Circumferential Supracrestal FiberotomyNCT06221137
Laser Verses Conventional Circumferential Supracrestal Fiberotomy in Orthodontic Extrusion for Crown Lengthening
A study testing conventional circumferential supracrestal fiberotomy and laser circumferential supracrestal fiberotomy in people with Circumferential Supracrestal Fiberotomy and Orthodontic Extrusion, run by Cairo University at 1 site in Egypt.
Trial summary
The aim of this study is to the evaluate the stability of the amount of healthy tooth structure exposed after laser versus conventional technique of fiberotomy during orthodontic extrusion. Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Circumferential Supracrestal Fiberotomy, Orthodontic Extrusion, Crown Lengthening
- What is being tested?
- conventional circumferential supracrestal fiberotomy and laser circumferential supracrestal fiberotomy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jan 2023to Sep 2024
- 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 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Age between 18 and 50 years old
- Teeth in the esthetic zone
- Restorable teeth with successful endodontic treatment
- Adjacent teeth with clinical attachment of at least two-thirds of the root length, thus permitting adequate support for orthodontic movement
- Crown root ratio after extrusion of the needed ferrule amount not less than 1:1
Who cannot join
- Patients with bad oral hygiene or Periodontally affected teeth
- Uncontrolled diabetic patients
- Pregnant females
- Medications that could affect tooth movement (bisphosphonate) radiation therapy less than 2 years
- Moderate-to-heavy daily smokers (who report consuming at least 11 cigarettes/day)
- Teeth with periapical inflammation, ankylosis or vertical root fracture
- Teeth with probability of furcation exposure after extrusion.
- The level of the root is 3 mm or more apical to the level of the bone
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
focality of dentistry Cairo university
Cairo, 11553
Weam A El Battawy, PhD, 01001500537 ext. 0020, Weamelbattawy@dentistry.cu.edu.eg
About this study
Official title: Laser Verses Conventional Circumferential Supracrestal Fiberotomy in Orthodontic Extrusion for Crown Lengthening: A Randomized Controlled Clinical Trial
The aim of this study is to the evaluate the stability of the amount of healthy tooth structure exposed after laser versus conventional technique of fiberotomy during orthodontic extrusion.
Read the detailed description
Parallel groups, two arm, superiority Randomized Controlled Clinical Trial, with 1:1 allocation.
PICO:
Population: patients with endodontically treated teeth and short clinical crown that require crown lengthening in the esthetic zone Intervention: laser fiberotomy with orthodontic extrusion Control: conventional fiberotomy using blade with orthodontic extrusion
Outcomes:
Primary outcome: Stability of the mount of healthy tooth structure exposed.
Secondary outcomes:
- Stability of gingival Margin reference.
- Stability of the alveolar bone.
- Rate of tooth extrusion.
- Sulcus depth.
- Pain Time: 8 weeks after retention
- Being tested
- conventional circumferential supracrestal fiberotomy, laser circumferential supracrestal fiberotomy
- Keywords
- fiberotomy, extrusion, crown lengthening
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
conventional circumferential supracrestal fiberotomyProcedure or surgery
The amount of tooth that need to be extruded will be measured Bonding brackets slot 0,022"x0.028" Roth prescription on piggyback for the tooth with (0.016". x 0.022 ") stainless steel main arch wire and 0.0014" nickel titanium auxiliary.
- Fiberotomy After 2 days of bonding, local anaesthetic solution will be administrated. The depth of the fibrotomy should be equal to the amount of tooth that need to be extruded. supracrustal fibrotomy will be performed using 15 c blade (Carvalho, Bauer et al. 2006)
laser circumferential supracrestal fiberotomyProcedure or surgery
- The amount of tooth that need to be extruded will be measured
- Bonding brackets slot 0,022"x0.028" Roth prescription
- piggyback for the tooth with (0.016". x 0.022 ") stainless steel main arch wire and 0.0014" nickel titanium auxiliary.
- Fiberotomy
- After 2 days of bonding, local anaesthetic solution will be administrated.
- The depth of the fibrotomy should be equal to the amount of tooth that need to be extruded.
- A diode laser of 980 nm wavelength will be used The laser tip will be inserted, and incision will be extended around tooth circumference with the system configured to a continuous wave with the movement of the laser tip in an up and down stroking movement The laser tip will be moved in a circumferential manner taking care that all the fibers are lysed.
| Study group | Role | What they receive |
|---|---|---|
| conventional circumferential supracrestal fiberotomy | Active comparator | * The amount of tooth that need to be extruded will be measured Bonding brackets slot 0,022"x0.028" Roth prescription on piggyback for the tooth with (0.016". x 0.022 ") stainless steel main arch wire and 0.0014" nickel titanium auxiliary.
• Fiberotomy After 2 days of bonding, local anaesthetic solution will be administrated. The depth of the fibrotomy should be equal to the amount of tooth that need to be extruded.
* supracrustal fibrotomy will be performed using 15 c blade (Carvalho, Bauer et al. 2006) Receives: Procedure: conventional circumferential supracrestal fiberotomy |
| laser circumferential supracrestal fiberotomy | Active comparator | * The amount of tooth that need to be extruded will be measured
* Bonding brackets slot 0,022"x0.028" Roth prescription
* piggyback for the tooth with (0.016". x 0.022 ") stainless steel main arch wire and 0.0014" nickel titanium auxiliary.
• Fiberotomy
* After 2 days of bonding, local anaesthetic solution will be administrated.
* The depth of the fibrotomy should be equal to the amount of tooth that need to be extruded.
* A diode laser of 980 nm wavelength will be used The laser tip will be inserted, and incision will be extended around tooth circumference with the system configured to a continuous wave with the movement of the laser tip in an up and down stroking movement The laser tip will be moved in a circumferential manner taking care that all the fibers are lysed. Receives: Procedure: laser circumferential supracrestal fiberotomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Stability of amount of healthy tooth structure exposed
Amount of healthy tooth structure exposed:
This is measured from the 6 guide marks in the acrylic stent around the extruded teeth to the healthy tooth structure using UNC periodontal probe in millimeters.
Measured: 8 weeks after retention.
Secondary outcomes (5)
Stability of gingival Margin
This is measured from the 6 guide marks in the acrylic stent around the extruded teeth to the gingival margin using UNC periodontal probe in millimeters.
Measured: 8 weeks after retention.
Stability of the alveolar bone
This is measured from the 6 guide marks in the acrylic stent around the extruded teeth to the top of the alveolar crest using UNC periodontal probe in millimeters.
This is done after administration of local anesthesia by infiltration around the tooth
Measured: 8 weeks after retention.
Rate of tooth extrusion
This is measured by calculating the average tooth extrusion per week by dividing the amount of healthy tooth structure exposed on the number of weeks.
Measured: 8 weeks after retention.
Sulcus depth
The distance from gingival margin to the base of the sulcus in millimetres.
Measured: 8 weeks after retention.
Post operative pain
VAS scale
Measured: 8 weeks after retention.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jan 2024
- Study start1 Jan 2023
- Primary completionJun 2024 (estimated)
- Study completionSep 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Circumferential Supracrestal FiberotomyStudies 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
- Parallel groups, two arm, superiority Randomized Controlled Clinical Trial, with 1:1 allocation.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, roquaiya eldardear, Cairo University
- Investigators
- Nesma M Shemais, PhD, Study director, Cairo UniversityHeba A Akl, PhD, Study director, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06221137
- Sponsor's protocol ID
- 7-12-22
- Status last verified
- Feb 2024
- First submitted
- 11 Jul 2023
- Last updated
- 28 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Laser Verses Conventional Circumferential Supracrestal Fiberotomy in Orthodontic Extrusion for Crown Lengthening: A Randomized Controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT06221137
- Acronym / sponsor ID
- 7-12-22
- Keywords
- fiberotomy, extrusion, crown lengthening
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 1 Jan 2023 (actual)
- Primary completion
- Jun 2024 (estimated)
- Study completion
- Sep 2024 (estimated)
- First posted
- 24 Jan 2024 (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 this study is to the evaluate the stability of the amount of healthy tooth structure exposed after laser versus conventional technique of fiberotomy during orthodontic extrusion.
Detailed description
Parallel groups, two arm, superiority Randomized Controlled Clinical Trial, with 1:1 allocation.
PICO:
Population: patients with endodontically treated teeth and short clinical crown that require crown lengthening in the esthetic zone Intervention: laser fiberotomy with orthodontic extrusion Control: conventional fiberotomy using blade with orthodontic extrusion
Outcomes:
Primary outcome: Stability of the mount of healthy tooth structure exposed.
Secondary outcomes:
- Stability of gingival Margin reference.
- Stability of the alveolar bone.
- Rate of tooth extrusion.
- Sulcus depth.
- Pain Time: 8 weeks after retention
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Parallel groups, two arm, superiority Randomized Controlled Clinical Trial, with 1:1 allocation.
| Arm | Type | Receives |
|---|---|---|
| conventional circumferential supracrestal fiberotomy | Active comparator | Procedure: conventional circumferential supracrestal fiberotomy* The amount of tooth that need to be extruded will be measured Bonding brackets slot 0,022"x0.028" Roth prescription on piggyback for the tooth with (0.016". x 0.022 ") stainless steel main arch wire and 0.0014" nickel titanium auxiliary. • Fiberotomy After 2 days of bonding, local anaesthetic solution will be administrated. The depth of the fibrotomy should be equal to the amount of tooth that need to be extruded. * supracrustal fibrotomy will be performed using 15 c blade (Carvalho, Bauer et al. 2006) |
| laser circumferential supracrestal fiberotomy | Active comparator | Procedure: laser circumferential supracrestal fiberotomy* The amount of tooth that need to be extruded will be measured * Bonding brackets slot 0,022"x0.028" Roth prescription * piggyback for the tooth with (0.016". x 0.022 ") stainless steel main arch wire and 0.0014" nickel titanium auxiliary. • Fiberotomy * After 2 days of bonding, local anaesthetic solution will be administrated. * The depth of the fibrotomy should be equal to the amount of tooth that need to be extruded. * A diode laser of 980 nm wavelength will be used The laser tip will be inserted, and incision will be extended around tooth circumference with the system configured to a continuous wave with the movement of the laser tip in an up and down stroking movement The laser tip will be moved in a circumferential manner taking care that all the fibers are lysed. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Age between 18 and 50 years old
- Teeth in the esthetic zone
- Restorable teeth with successful endodontic treatment
- Adjacent teeth with clinical attachment of at least two-thirds of the root length, thus permitting adequate support for orthodontic movement
- Crown root ratio after extrusion of the needed ferrule amount not less than 1:1
Key exclusion criteria (8 listed)
- Patients with bad oral hygiene or Periodontally affected teeth
- Uncontrolled diabetic patients
- Pregnant females
- Medications that could affect tooth movement (bisphosphonate) radiation therapy less than 2 years
- Moderate-to-heavy daily smokers (who report consuming at least 11 cigarettes/day)
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 |
|---|---|---|
| conventional circumferential supracrestal fiberotomyThe amount of tooth that need to be extruded will be measured Bonding brackets slot 0,022"x0.028" Roth prescription on piggyback for the tooth with (0.016". x 0.022 ") stainless steel main arch wire and 0.0014" nickel titanium auxiliary. • Fiberotomy After 2 days of bonding, local anaesthetic solution will be administrated. The depth of the fibrotomy should be equal to the amount of tooth that need to be extruded. supracrustal fibrotomy will be performed using 15 c blade (Carvalho, Bauer et al. 2006) | Procedure or surgery | conventional circumferential supracrestal fiberotomy |
| laser circumferential supracrestal fiberotomy* The amount of tooth that need to be extruded will be measured * Bonding brackets slot 0,022"x0.028" Roth prescription * piggyback for the tooth with (0.016". x 0.022 ") stainless steel main arch wire and 0.0014" nickel titanium auxiliary. • Fiberotomy * After 2 days of bonding, local anaesthetic solution will be administrated. * The depth of the fibrotomy should be equal to the amount of tooth that need to be extruded. * A diode laser of 980 nm wavelength will be used The laser tip will be inserted, and incision will be extended around tooth circumference with the system configured to a continuous wave with the movement of the laser tip in an up and down stroking movement The laser tip will be moved in a circumferential manner taking care that all the fibers are lysed. | Procedure or surgery | laser circumferential supracrestal fiberotomy |
Primary outcome
Stability of amount of healthy tooth structure exposed
Time frame: 8 weeks after retention.
Amount of healthy tooth structure exposed: This is measured from the 6 guide marks in the acrylic stent around the extruded teeth to the healthy tooth structure using UNC periodontal probe in millimeters.
5 secondary outcomes
Stability of gingival Margin
Time frame: 8 weeks after retention.
Stability of the alveolar bone
Time frame: 8 weeks after retention.
Rate of tooth extrusion
Time frame: 8 weeks after retention.
Sulcus depth
Time frame: 8 weeks after retention.
Post operative pain
Time frame: 8 weeks after retention.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Feb 2024.
- Individual participant dataSharing planned: No
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.
Nesma M Shemais, PhD study director
Cairo University
Heba A Akl, PhD study director
Cairo University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing conventional circumferential supracrestal fiberotomy and laser circumferential supracrestal fiberotomy in people with Circumferential Supracrestal Fiberotomy and Orthodontic Extrusion, 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 5 inclusion and 8 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 28 Feb 2024. 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?
Contact roquaiya K Elgdardear, BDS (01014455789 ext. 0020, roquaiya.eldardear@dentistry.cu.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Stability of amount of healthy tooth structure exposed (time frame: 8 weeks after retention.). 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 28 Feb 2024.