlorite, canal negotiation will be done. Coronal flaring with # 2 and #3 Gates-Glidden drills will be done. The canals will be obturated with gutta-percha and epoxy resin sealer. The treatments will be carried out in single-visit. In this group, intervention will be carried out by the Reciproc motor (VDW, Germany) and Reciproc Blue single-file system (VDW, Germany). The intervention is root canal treatment with the Reciproc Blue single-file system. |
| OneShape | Experimental | Procedure: Rotational single-file system.In this group, OneShape rotational single-file system (Micro Mega, France) will be used as single-file system according to the manufacturer's instruction. |
| Protaper | Active comparator | Procedure: Active comparator Protaper multi-file systemAs a control group, Protaper (Dentsply, Mailleffer, Switzerland) will be used according to the manufacturer's instruction. |
Who may qualify
- Ages
- 21 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Participants who have in their mandibular or maxillary molar teeth necrotic pulp and apical periodontitis.
Key exclusion criteria (1 listed)
- Pregnancy, drug hypersensitivity, cardiac problems, previously performed endodontics 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 |
|---|---|---|
| Reciprocating single-file systemAlso: Reciproc BlueThe device is moving in CW and CCW direction with different angles. It is a single-file endodontic file. The intervention is Reciproc Blue reciprocating single-file system. | Procedure or surgery | Reciproc Blue |
| Rotational single-file system.Also: OneShapeThe device is moving in continuous rotational. It is a single-fie endodontic file. | Procedure or surgery | OneShape |
| Active comparator Protaper multi-file system | Procedure or surgery | Protaper |
Primary outcome
Pain level
Time frame: 7 days.
A VAS scale will be used for the postoperative pain level. The patients will noted their postoperative pain level according to the VAS scale during the follow-up period.
1 secondary outcome
Analgesic usage
Time frame: 7 days.
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 23 Apr 2018.
- Individual participant dataSharing planned: Yes
Related trials for Apical Periodontitis
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Symptomatic Irreversible Pulpitis, Symptomatic Apical Periodontitis
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Effects of Different Activation Techniques on Antimicrobial Photodynamic Therapy in Apical Periodontitis
Apical Periodontitis, Endodontic Retreatment
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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)
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PRP-Assisted Regenerative Endodontics Versus Conventional Root Canal Treatment in Mature Necrotic Teeth
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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
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.
Ibrahim E YAYLALI, PhD principal investigator
Devlet hastanesi
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Reciprocating single-file system, Rotational single-file system. and Active comparator Protaper multi-file system in people with Apical Periodontitis and Assessment, Pain, run by Isparta Military Hospital at 1 site in Turkey (Türkiye).
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 1 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 23 Apr 2018. 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 Turkey (Türkiye). 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?
Pain level (time frame: 7 days.). 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 23 Apr 2018.