Labial TieNCT03104764
Labial Frenulum Surgery - a Comparative Study of Conventional Scalpel and Er-Yag Laser Technique
A study testing Scalpel and Er:YAG laser in people with Labial Tie, run by Public Dental Health in Uppsala Region at 1 site in Sweden.
Trial summary
The aim of the study was to compare the outcome in terms of wound healing time, surgery time, bleeding and patient experience of the ectomy of frenulum when performed with laser technology versus conventional scalpel technique. A prospective, single-blind, randomized and controlled study was performed. Read more about this study
- Who is it for?
- Ages 7 to 15 years
- Conditions the study is for
- Labial Tie
- What is being tested?
- Scalpel and Er:YAG laser
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteSweden
- Study dates
- 1 Aug 2014to 25 Jan 2016
- 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 7 to 15 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- patients in need of frenulum labials surgery
Who cannot join
- patients with severe general diseases (ASA>2)
- patients who required general anaesthesia for treatment
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of Wound Healing and Patients´Experiences of Labial Frenulum Surgery - a Randomized, Controlled Comparative Study of Conventional Scalpel Technique and Er-Yag Laser Technique
The aim of the study was to compare the outcome in terms of wound healing time, surgery time, bleeding and patient experience of the ectomy of frenulum when performed with laser technology versus conventional scalpel technique. A prospective, single-blind, randomized and controlled study was performed. Wound healing was assessed five and ten days after after surgery. The long-term outcome were assessed blinded by a dentist not earlier involved in the study.
Read the detailed description
Children referred to a pediatric clinic to surgically remove a labial frenulum were randomized to treatment with conventional scalpel or laser treatment technology after parents and children had given consent to participate. During the surgery the time required for the procedure and the amount of bleeding the different techniques caused were measured. Wound healing was assessed five and ten days after surgery by a clinical judgement and by analysing photos. Three months after surgery an independent dentist assessed the long-term outcome by a clinical examination. The patients´ view of the treatment were assessed directly after the surgery and five days, ten days and three months after the surgery.
- Conditions
- Labial Tie
- Being tested
- Scalpel, Er:YAG laser
- Keywords
- labial frenulum, surgery, scalpel technique, Er:YAG laser
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ScalpelDevice
Labial frenulum removed by scalpel
Er:YAG laserDevice
Labial frenulum removed by Er:YAG laser
| Study group | Role | What they receive |
|---|---|---|
| Scalpel | Active comparator | Frenotomy performed with conventional scalpel Receives: Device: Scalpel |
| Er:YAG laser | Experimental | Frenotomy performed with Er:YAG laser Receives: Device: Er:YAG laser |
What is being measured
The primary outcome is the main question the study is designed to answer.
Wound healing
Time period until reepithelialized measured clinically and on photos
Measured: 0-3 months
Secondary outcomes (3)
Patient experience
Patients´experiences of surgery procedures measured through questionnaires
Measured: 0-3 months
Time required for surgery
The time required for the surgical process is measured with timer
Measured: Intervention day
Scar tissue formation
prevalence of scar tissue formation assessed by a clinical investigation
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Apr 2017
- Study start1 Aug 2014
- Primary completion4 Nov 2015
- Study completion25 Jan 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Labial TieStudies 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
- Model description
- Prospective, randomized, controlled, single-blind investigation
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Public Dental Health in Uppsala Region
- Sponsor type
- University, hospital or other
- Collaborators
- Göteborg University
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03104764
- Sponsor's protocol ID
- Dnr 2014/253
- Status last verified
- Sep 2014
- First submitted
- 3 Apr 2017
- Last updated
- 11 Apr 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data are not planned to be shared
Study at a glance
From the registry record, last updated by the sponsor on 11 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Wound Healing and Patients´Experiences of Labial Frenulum Surgery - a Randomized, Controlled Comparative Study of Conventional Scalpel Technique and Er-Yag Laser Technique
- ClinicalTrials.gov ID
- NCT03104764
- Acronym / sponsor ID
- Dnr 2014/253
- Conditions
- Labial Tie
- Keywords
- labial frenulum, surgery, scalpel technique, Er:YAG laser
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Public Dental Health in Uppsala RegionUniversity, hospital or other
- Collaborators
- Göteborg University
- Study start
- 1 Aug 2014 (actual)
- Primary completion
- 4 Nov 2015 (actual)
- Study completion
- 25 Jan 2016 (actual)
- First posted
- 7 Apr 2017 (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.
The aim of the study was to compare the outcome in terms of wound healing time, surgery time, bleeding and patient experience of the ectomy of frenulum when performed with laser technology versus conventional scalpel technique. A prospective, single-blind, randomized and controlled study was performed. Wound healing was assessed five and ten days after after surgery. The long-term outcome were assessed blinded by a dentist not earlier involved in the study.
Detailed description
Children referred to a pediatric clinic to surgically remove a labial frenulum were randomized to treatment with conventional scalpel or laser treatment technology after parents and children had given consent to participate. During the surgery the time required for the procedure and the amount of bleeding the different techniques caused were measured. Wound healing was assessed five and ten days after surgery by a clinical judgement and by analysing photos. Three months after surgery an independent dentist assessed the long-term outcome by a clinical examination. The patients´ view of the treatment were assessed directly after the surgery and five days, ten days and three months after the surgery.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Prospective, randomized, controlled, single-blind investigation
| Arm | Type | Receives |
|---|---|---|
| Scalpel | Active comparator | Device: ScalpelFrenotomy performed with conventional scalpel |
| Er:YAG laser | Experimental | Device: Er:YAG laserFrenotomy performed with Er:YAG laser |
Who may qualify
- Ages
- 7 to 15 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- patients in need of frenulum labials surgery
Key exclusion criteria (2 listed)
- patients with severe general diseases (ASA>2)
- patients who required general anaesthesia for 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 |
|---|---|---|
| ScalpelLabial frenulum removed by scalpel | Device | Scalpel |
| Er:YAG laserLabial frenulum removed by Er:YAG laser | Device | Er:YAG laser |
Primary outcome
Wound healing
Time frame: 0-3 months
Time period until reepithelialized measured clinically and on photos
3 secondary outcomes
Patient experience
Time frame: 0-3 months
Time required for surgery
Time frame: Intervention day
Scar tissue formation
Time frame: 3 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 11 Apr 2017.
- Individual participant dataSharing planned: No. Individual participant data are not planned to be shared
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 Scalpel and Er:YAG laser in people with Labial Tie, run by Public Dental Health in Uppsala Region at 1 site in Sweden.
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 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: finished, as of the sponsor's last update on 11 Apr 2017. 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 Sweden. 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?
Wound healing (time frame: 0-3 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 11 Apr 2017.