Frenulum; ElongationNCT03965455
Clinical Efficacy of Conventional and Diode Laser-Assisted Frenectomy in Patients With Abnormal Different Frenum Insertions: A Retrospective Study
An observational study of Frenulum; Elongation, run by Marmara University at 1 site in Turkey (Türkiye).
Trial summary
Aim: The aim of this retrospective study was to assess the frenum attachment recurrence and evaluate clinical parameters after conventional and diode laser-assisted frenectomy in patients with different abnormal frenum insertions. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Frenulum; Elongation
- What is being tested?
- Diode laser and Conventional
- Type of treatment
- Pill or oral medicine, Medical device, Surgery or procedure
- How many people
- 70 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 23 Feb 2018to 28 Nov 2018
- Phase
- Observational
- 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 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: This study utilized treatment records of patients treated with maxillary labial frenectomy in the Clinics of Periodontology, Faculty of Dentistry, Marmara University.
Who may be able to join
- systemically healthy, (b) nonsmoker, (c) aged between 18 and 65 years, (d) received initial periodontal treatment before frenectomy, (e) presence of central and lateral incisors and canines at maxilla, (f) not received any kind of periodontal surgery, prosthodontic and restorative treatment which may affect the anatomy of the relevant region.
Who cannot join
- Subjects with incomplete documentation and without at least 6-week follow-up observation were excluded.
Trial locations and contacts
1 site in 1 country.
About this study
Aim: The aim of this retrospective study was to assess the frenum attachment recurrence and evaluate clinical parameters after conventional and diode laser-assisted frenectomy in patients with different abnormal frenum insertions.
Methods: Data records of 429 patients treated with maxillary labial frenectomy between January 1, 2016 and January 1, 2018 were screened. Records of 70 patients meeting the inclusion criteria were evaluated. Data were analyzed in terms of gender, age, category of frenum, presence of diastema, operation technique, type of periodontal disease. The distance between frenum attachment and mucogingival junction (FMGJ), plaque index (PI), gingival index (GI) and probing depth were assessed.
- Conditions
- Frenulum; Elongation
- Being tested
- Diode laser, Conventional
- Keywords
- labial frenum, laser therapy, recurrence, oral hyigiene
- Medical subject headings
- Recurrence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Diode laserDevice
Also called frenectomy
In the laser-assisted frenectomy, a diode laser device (GIGA Cheese II®, China) (λ= 810 nm) with a 400 µm diameter, plain-ended optical fiber tip was used for the procedure maintaining contact with oral mucosa at 2,5 W, 70 Hz frequency with a short pulse (140 microseconds) duration.
ConventionalProcedure or surgery
Also called frenectomy
In the conventional frenectomy, the incisions were applied using a scalpel blade no.15 on the upper and lower surface of the haemostat until the frenum was excised.
| Study group | Role | What they receive |
|---|---|---|
| conventional group | Not described Receives: Procedure: Conventional | |
| diode laser group | Not described Receives: Device: Diode laser |
What is being measured
The primary outcome is the main question the study is designed to answer.
recurrence
Recurrence is evaluated by the formation of an intact mucosa with the frenum attached to its new position
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 May 2019
- Study start23 Feb 2018
- Primary completion28 Nov 2018
- Study completion28 Nov 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Frenulum; ElongationStudies of the same condition, open and under way.
- More trials run by Marmara 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
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- Marmara University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03965455
- Sponsor's protocol ID
- 2018-164
- Status last verified
- May 2019
- First submitted
- 24 May 2019
- Last updated
- 29 May 2019
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Efficacy of Conventional and Diode Laser-Assisted Frenectomy in Patients With Abnormal Different Frenum Insertions: A Retrospective Study
- ClinicalTrials.gov ID
- NCT03965455
- Acronym / sponsor ID
- 2018-164
- Conditions
- Frenulum; Elongation
- Keywords
- labial frenum, laser therapy, recurrence, oral hyigiene
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- Marmara UniversityUniversity, hospital or other
- Study start
- 23 Feb 2018 (actual)
- Primary completion
- 28 Nov 2018 (actual)
- Study completion
- 28 Nov 2018 (actual)
- First posted
- 29 May 2019 (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.
Aim: The aim of this retrospective study was to assess the frenum attachment recurrence and evaluate clinical parameters after conventional and diode laser-assisted frenectomy in patients with different abnormal frenum insertions.
Methods: Data records of 429 patients treated with maxillary labial frenectomy between January 1, 2016 and January 1, 2018 were screened. Records of 70 patients meeting the inclusion criteria were evaluated. Data were analyzed in terms of gender, age, category of frenum, presence of diastema, operation technique, type of periodontal disease. The distance between frenum attachment and mucogingival junction (FMGJ), plaque index (PI), gingival index (GI) and probing depth were assessed.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| conventional group | – | Procedure: Conventional |
| diode laser group | – | Device: Diode laser |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- This study utilized treatment records of patients treated with maxillary labial frenectomy in the Clinics of Periodontology, Faculty of Dentistry, Marmara University.
Key inclusion criteria (1 listed)
- systemically healthy, (b) nonsmoker, (c) aged between 18 and 65 years, (d) received initial periodontal treatment before frenectomy, (e) presence of central and lateral incisors and canines at maxilla, (f) not received any kind of periodontal surgery, prosthodontic and restorative treatment which may affect the anatomy of the relevant region.
Key exclusion criteria (1 listed)
- Subjects with incomplete documentation and without at least 6-week follow-up observation were excluded.
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 |
|---|---|---|
| Diode laserAlso: frenectomyIn the laser-assisted frenectomy, a diode laser device (GIGA Cheese II®, China) (λ= 810 nm) with a 400 µm diameter, plain-ended optical fiber tip was used for the procedure maintaining contact with oral mucosa at 2,5 W, 70 Hz frequency with a short pulse (140 microseconds) duration. | Device | diode laser group |
| ConventionalAlso: frenectomyIn the conventional frenectomy, the incisions were applied using a scalpel blade no.15 on the upper and lower surface of the haemostat until the frenum was excised. | Procedure or surgery | conventional group |
Primary outcome
recurrence
Time frame: 6 weeks
Recurrence is evaluated by the formation of an intact mucosa with the frenum attached to its new position
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 29 May 2019.
Related trials for Frenulum; Elongation
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Frenulum; Elongation, run by Marmara University at 1 site in Turkey (Türkiye).
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 1 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 29 May 2019. 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 Turkey (Türkiye). 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?
recurrence (time frame: 6 weeks). 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 29 May 2019.