Periapical DiseasesNCT04311879
Efficiency of Soft Tissue Diode Laser Application on Healing of Periapical Tissues
A study testing Soft tissue Diode laser application in people with Periapical Diseases, run by Ain Shams University at 1 site in Egypt.
Trial summary
Study is a Randomized clinical trial conducted at Endodontic department- Ain Shams university Cairo. Egypt. 24 eligible patients were selected and included in the study to compare healing ability of soft tissue diode laser application versus conventional root canal treatment using CBCT Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Periapical Diseases
- What is being tested?
- Soft tissue Diode laser application
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 24 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jul 2017to 1 Jan 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 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Adult patients age between 18-50 years
- Medically free patients.
- Patients suffering from acute or chronic infection with symptomatic apical periodontitis with Necrotic pulp
- Preoperative Pain
- Sensitivity to percussion
- Periapical radiographic X-ray showing periapical lesion with no gutta percha in canal
- Occlusal contact with opposing teeth
Who cannot join
- Pregnant females.
- Patients having a significant systemic disorder or history of drug abuse
- Patients who had administrated analgesics or antibiotics during the last 12 hours preoperatively.
- Patients having bruxism or clenching
- Teeth having:
- No occlusal contact
Show all 13Show fewer
- No sensitivity to percussion
- Greater than grade I mobility.
- Pocket depth greater than 5mm.
- No possible restorability
- Procedural errors
- Previous Root canal treatment
- Open apex
Trial locations and contacts
1 site in 1 country.
Egypt1 site
Endodontic department - Faculty of Dentistry Ainshams University
Cairo
About this study
Official title: Efficiency of Soft Tissue Diode Laser Application on Healing of Periapical Tissues (A Randomized Clinical Trial)
Study is a Randomized clinical trial conducted at Endodontic department- Ain Shams university Cairo. Egypt. 24 eligible patients were selected and included in the study to compare healing ability of soft tissue diode laser application versus conventional root canal treatment using CBCT
Read the detailed description
Sample size is 24 24 Patients were randomly distributed in 2 groups , one group of patients received soft tissue laser therapy after root canal treatment and the other group received no treatment just conventional RCT. • Patients were equally divided into 2 groups (n=12 in each group ) The study in a Single blinded RCT , Numbers for patients will be generated and distributed randomly in a table on an Excel sheet, and in front of each number either a letter (C) for control or (I) for intervention will be typed After patients were selected in the study they will be asked to fill in a consent form , that states that they are part of a clinical trial and that they may or may not have a laser session following root canal treatment Group A Soft tissue laser application : Endodontically treated teeth were targeted by virtue of a dental applicator positioned at a right angle to the mucosa at the level of the apices. Application of the laser probe were applied to both the buccal and lingual mucosae overlying the apices of the target tooth. Total exposure time for each tooth was 60 seconds (a dose = 70 j/cm2 for analgesia) by the co-investigator The laser unit used in this study will be a diode laser (Lite Medics 1.00 Watt serial number 148 Ver.SwvM. 150VS108VT.100) of wavelength 980nm and Max power 15 WCW Class IV Laser Product ) in continuous wave mode Group B : Placebo : conventional root canal treatment : mock laser intervention A CBCT was taken preoperative and after 12 month postoperative, both linear and volumetric measurements were calculated
- Conditions
- Periapical Diseases
- Being tested
- Soft tissue Diode laser application, Placebo
- Keywords
- Diode laser, low level laser therapy, CBCT
- Medical subject headings
- Periapical Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Soft tissue Diode laser applicationDevice
Also called Low laser therapy
post-operative soft tissue diode laser application
PlaceboOther
mock diode laser application
| Study group | Role | What they receive |
|---|---|---|
| Soft tissue laser Diode laser application | Experimental | Endodontically treated teeth by virtue of a dental applicator positioned at a right angle to the mucosa at the level of the apices. Application of the laser probe was applied to both the buccal and lingual mucosae overlying the apices of the target tooth. Total exposure time for each tooth was 60 seconds (a dose = 70 j/cm2 for analgesia) The laser unit used in this study used was a diode laser (Lite Medics 1.00Watt serial number 148 Ver.SwvM. 150VS108VT.100) of wavelength 980nm and Max power 15WCW Class IV Laser Product Receives: Device: Soft tissue Diode laser application |
| conventional root canal treatment | Placebo comparator | Placebo : conventional root canal conventional root canal treatment with irrigation of sodium hypochlorite 2.5% with mock laser intervention Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assess post-operative healing in a period of 12 month when using Soft tissue diode laser application post-operative using CBCT
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Mar 2020
- Study start1 Jul 2017
- Primary completion1 Jul 2019
- Study completion1 Jan 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Periapical DiseasesStudies of the same condition, open and under way.
- More trials run by Ain Shams 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
- Participant
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hend Hamdy Ismail, Ain Shams University
- Investigators
- Maram Obeid, PhD, Study director, AinShams UniversityEhab Hassanien, PhD, Study chair, Ainshams University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04311879
- Sponsor's protocol ID
- END 16-14D
- Status last verified
- Mar 2020
- First submitted
- 7 Mar 2020
- Last updated
- 18 Mar 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficiency of Soft Tissue Diode Laser Application on Healing of Periapical Tissues (A Randomized Clinical Trial)
- ClinicalTrials.gov ID
- NCT04311879
- Acronym / sponsor ID
- END 16-14D
- Conditions
- Periapical Diseases
- Keywords
- Diode laser, low level laser therapy, CBCT
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- 1 Jul 2017 (actual)
- Primary completion
- 1 Jul 2019 (actual)
- Study completion
- 1 Jan 2020 (actual)
- First posted
- 17 Mar 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.
Study is a Randomized clinical trial conducted at Endodontic department- Ain Shams university Cairo. Egypt. 24 eligible patients were selected and included in the study to compare healing ability of soft tissue diode laser application versus conventional root canal treatment using CBCT
Detailed description
Sample size is 24 24 Patients were randomly distributed in 2 groups , one group of patients received soft tissue laser therapy after root canal treatment and the other group received no treatment just conventional RCT. • Patients were equally divided into 2 groups (n=12 in each group ) The study in a Single blinded RCT , Numbers for patients will be generated and distributed randomly in a table on an Excel sheet, and in front of each number either a letter (C) for control or (I) for intervention will be typed After patients were selected in the study they will be asked to fill in a consent form , that states that they are part of a clinical trial and that they may or may not have a laser session following root canal treatment Group A Soft tissue laser application : Endodontically treated teeth were targeted by virtue of a dental applicator positioned at a right angle to the mucosa at the level of the apices. Application of the laser probe were applied to both the buccal and lingual mucosae overlying the apices of the target tooth. Total exposure time for each tooth was 60 seconds (a dose = 70 j/cm2 for analgesia) by the co-investigator The laser unit used in this study will be a diode laser (Lite Medics 1.00 Watt serial number 148 Ver.SwvM. 150VS108VT.100) of wavelength 980nm and Max power 15 WCW Class IV Laser Product ) in continuous wave mode Group B : Placebo : conventional root canal treatment : mock laser intervention A CBCT was taken preoperative and after 12 month postoperative, both linear and volumetric measurements were calculated
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Soft tissue laser Diode laser application | Experimental | Device: Soft tissue Diode laser applicationEndodontically treated teeth by virtue of a dental applicator positioned at a right angle to the mucosa at the level of the apices. Application of the laser probe was applied to both the buccal and lingual mucosae overlying the apices of the target tooth. Total exposure time for each tooth was 60 seconds (a dose = 70 j/cm2 for analgesia) The laser unit used in this study used was a diode laser (Lite Medics 1.00Watt serial number 148 Ver.SwvM. 150VS108VT.100) of wavelength 980nm and Max power 15WCW Class IV Laser Product |
| conventional root canal treatment | Placebo comparator | Other: PlaceboPlacebo : conventional root canal conventional root canal treatment with irrigation of sodium hypochlorite 2.5% with mock laser intervention |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Adult patients age between 18-50 years
- Medically free patients.
- Patients suffering from acute or chronic infection with symptomatic apical periodontitis with Necrotic pulp
- Preoperative Pain
- Sensitivity to percussion
Key exclusion criteria (13 listed)
- Pregnant females.
- Patients having a significant systemic disorder or history of drug abuse
- Patients who had administrated analgesics or antibiotics during the last 12 hours preoperatively.
- Patients having bruxism or clenching
- Teeth having:
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 |
|---|---|---|
| Soft tissue Diode laser applicationAlso: Low laser therapypost-operative soft tissue diode laser application | Device | Soft tissue laser Diode laser application |
| Placebomock diode laser application | Other | conventional root canal treatment |
Primary outcome
Assess post-operative healing in a period of 12 month when using Soft tissue diode laser application post-operative using CBCT
Time frame: 12 months
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 18 Mar 2020.
- Individual participant dataSharing planned: No
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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.
Maram Obeid, PhD study director
AinShams University
Ehab Hassanien, PhD study chair
Ainshams University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Soft tissue Diode laser application in people with Periapical Diseases, run by Ain Shams University at 1 site in Egypt.
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 7 inclusion and 13 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 18 Mar 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 Egypt. 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. Some participants in this study may receive a placebo. 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?
Assess post-operative healing in a period of 12 month when using Soft tissue diode laser application post-operative using CBCT (time frame: 12 months). 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 18 Mar 2020.