Anesthesia, LocalNCT05648981
Diode Laser on the Reversal of Inferior Alveolar Nerve Block Anesthesia in Children
A study testing Inferior Alveolar Nerve Block administration with laser irradiation and Inferior Alveolar Nerve Block administration in people with Anesthesia, Local, run by Hams Hamed Abdelrahman at 1 site in Egypt.
Trial summary
Inevitable problems were reported following the injection of local anesthesia in pediatric dental procedures, which can last until the elimination of soft tissue anesthesia. Purpose of the study: To evaluate the effectiveness of diode laser photobiomodulation therapy on the reversal of soft tissue anesthesia (STA) in… Read more about this study
- Who is it for?
- Ages 5 to 8 years
- Conditions the study is for
- Anesthesia, Local
- What is being tested?
- Inferior Alveolar Nerve Block administration with laser irradiation and Inferior Alveolar Nerve Block administration
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 1 siteEgypt
- Study dates
- 2 Nov 2022to 30 Dec 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 5 to 8 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Patients in need of operative dental procedures, requiring inferior alveolar nerve (IANB) anesthesia.
- Healthy patients (physical status ASA I).
- Definitely positive or positive patients on the Frankl behavior scale.
- No reported allergies to LA, epinephrine or sulfites.
- Normal lip sensation before administration of LA
Who cannot join
- Patients requiring surgical procedures (i.e. extractions).
- Patients who will show excessive fear to the Transcutaneous Electric Nerve Stimulator (TENS) device and provide a false-positive response on inactivated electrode (absence of current) using the Venham scale.
- Patients who will not be trainable in the standardized lip tapping procedure (could not learn to distinguish the anesthetized numb side from the non-anesthetized side).
- Patients who will not achieve profound numbness after initial LA administration, requiring additional anesthesia using SEM scale.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effectiveness of Photobiomodulation Using Diode Laser on the Reversal of Inferior Alveolar Nerve Block Anesthesia in Children: a Randomized Controlled Clinical Trial
Inevitable problems were reported following the injection of local anesthesia in pediatric dental procedures, which can last until the elimination of soft tissue anesthesia.
Purpose of the study: To evaluate the effectiveness of diode laser photobiomodulation therapy on the reversal of soft tissue anesthesia (STA) in children following inferior alveolar nerve block anesthesia.
- Conditions
- Anesthesia, Local
- Being tested
- Inferior Alveolar Nerve Block administration with laser irradiation, Inferior Alveolar Nerve Block administration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Inferior Alveolar Nerve Block administration with laser irradiationOther
Patients will receive inferior alveolar nerve block local anesthesia followed by laser irradiation after completion of the operative procedure.
Inferior Alveolar Nerve Block administrationOther
Patients will not receive any laser irradiation after administration of inferior alveolar nerve block local anesthesia.
| Study group | Role | What they receive |
|---|---|---|
| Test group | Experimental | Not described Receives: Other: Inferior Alveolar Nerve Block administration with laser irradiation |
| Control group | Active comparator | Not described Receives: Other: Inferior Alveolar Nerve Block administration |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to recovery of normal lip sensation
Patients will be asked to rate the lower lip numbness on the anesthetized side in comparison to the contralateral non-anesthetized side as described previously.
Patients" responses will be recorded every time as "yes" or "no". the number of minutes elapsed from exposure to laser irradiation to the first reported a normal sensation of the lower lip
Measured: For two hours after the procedure
Secondary outcomes (1)
Assessment of soft tissue injury
A telephone call will be done inquiring on any trauma, injury, swelling or biting marks on the lower lip after 24 h.
this will be recorded as Yes/no responses
Measured: 24 hours after the procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Dec 2022
- Study start2 Nov 2022
- Primary completion30 Dec 2022 (estimated)
- Study completion30 Dec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Anesthesia, LocalStudies 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 32 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hams Hamed Abdelrahman
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Hams Hamed Abdelrahman, Alexandria University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05648981
- Sponsor's protocol ID
- Anesthesia_2022
- Status last verified
- Dec 2022
- First submitted
- 1 Nov 2022
- Last updated
- 13 Dec 2022
- 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 13 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Photobiomodulation Using Diode Laser on the Reversal of Inferior Alveolar Nerve Block Anesthesia in Children: a Randomized Controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT05648981
- Acronym / sponsor ID
- Anesthesia_2022
- Conditions
- Anesthesia, Local
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 32 participants (estimated)
- Lead sponsor
- Hams Hamed AbdelrahmanUniversity, hospital or other
- Study start
- 2 Nov 2022 (actual)
- Primary completion
- 30 Dec 2022 (estimated)
- Study completion
- 30 Dec 2022 (estimated)
- First posted
- 13 Dec 2022 (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.
Inevitable problems were reported following the injection of local anesthesia in pediatric dental procedures, which can last until the elimination of soft tissue anesthesia.
Purpose of the study: To evaluate the effectiveness of diode laser photobiomodulation therapy on the reversal of soft tissue anesthesia (STA) in children following inferior alveolar nerve block anesthesia.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Test group | Experimental | Other: Inferior Alveolar Nerve Block administration with laser irradiation |
| Control group | Active comparator | Other: Inferior Alveolar Nerve Block administration |
Who may qualify
- Ages
- 5 to 8 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- Patients in need of operative dental procedures, requiring inferior alveolar nerve (IANB) anesthesia.
- Healthy patients (physical status ASA I).
- Definitely positive or positive patients on the Frankl behavior scale.
- No reported allergies to LA, epinephrine or sulfites.
- Normal lip sensation before administration of LA
Key exclusion criteria (4 listed)
- Patients requiring surgical procedures (i.e. extractions).
- Patients who will show excessive fear to the Transcutaneous Electric Nerve Stimulator (TENS) device and provide a false-positive response on inactivated electrode (absence of current) using the Venham scale.
- Patients who will not be trainable in the standardized lip tapping procedure (could not learn to distinguish the anesthetized numb side from the non-anesthetized side).
- Patients who will not achieve profound numbness after initial LA administration, requiring additional anesthesia using SEM scale.
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 |
|---|---|---|
| Inferior Alveolar Nerve Block administration with laser irradiationPatients will receive inferior alveolar nerve block local anesthesia followed by laser irradiation after completion of the operative procedure. | Other | Test group |
| Inferior Alveolar Nerve Block administrationPatients will not receive any laser irradiation after administration of inferior alveolar nerve block local anesthesia. | Other | Control group |
Primary outcome
Time to recovery of normal lip sensation
Time frame: For two hours after the procedure
Patients will be asked to rate the lower lip numbness on the anesthetized side in comparison to the contralateral non-anesthetized side as described previously. Patients" responses will be recorded every time as "yes" or "no". the number of minutes elapsed from exposure to laser irradiation to the first reported a normal sensation of the lower lip
1 secondary outcome
Assessment of soft tissue injury
Time frame: 24 hours after the procedure
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Dec 2022.
Related trials for Anesthesia, Local
RecruitingPhase 4
Lidocaine Infiltration and Neuroimmunomodulation in Head and Neck Cancer Surgery
Head and Neck Cancer (H&N)
Recruiting
Minimum Effective Local Anesthetic Volume for Ultrasound Guided Superior Trunk Block
Musculoskeletal Diseases or Conditions
RecruitingPhase 3
A Study of Changes to Prostate Procedures
Prostate Cancer
Not yet recruiting
Magnesium Sulphate as an Adjuvant in Combined Costoclavicular Block and Suprascapular Block Versus Interscalene Block for Ambulatory Shoulder Arthroscopy
Postoperative Pain, Shoulder Arthroscopy
Recruiting
Comparison of Spinal Anesthesia With Intrathecal Morphine Versus PENG Block With or Without Dexamethasone in Hip Arthroplasty
Arthropathy of Hip, Hip Osteoarthritis
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Inferior Alveolar Nerve Block administration with laser irradiation and Inferior Alveolar Nerve Block administration in people with Anesthesia, Local, run by Hams Hamed Abdelrahman 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 5 inclusion and 4 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 13 Dec 2022. 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?
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?
Time to recovery of normal lip sensation (time frame: For two hours after the procedure). 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 13 Dec 2022.