PeriodontitisNCT04628845
Endo-perio Lesion's Treatment With Using Diode Laser 940nm
A study testing Endo-perio therapy with laser 940nm and Endo-perio therapy without laser 940nm in people with Periodontitis and Endodontic Inflammation, run by Pomeranian Medical University Szczecin at 3 sites in Poland.
Trial summary
Periodontal marginal and periapical diseases cause a huge destruction of tissues surrounding the tooth with periodontal patients. Treatment consists on elimination of pathogens, which are presented in periodontal pockets and also in root canals. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Periodontitis, Endodontic Inflammation
- What is being tested?
- Endo-perio therapy with laser 940nm and Endo-perio therapy without laser 940nm
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 20 participants
- Where
- 3 sitesPoland
- Study dates
- 31 Aug 2019to 31 Aug 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- advanced periodontitis stage III, with endo-periodontal lesion without root damage,
- presence of at least 20 teeth,
- at least one molar tooth in each quadrant with a minimum of four teeth.
Who cannot join
- -systemic illnesses (unbalanced diabetes mellitus, immunosuppressive drug or HIV), -
- pregnancy or lactation,
- smoking or alcoholism.
Trial locations and contacts
3 sites in 1 country.
Poland3 sites, 3 recruiting
- Recruiting
Pomeranian Medical University
Szczecin, West Pomeranian Voivodeship, 70-200
- Recruiting
Pomeranian Medical University
Szczecin, West Pomeranian Voivodeship, 70-200
Elżbieta Dembowska, Prof, e.dembowska@vp.pl
- Recruiting
Pomeranian Medical University
Szczecin, West Pomeranian Voivodeship, 70-200
Elżbieta Dembowska, Prof, e.dembowska@pum.edu.pl
About this study
Official title: Evaluation of Endo-perio Lesion's Treatment Using Additional Diode Laser 940nm.
Periodontal marginal and periapical diseases cause a huge destruction of tissues surrounding the tooth with periodontal patients. Treatment consists on elimination of pathogens, which are presented in periodontal pockets and also in root canals. To increase efficiency of endo-perio treatment there is used diode laser wavelength 940nm. Laser disinfection is done in periodontal pockets and root canals.
The aim of the study is to evaluate the effectiveness of treatment of endo-perio lesions with use of medicaments and diode laser.
The study will present cases of endo-perio lesions around molars in investigated and control group. Teeth were subjected to endodontic and periodontological treatment. The roots and pockets have been disinfected with a diode laser only in investigated group. In the both groups between the visits into root canals there were applied alkaline paste. The treatment was completed after 6 months. Before the beginning and after the end of treatment there were made a two-dimensional image and CBCT. CBCT was subjected to manual segmentation. The resulting streolitographic models were allowed to check the change of bone volume.
Read the detailed description
This study will presented the cases of two groups of patients, in which the endo-perio lesions were reported. The study protocol was approved by the Institutional Ethics Commission of Pomeranian University (No: KB-0012/29/17). Each subject provided informed consent after explanation of the protocol, risk and benefits of study.The both groups counted the same amount of molar teeth - ten molars in investigated (n=10) and in control group (n=10). In the study there were 9 men and 11 women aged between 35 and 58 years.
The study was performed according to split-teeth design, computerized randomly allocated to the control or the investigated group. At first group (investigated group) there were implemented periodontal and endodontic treatment with additional using diode laser wavelength 940 nm. The same steps were made in control group, however without using diode laser in medical procedures.
The first step was to do the clinical measurements (PD,CAL, tooth mobility, vitality test, occlusal condition) and analysis of pantomographic picture, the patients were diagnosed with third grade periodontitis The depth of periodontal pockets (PD) were checked by using manual periodontal probe (UNC 15, Hu-Friedy) on six sites. The classified teeth, which were diagnosed perio-endo lesions, were showed any vitality during testing faradic and ethyl chloride. The teeth did not respond properly. Also the tested teeth were checked with using Periotest M (Medizintechnik Gulden) in both groups before and after the treatment.
Every enrolled patients were checked by using the T-scan Novus (Tekscan). T-scan system records patients bite force, dynamics, including occlusal force, location and timing.
The treatment in EPL should be carried out in two ways- periodontal and endodontic. One of these ways there is mechanical non-surgical treatment of periodontium and endodontic way is eliminated the bacteria, which inside in root canals.
- Conditions
- Periodontitis, Endodontic Inflammation
- Being tested
- Endo-perio therapy with laser 940nm, Endo-perio therapy without laser 940nm
- Keywords
- EPL, periodontitis, laser, CBCT
- Medical subject headings
- Periodontitis, Pulpitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Endo-perio therapy with laser 940nmDevice
Periodontal pockets's treatment of scaling, root debridement and endodontic treatment of root canals with using laser 940nm.
Endo-perio therapy without laser 940nmDevice
Periodontal pockets's treatment of scaling, root debridement and endodontic treatment of root canals
| Study group | Role | What they receive |
|---|---|---|
| SRP and endontic treatment without laser 940nm | Placebo comparator | Periodontal pockets's treatment of scaling, root debridement and endodontic treatment of root canals without using laser 940nm. Receives: Device: Endo-perio therapy without laser 940nm |
| SRP and endodontic treatment with laser 940nm | Active comparator | Periodontal pockets's treatment of scaling, root debridement and endodontic treatment of root canals with using laser 940nm. Receives: Device: Endo-perio therapy with laser 940nm |
What is being measured
The primary outcome is the main question the study is designed to answer.
PD
periodontal pocket depht
Measured: up to 3 months
Mobility Tooth
checking mobility with using Periotest
Measured: up to 6 months
CBCT and STL
Cone Bean Computed Tomography, stereolithographic models
Measured: up to 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Nov 2020
- Study start31 Aug 2019
- Primary completion31 Dec 2021 (estimated)
- Study completion31 Aug 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- Triple blind
- Who is masked
- Care provider, Investigator, Outcomes assessor
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Pomeranian Medical University Szczecin
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Elżbieta Dembowska, Pomeranian Medical University Szczecin
- Investigators
- Aleksandra Homik-Rodzińska, Msc, Study director, lek.dent. Aleksandra Homik-Rodzińska
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04628845
- Sponsor's protocol ID
- Interventional
- Status last verified
- Nov 2020
- First submitted
- 9 Nov 2020
- Last updated
- 16 Nov 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Documentation of study participants in paper form will be kept at the Department of Periodontology. We provide information on aggregate results in tables and statistical analysis after contact by email.
Study at a glance
From the registry record, last updated by the sponsor on 16 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Endo-perio Lesion's Treatment Using Additional Diode Laser 940nm.
- ClinicalTrials.gov ID
- NCT04628845
- Acronym / sponsor ID
- Interventional
- Conditions
- Periodontitis, Endodontic Inflammation
- Keywords
- EPL, periodontitis, laser, CBCT
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Pomeranian Medical University SzczecinUniversity, hospital or other
- Study start
- 31 Aug 2019 (actual)
- Primary completion
- 31 Dec 2021 (estimated)
- Study completion
- 31 Aug 2022 (estimated)
- First posted
- 16 Nov 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.
Periodontal marginal and periapical diseases cause a huge destruction of tissues surrounding the tooth with periodontal patients. Treatment consists on elimination of pathogens, which are presented in periodontal pockets and also in root canals. To increase efficiency of endo-perio treatment there is used diode laser wavelength 940nm. Laser disinfection is done in periodontal pockets and root canals.
The aim of the study is to evaluate the effectiveness of treatment of endo-perio lesions with use of medicaments and diode laser.
The study will present cases of endo-perio lesions around molars in investigated and control group. Teeth were subjected to endodontic and periodontological treatment. The roots and pockets have been disinfected with a diode laser only in investigated group. In the both groups between the visits into root canals there were applied alkaline paste. The treatment was completed after 6 months. Before the beginning and after the end of treatment there were made a two-dimensional image and CBCT. CBCT was subjected to manual segmentation. The resulting streolitographic models were allowed to check the change of bone volume.
Detailed description
This study will presented the cases of two groups of patients, in which the endo-perio lesions were reported. The study protocol was approved by the Institutional Ethics Commission of Pomeranian University (No: KB-0012/29/17). Each subject provided informed consent after explanation of the protocol, risk and benefits of study.The both groups counted the same amount of molar teeth - ten molars in investigated (n=10) and in control group (n=10). In the study there were 9 men and 11 women aged between 35 and 58 years.
The study was performed according to split-teeth design, computerized randomly allocated to the control or the investigated group. At first group (investigated group) there were implemented periodontal and endodontic treatment with additional using diode laser wavelength 940 nm. The same steps were made in control group, however without using diode laser in medical procedures.
The first step was to do the clinical measurements (PD,CAL, tooth mobility, vitality test, occlusal condition) and analysis of pantomographic picture, the patients were diagnosed with third grade periodontitis The depth of periodontal pockets (PD) were checked by using manual periodontal probe (UNC 15, Hu-Friedy) on six sites. The classified teeth, which were diagnosed perio-endo lesions, were showed any vitality during testing faradic and ethyl chloride. The teeth did not respond properly. Also the tested teeth were checked with using Periotest M (Medizintechnik Gulden) in both groups before and after the treatment.
Every enrolled patients were checked by using the T-scan Novus (Tekscan). T-scan system records patients bite force, dynamics, including occlusal force, location and timing.
The treatment in EPL should be carried out in two ways- periodontal and endodontic. One of these ways there is mechanical non-surgical treatment of periodontium and endodontic way is eliminated the bacteria, which inside in root canals.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| SRP and endontic treatment without laser 940nm | Placebo comparator | Device: Endo-perio therapy without laser 940nmPeriodontal pockets's treatment of scaling, root debridement and endodontic treatment of root canals without using laser 940nm. |
| SRP and endodontic treatment with laser 940nm | Active comparator | Device: Endo-perio therapy with laser 940nmPeriodontal pockets's treatment of scaling, root debridement and endodontic treatment of root canals with using laser 940nm. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- advanced periodontitis stage III, with endo-periodontal lesion without root damage,
- presence of at least 20 teeth,
- at least one molar tooth in each quadrant with a minimum of four teeth.
Key exclusion criteria (3 listed)
- -systemic illnesses (unbalanced diabetes mellitus, immunosuppressive drug or HIV), -
- pregnancy or lactation,
- smoking or alcoholism.
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 |
|---|---|---|
| Endo-perio therapy with laser 940nmPeriodontal pockets's treatment of scaling, root debridement and endodontic treatment of root canals with using laser 940nm. | Device | SRP and endodontic treatment with laser 940nm |
| Endo-perio therapy without laser 940nmPeriodontal pockets's treatment of scaling, root debridement and endodontic treatment of root canals | Device | SRP and endontic treatment without laser 940nm |
Primary outcome
PD
Time frame: up to 3 months
periodontal pocket depht
Mobility Tooth
Time frame: up to 6 months
checking mobility with using Periotest
CBCT and STL
Time frame: up to 6 months
Cone Bean Computed Tomography, stereolithographic models
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Nov 2020.
- Individual participant dataSharing planned: No. Documentation of study participants in paper form will be kept at the Department of Periodontology. We provide information on aggregate results in tables and statistical analysis after contact by email.
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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.
Aleksandra Homik-Rodzińska, Msc study director
lek.dent. Aleksandra Homik-Rodzińska
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Endo-perio therapy with laser 940nm and Endo-perio therapy without laser 940nm in people with Periodontitis and Endodontic Inflammation, run by Pomeranian Medical University Szczecin at 3 sites in Poland.
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 3 inclusion and 3 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 16 Nov 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Poland. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Elżbieta Dembowska, Prof (48914661745, elzbieta.dembowska@pum.edu.pl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
PD (time frame: up to 3 months). The study lists 3 primary outcomes in all. 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 16 Nov 2020.