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

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.

Study Overview

• Status: Recruiting
• Conditions: Crown Lengthening; Circumferential Supracrestal Fiberotomy; Orthodontic Extrusion
• Intervention / Treatment: Procedure: conventional circumferential supracrestal fiberotomy; Procedure: laser circumferential supracrestal fiberotomy

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 Type: Interventional
• Enrollment (Estimated): 20
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: roquaiya K Elgdardear, BDS; Phone Number: 0020 01014455789; Email: roquaiya.eldardear@dentistry.cu.edu.eg
• Study Contact Backup: Name: Weam A El Battawy, PhD; Phone Number: 0020 01001500537; Email: Weamelbattawy@dentistry.cu.edu.eg

Study Locations

• Egypt
  • Cairo, Egypt, 11553
    • Recruiting
    • focality of dentistry Cairo university
    • Contact: Weam A El Battawy, PhD; Phone Number: 0020 01001500537; Email: Weamelbattawy@dentistry.cu.edu.eg

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: 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)	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)
Active Comparator: 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: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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	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.	8 weeks after retention.
Sulcus depth	The distance from gingival margin to the base of the sulcus in millimetres.	8 weeks after retention.
Post operative pain	VAS scale	8 weeks after retention.

Collaborators and Investigators

• Sponsor: Cairo University
• Investigators: Study Director: Nesma M Shemais, PhD, Cairo University; Study Director: Heba A Akl, PhD, Cairo University

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2023
• Primary Completion (Estimated): June 1, 2024
• Study Completion (Estimated): September 1, 2024

Study Registration Dates

• First Submitted: July 11, 2023
• First Submitted That Met QC Criteria: January 22, 2024
• First Posted (Actual): January 24, 2024

Study Record Updates

• Last Update Posted (Actual): February 28, 2024
• Last Update Submitted That Met QC Criteria: February 25, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Keywords: extrusion; crown lengthening; fiberotomy
• Other Study ID Numbers: 7-12-22

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No