Effect of Piezo-surgical Implant With Laser on Pain and Swelling in Patients With Missing TeethNCT04998292
Piezo-surgical Implant With Laser
A study testing Piezo-surgery with low level laser therapy and Piezo-surgery only in people with Effect of Piezo-surgical Implant With Laser on Pain and Swelling in Patients With Missing Teeth, run by Cairo University at 1 site in Egypt.
Trial summary
Evaluation of the effect of laser with piezo-surgical device in dental implants Read more about this study
- Who is it for?
- Ages 18 to 49 yearsHealthy volunteers can take part
- Conditions the study is for
- Effect of Piezo-surgical Implant With Laser on Pain and Swelling in Patients With Missing Teeth
- What is being tested?
- Piezo-surgery with low level laser therapy and Piezo-surgery only
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteEgypt
- Study dates
- 21 Jul 2021to 17 Aug 2021
- 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 49 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy subjects having good oral hygiene
- History of bilateral extractions in the lower molar area not less than 6 months ago.
Who cannot join
- Patients with debilitating diseases or bad oral hygiene,
- Patients with parafunctional habits and patients who are taking analgesics or with alcohol abuse.
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Mahmoud
Cairo
Mahmoud Sedky, 01091783307, dr.mahmoud.sedky@gmail.com
About this study
Official title: Piezo-surgical Implant Placement With Laser
Evaluation of the effect of laser with piezo-surgical device in dental implants
- Conditions
- Effect of Piezo-surgical Implant With Laser on Pain and Swelling in Patients With Missing Teeth
- Being tested
- Piezo-surgery with low level laser therapy, Piezo-surgery only
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Piezo-surgery with low level laser therapyDevice
Low level laser therapy
Piezo-surgery onlyDevice
Piezo-surgery only
| Study group | Role | What they receive |
|---|---|---|
| Low level laser therapy | Experimental | Not described Receives: Device: Piezo-surgery with low level laser therapy |
| Control | Active comparator | Not described Receives: Device: Piezo-surgery only |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assessment of pain
Measured: 2 hours after surgery
Assessment of pain using visual analog scale
Measured: 6 hours after surgery
Assessment of pain using visual analog scale
Measured: 24 hours after surgery
Assessment of pain using visual analog scale
Measured: 2 days after surgery
Assessment of pain using visual analog scale
Measured: 3 days after surgery
Assessment of pain using visual analog scale
Measured: 4 days after surgery
Assessment of pain using visual analog scale
Measured: 7 days after surgery
Secondary outcomes (7)
Swelling using swelling score system
Measured: 2 hours after surgery
Swelling using swelling score system
Measured: 6 hours after surgery
Swelling using swelling score system
Measured: 24 hours after surgery
Swelling using swelling score system
Measured: 2 days after surgery
Swelling
Measured: 3 days after surgery
Swelling using swelling score system
Measured: 4 days after surgery
Swelling using swelling score system
Measured: 7 days after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Aug 2021
- Study start21 Jul 2021
- Primary completion15 Aug 2021 (estimated)
- Study completion17 Aug 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Effect of Piezo-surgical Implant With Laser on Pain and Swelling in Patients With Missing TeethStudies 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
- Model description
- split mouth study
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mahmoud Sedky, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04998292
- Sponsor's protocol ID
- REC/82-2021
- Status last verified
- Aug 2021
- First submitted
- 19 Jul 2021
- Last updated
- 10 Aug 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Piezo-surgical Implant Placement With Laser
- ClinicalTrials.gov ID
- NCT04998292
- Acronym / sponsor ID
- REC/82-2021
- Conditions
- Effect of Piezo-surgical Implant With Laser on Pain and Swelling in Patients With Missing Teeth
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 21 Jul 2021 (actual)
- Primary completion
- 15 Aug 2021 (estimated)
- Study completion
- 17 Aug 2021 (estimated)
- First posted
- 10 Aug 2021 (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.
Evaluation of the effect of laser with piezo-surgical device in dental implants
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- split mouth study
| Arm | Type | Receives |
|---|---|---|
| Low level laser therapy | Experimental | Device: Piezo-surgery with low level laser therapy |
| Control | Active comparator | Device: Piezo-surgery only |
Who may qualify
- Ages
- 18 to 49 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Healthy subjects having good oral hygiene
- History of bilateral extractions in the lower molar area not less than 6 months ago.
Key exclusion criteria (2 listed)
- Patients with debilitating diseases or bad oral hygiene,
- Patients with parafunctional habits and patients who are taking analgesics or with alcohol abuse.
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 |
|---|---|---|
| Piezo-surgery with low level laser therapyLow level laser therapy | Device | Low level laser therapy |
| Piezo-surgery onlyPiezo-surgery only | Device | Control |
Primary outcome
Assessment of pain
Time frame: 2 hours after surgery
Assessment of pain using visual analog scale
Time frame: 6 hours after surgery
Assessment of pain using visual analog scale
Time frame: 24 hours after surgery
Assessment of pain using visual analog scale
Time frame: 2 days after surgery
Assessment of pain using visual analog scale
Time frame: 3 days after surgery
Assessment of pain using visual analog scale
Time frame: 4 days after surgery
Assessment of pain using visual analog scale
Time frame: 7 days after surgery
7 secondary outcomes
Swelling using swelling score system
Time frame: 2 hours after surgery
Swelling using swelling score system
Time frame: 6 hours after surgery
Swelling using swelling score system
Time frame: 24 hours after surgery
Swelling using swelling score system
Time frame: 2 days after surgery
Swelling
Time frame: 3 days after surgery
Swelling using swelling score system
Time frame: 4 days after surgery
Swelling using swelling score system
Time frame: 7 days after surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Aug 2021.
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Piezo-surgery with low level laser therapy and Piezo-surgery only in people with Effect of Piezo-surgical Implant With Laser on Pain and Swelling in Patients With Missing Teeth, run by Cairo 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 2 inclusion and 2 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 10 Aug 2021. 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. 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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Assessment of pain (time frame: 2 hours after surgery). The study lists 7 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 10 Aug 2021.