Lingual FrenumNCT04487418
Evaluation of the Effects of High-level Laser and Electro-cautery in Lingual Frenotomy Surgeries in Infants
A study testing Electro cautery surgery and High power diode laser surgery in people with Lingual Frenum and High Power Laser, run by University of Nove de Julho.
Trial summary
Ankyloglossia is an anomaly that is characterized by an abnormally short, thick or thin lingual frenulum that can restrict the movements of the tongue and has been identified as one of the factors that can negatively interfere with breastfeeding, decreasing the ability of the newborn to make a clamp proper. Read more about this study
- Who is it for?
- Ages Up to 3 months
- Conditions the study is for
- Lingual Frenum, High Power Laser, Breast Feeding
- What is being tested?
- Electro cautery surgery and High power diode laser surgery
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 56 participants
- Where
- No sites listed yet
- Study dates
- 3 Sep 2020to 3 Nov 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 Up to 3 months
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 0 to 3 months old
- Infants born within normal health standards
- Infants who are breastfeeding
- Have a diagnosis of ankyloglossia with a score of 0 to 4 according to the Bristol protocol, performed by a Speech Therapist and / or Dental Surgeon and / or Pediatrician.
Who cannot join
- Infants with changes:
- Congenital and systemic
- Blood dyscrasias
- Hemophilia, diabetes
- Nutritional weaknesses
- Imunodeficiencies
Show all 10Show fewer
- Changes in the oral cavity
- Infants who are under medical treatment
- Use of medication
- Do not be well on the day of the surgical procedure.
About this study
Official title: Evaluation of the Effects of High-level Laser and Electro-cautery in Lingual Frenotomy Surgeries in Infants - Blinded Randomized Controlled Clinical Study
Ankyloglossia is an anomaly that is characterized by an abnormally short, thick or thin lingual frenulum that can restrict the movements of the tongue and has been identified as one of the factors that can negatively interfere with breastfeeding, decreasing the ability of the newborn to make a clamp proper. According to the Ministry of Health in Brazil, the percentage of newborns who present this anomaly is 3% to 16%. The objective of the study will be to evaluate the release of the lingual frenulum through the lingual frenotomy performed with a high level diode laser or with an electro cautery. Methods: The present study will be a blind randomized controlled clinical trial, in which 56 volunteers, infants aged 0 to 3 months, with normal health status, who are breastfeeding, diagnosed with ankyloglossia and indication for surgery, will do lingual frenotomy. Those responsible for the children will be informed about the study procedures and after signing the Free and Informed Consent Form, authorizing them to participate in the study. The non-blinded researcher will conduct the evaluation, screening and procedures, and another blinded researcher will be the evaluator 15 days after the procedure. The distribution of volunteers in the groups will be random and randomized: Surgery Group with electro cautery (G1- EC) and Surgery Group with high power diode laser (G2-L). The procedures for patient preparation, asepsis and infection control will be strictly followed in accordance with biosafety rules. In both groups the infants will be submitted to anamnesis, clinical evaluation and standardized photograph of the lingual frenulum region before the surgical procedure and application of the Bristol frenulum evaluation protocol, the nursing mother will be submitted to the evaluation of the VAS of pain during breastfeeding, before, shortly after and 15 days after the surgical procedure for the evaluation of the result of the lingual frenotomy. Discussion: Ankyloglossia can negatively impact breastfeeding. The lingual frenotomy procedure can be performed using various surgical techniques. The use of high-power laser for this purpose has been identified as an effective resource in the incision of the lingual frenulum, with advantages in the trans-operative period, less bleeding and better visualization of the surgical field, and in the post-operative period, with reduction of edema, pain and inflammation, quality of tissue repair and patient comfort.
- Conditions
- Lingual Frenum, High Power Laser, Breast Feeding
- Being tested
- Electro cautery surgery, High power diode laser surgery
- Medical subject headings
- Breast Feeding
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Electro cautery surgeryProcedure or surgery
Pre-anesthetics with therapeutic topic (benzocaine) will be administered and, as an anesthetic, or use of anesthetic drops (benzocaine or tetracaine) or local infiltrative anesthesia (2% lidocaine 1: 100,000 with adrenaline).
The surgery will be carried out with cauterization for incision of the lingual brake, division of the brake fibers and release, removing the brake fibers that are stored in the anterior ventral free parts of the tongue until reaching the base of the tongue, which are removed or cleaned, lingual movement, and the anterior axis of the tongue is repositioned or lingual brake in that region. No sutures will be performed and should be oriented on the formation of a pseudo-membranous repair plate in the second intention that will be formed between the first and the third day after surgery.
Postoperative care:
Guidance will be given to the person responsible for not bringing objects to the mouth that may hurt.
High power diode laser surgeryProcedure or surgery
Pre-anesthetics with therapeutic topic (benzocaine) and as anesthetic or use of anesthetic eye drops (benzocaine or tetracaine) or local infiltrative anesthesia (2% lidocaine 1: 100,000 with adrenaline) will be administered. The surgery will be performed with a high power diode laser (TW Surgical, MMOptics - São Carlos - Brazil). 808 nm wavelength, which can be operated in continuous or interrupted mode. Wattages from 1 to 1.5 W, up to a maximum of 2 W, can be used and must carefully respect the histological characteristics of the target tissue and the signs of overheating and carbonization, so that the choice of parameters is dynamic and very dependent on experience, mastery and care for the operator.
Preoperative care: Guidance will be given to the person responsible for not bringing objects to the mouth that may hurt.
| Study group | Role | What they receive |
|---|---|---|
| Surgery group with electro cautery | Experimental | Surgery will be performed with electro cautery. Receives: Procedure: Electro cautery surgery |
| High level diode laser surgery | Experimental | High power diode laser surgery will be performed. Receives: Procedure: High power diode laser surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
Photograph of the lingual brake region
An intraoral photograph will be performed on the planes: frontal, median sagittal of the patient, parallel to the vertical edges and occlusal to the horizontal edges with the focus on the lingual brake region. The evaluation will be performed after the surgical procedure, and after 15 days.
Measured: 10 minutes
BRISOL
The baby will be placed on the lap of one of the guardians, adult, in the supine position, who in turn is lying in the dental chair, in some situations the knee-to-knee position may be used, and the professional should assess which will be more convenient for stabilization. protective of the patient.
asepsis and infection control for the patient, will be strictly followed in accordance with Biosafety rules.
In the Bristol protocol we will have a final score based on 4 points to observe: appearance of the tip of the tongue, fixation of the brake in the lower alveolus, elevation of the tongue during crying and protrusion of the tongue on the gums The evaluation will be carried out immediately after the surgery and after 15 days.
Measured: 15 minutes
Secondary outcomes (1)
Visual analogue scale (VAS)
The application of the VAS pain scale will be applied to the nursing mother during breastfeeding before, shortly after and 15 days after the surgical procedure. During breastfeeding, the nursing mother will be asked about the pain in the breasts, and she must report the pain by looking at the scale mentioned, from 0 to 10 and choose the number that most relates to breast pain.
Measured: 10 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jul 2020
- Study start3 Sep 2020 (estimated)
- Primary completion1 Sep 2021 (estimated)
- Study completion3 Nov 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Lingual FrenumStudies 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
- Double blind
- Who is masked
- Care provider, Outcomes assessor
- Enrolment
- 56 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Nove de Julho
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sandra Kalil Bussadori, University of Nove de Julho
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04487418
- Sponsor's protocol ID
- lingualfrenotomy
- Status last verified
- Jul 2020
- First submitted
- 24 Jul 2020
- Last updated
- 27 Jul 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Publications
Mazzoni A, Navarro RS, Fernandes KPS, Horliana ACRT, Mesquita-Ferrari RA, Motta PB, Silva T, Gomes AO, Martimbianco ALC, Sobral APT, Santos EM, Motta LJ, Bussadori SK. Evaluation of the effects of high-level laser and electrocautery in lingual frenectomy surgeries in infants: protocol for a blinded randomised controlled clinical trial. BMJ Open. 2021 Nov 30;11(11):e050733. doi: 10.1136/bmjopen-2021-050733.
PubMed 34848514
Study at a glance
From the registry record, last updated by the sponsor on 27 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Effects of High-level Laser and Electro-cautery in Lingual Frenotomy Surgeries in Infants - Blinded Randomized Controlled Clinical Study
- ClinicalTrials.gov ID
- NCT04487418
- Acronym / sponsor ID
- lingualfrenotomy
- Conditions
- Lingual Frenum, High Power Laser, Breast Feeding
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 56 participants (estimated)
- Lead sponsor
- University of Nove de JulhoUniversity, hospital or other
- Study start
- 3 Sep 2020 (estimated)
- Primary completion
- 1 Sep 2021 (estimated)
- Study completion
- 3 Nov 2021 (estimated)
- First posted
- 27 Jul 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.
Ankyloglossia is an anomaly that is characterized by an abnormally short, thick or thin lingual frenulum that can restrict the movements of the tongue and has been identified as one of the factors that can negatively interfere with breastfeeding, decreasing the ability of the newborn to make a clamp proper. According to the Ministry of Health in Brazil, the percentage of newborns who present this anomaly is 3% to 16%. The objective of the study will be to evaluate the release of the lingual frenulum through the lingual frenotomy performed with a high level diode laser or with an electro cautery. Methods: The present study will be a blind randomized controlled clinical trial, in which 56 volunteers, infants aged 0 to 3 months, with normal health status, who are breastfeeding, diagnosed with ankyloglossia and indication for surgery, will do lingual frenotomy. Those responsible for the children will be informed about the study procedures and after signing the Free and Informed Consent Form, authorizing them to participate in the study. The non-blinded researcher will conduct the evaluation, screening and procedures, and another blinded researcher will be the evaluator 15 days after the procedure. The distribution of volunteers in the groups will be random and randomized: Surgery Group with electro cautery (G1- EC) and Surgery Group with high power diode laser (G2-L). The procedures for patient preparation, asepsis and infection control will be strictly followed in accordance with biosafety rules. In both groups the infants will be submitted to anamnesis, clinical evaluation and standardized photograph of the lingual frenulum region before the surgical procedure and application of the Bristol frenulum evaluation protocol, the nursing mother will be submitted to the evaluation of the VAS of pain during breastfeeding, before, shortly after and 15 days after the surgical procedure for the evaluation of the result of the lingual frenotomy. Discussion: Ankyloglossia can negatively impact breastfeeding. The lingual frenotomy procedure can be performed using various surgical techniques. The use of high-power laser for this purpose has been identified as an effective resource in the incision of the lingual frenulum, with advantages in the trans-operative period, less bleeding and better visualization of the surgical field, and in the post-operative period, with reduction of edema, pain and inflammation, quality of tissue repair and patient comfort.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Surgery group with electro cautery | Experimental | Procedure: Electro cautery surgerySurgery will be performed with electro cautery. |
| High level diode laser surgery | Experimental | Procedure: High power diode laser surgeryHigh power diode laser surgery will be performed. |
Who may qualify
- Ages
- Up to 3 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- 0 to 3 months old
- Infants born within normal health standards
- Infants who are breastfeeding
- Have a diagnosis of ankyloglossia with a score of 0 to 4 according to the Bristol protocol, performed by a Speech Therapist and / or Dental Surgeon and / or Pediatrician.
Key exclusion criteria (10 listed)
- Infants with changes:
- Congenital and systemic
- Blood dyscrasias
- Hemophilia, diabetes
- Nutritional weaknesses
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 |
|---|---|---|
| Electro cautery surgeryPre-anesthetics with therapeutic topic (benzocaine) will be administered and, as an anesthetic, or use of anesthetic drops (benzocaine or tetracaine) or local infiltrative anesthesia (2% lidocaine 1: 100,000 with adrenaline). The surgery will be carried out with cauterization for incision of the lingual brake, division of the brake fibers and release, removing the brake fibers that are stored in the anterior ventral free parts of the tongue until reaching the base of the tongue, which are removed or cleaned, lingual movement, and the anterior axis of the tongue is repositioned or lingual brake in that region. No sutures will be performed and should be oriented on the formation of a pseudo-membranous repair plate in the second intention that will be formed between the first and the third day after surgery. Postoperative care: Guidance will be given to the person responsible for not bringing objects to the mouth that may hurt. | Procedure or surgery | Surgery group with electro cautery |
| High power diode laser surgeryPre-anesthetics with therapeutic topic (benzocaine) and as anesthetic or use of anesthetic eye drops (benzocaine or tetracaine) or local infiltrative anesthesia (2% lidocaine 1: 100,000 with adrenaline) will be administered. The surgery will be performed with a high power diode laser (TW Surgical, MMOptics - São Carlos - Brazil). 808 nm wavelength, which can be operated in continuous or interrupted mode. Wattages from 1 to 1.5 W, up to a maximum of 2 W, can be used and must carefully respect the histological characteristics of the target tissue and the signs of overheating and carbonization, so that the choice of parameters is dynamic and very dependent on experience, mastery and care for the operator. Preoperative care: Guidance will be given to the person responsible for not bringing objects to the mouth that may hurt. | Procedure or surgery | High level diode laser surgery |
Primary outcome
Photograph of the lingual brake region
Time frame: 10 minutes
An intraoral photograph will be performed on the planes: frontal, median sagittal of the patient, parallel to the vertical edges and occlusal to the horizontal edges with the focus on the lingual brake region. The evaluation will be performed after the surgical procedure, and after 15 days.
BRISOL
Time frame: 15 minutes
The baby will be placed on the lap of one of the guardians, adult, in the supine position, who in turn is lying in the dental chair, in some situations the knee-to-knee position may be used, and the professional should assess which will be more convenient for stabilization. protective of the patient. asepsis and infection control for the patient, will be strictly followed in accordance with Biosafety rules. In the Bristol protocol we will have a final score based on 4 points to observe: appearance of the tip of the tongue, fixation of the brake in the lower alveolus, elevation of the tongue during crying and protrusion of the tongue on the gums The evaluation will be carried out immediately after the surgery and after 15 days.
1 secondary outcome
Visual analogue scale (VAS)
Time frame: 10 minutes
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jul 2020.
- Derived from this study: PubMed 34848514Mazzoni A, Navarro RS, Fernandes KPS, Horliana ACRT, Mesquita-Ferrari RA, Motta PB, Silva T, Gomes AO, Martimbianco ALC, Sobral APT, Santos EM, Motta LJ, Bussadori SK. Evaluation of the effects of high-level laser and electrocautery in lingual frenectomy surgeries in infants: protocol for a blinded randomised controlled clinical trial. BMJ Open. 2021 Nov 30;11(11):e050733. doi: 10.1136/bmjopen-2021-050733.
- Individual participant dataSharing planned: Yes
Related trials for Lingual Frenum
Active, not recruiting
Lingual Frenulum in Newborn Infants (LINNE)
Tongue Tie, Frenulum Breve
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.
Questions about this trial
What is this clinical trial studying?
A study testing Electro cautery surgery and High power diode laser surgery in people with Lingual Frenum and High Power Laser, run by University of Nove de Julho.
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 4 inclusion and 10 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 27 Jul 2020. Status can change between updates, so confirm with the study contact before making plans.
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?
Photograph of the lingual brake region (time frame: 10 minutes). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04487418, which also lists 1 linked publication.
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 27 Jul 2020.