Laser Verses Conventional Circumferential Supracrestal Fiberotomy in Orthodontic Extrusion for Crown Lengthening

NCT06221137 | Recruiting

• 1 other identifier: 7-12-22
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Circumferential Supracrestal Fiberotomy; Orthodontic Extrusion; Crown Lengthening

Keywords

fiberotomy; extrusion; crown lengthening

Outcome Measures

Primary Outcomes (1)

• 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.

  8 weeks after retention.

Secondary Outcomes (5)

• Stability of gingival Margin

  8 weeks after retention.

• Stability of the alveolar bone

  8 weeks after retention.

• Rate of tooth extrusion

  8 weeks after retention.

• Sulcus depth

  8 weeks after retention.

• Post operative pain

  8 weeks after retention.

Study Arms (2)

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)

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.

Procedure: laser circumferential supracrestal fiberotomy

Interventions

conventional circumferential supracrestal fiberotomy PROCEDURE

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)

conventional circumferential supracrestal fiberotomy

laser circumferential supracrestal fiberotomy PROCEDURE

* 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.

laser circumferential supracrestal fiberotomy

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

focality of dentistry Cairo university

Cairo, 11553, Egypt

RECRUITING

Study Officials

• Nesma M Shemais, PhD

  Cairo University

  STUDY DIRECTOR

• Heba A Akl, PhD

  Cairo University

  STUDY DIRECTOR

Central Study Contacts

roquaiya K Elgdardear, BDS

CONTACT

01014455789; roquaiya.eldardear@dentistry.cu.edu.eg

Weam A El Battawy, PhD

CONTACT

01001500537; Weamelbattawy@dentistry.cu.edu.eg

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Parallel groups, two arm, superiority Randomized Controlled Clinical Trial, with 1:1 allocation.

Study Record Dates

• First Submitted: July 11, 2023
• First Posted: January 24, 2024
• Study Start: January 1, 2023
• Primary Completion: June 1, 2024
• Study Completion: September 1, 2024
• Last Updated: February 28, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)