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

Crown Lengthening Clinical Trial

Official title:

Laser Verses Conventional Circumferential Supracrestal Fiberotomy in Orthodontic Extrusion for Crown Lengthening: A Randomized Controlled Clinical Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06221137
• Other study ID #: 7-12-22
• Status: Recruiting
• Phase: N/A
• Start date: January 1, 2023
• Est. completion date: September 2024

Study information

• Verified date: February 2024
• Source: Cairo University
• Contact: roquaiya K Elgdardear, BDS
• Phone: 01014455789
• Email: roquaiya.eldardear[@]dentistry.cu.edu.eg
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: September 2024
• Est. primary completion date: June 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 50 Years

Eligibility

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

Related Conditions & MeSH terms

• Crown Lengthening

Intervention

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
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.

Locations

Country	Name	City	State
Egypt	focality of dentistry Cairo university	Cairo

Sponsors (1)

Lead Sponsor	Collaborator
Cairo University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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.
Secondary	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.
Secondary	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.
Secondary	Sulcus depth	The distance from gingival margin to the base of the sulcus in millimetres.	8 weeks after retention.
Secondary	Post operative pain	VAS scale	8 weeks after retention.