Assessment of Growth Factors Levels Associated with Wound Healing After Soft Tissue Crown Lengthening

January 29, 2025 updated by: Asem Mohammed Kamel Ali, Al-Azhar University

Soft Tissue Crown Lengthening and Attached Gingiva Remodeling: Assessment of Growth Factors Levels Associated with Wound Healing

Clinicians often encounter the need for crown lengthening in the practice of dentistry and have to make treatment decisions taking into consideration how to best address the biological, functional, and esthetic requirements of each particular case. The concept of crown lengthening was first introduced by D.W. Cohen (1962) and is presently a procedure that often employs some combination of tissue reduction or removal , osseous surgery , and/or orthodontics for tooth exposure and increasing the extent of supra gingival tooth structure for restoration of aesthetic purposes . Gingivectomy and gingivoplasty considered kind of crown lengthening procedure. Gingivectomy is defined as the excision of the soft tissue wall of a pocket. The procedure is usually combined with the recontouring of hyperplastic tissue by gingivectoplasty to restore physiological gingival form . Gingivoplasty is a reshaping of the gingiva to create physiologic gingival contours, with the sole purpose of recontouring the gingiva in the absence of pockets. In doing so, the complete anatomical crown becomes exposed and pseudo pockets are eliminated creating a better environment for periodontal health. Treatment options for crown lengthening procedures include: Surgical, Electrocautery or by Laser. The aim of the present study was to compare the practical effectiveness and postoperative parameters of using diode laser and electrocautery for crown lengthening procedure.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

80

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
      • Assiut, Egypt, 71524
        • Faculty of dental medicine, Al-Azhar University (Assiut branch)

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

1. Men and women aged ≥ 18 years. 2. Patients with short clinical crowns to enhance esthetic, exposure of subgingival caries for prosthetic replacement, exposure of a fracture or combination. 3. All patients were free from any systemic diseases according to the criteria of Modified Cornell Medical Index. 4. All patients need soft tissue removal and don't need osseous resection. 5. Full-Mouth Plaque Score (FMPS) ≤ 20% at baseline. 6. Full-Mouth Bleeding Score (FMBS) ≤ 20% at baseline.

Exclusion Criteria:

1. Light smokers i.e. smoking > 10 cigarettes/day. 2. Patients with medical conditions contraindicating surgical interventions. 3. Pregnancy or lactation. 4. Patients with active periodontal disease (PD ≥ 6 mm) 5. Clinical and/or radiographic signs of periapical pathology. 6. Patients with pacemakers.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Laser crown lengthening technique
1-The patients were anesthetized using infiltration technique and/ or nerve block. 2-Specific protective glasses were used for patient, dentist, and assistant. Highly reflective instruments or instruments with mirrored surface were voided as there could be reflection of the laser beam. 3- The pocket depths in the surgical site were measured. Dots made in the gingiva by using Krane Kaplen tweezer, then area to be cut outlined by connection of dots (fig.6(D)) using Sirolase ® lower power diode laser 970 ± 15 nm (0.5 watts) continuous emission, power =3 watts, fiber 320 μm (fig.8). 4-Continue to split the dots halfway until there was a continuing line of dots by using the diode laser, 5-During the entire procedure, the tip was constantly checked for any debris of the ablated tissues and was cleaned with sterile moist gauze.6-Physiological gingival contour was achieved by changing the angulation of the tip as required during the procedure. 7-After the surgery, the end of the fiber (2-3mm)
Device: single intervention by Sirolase ® lower power diode laser 970 ± 15 nm (0.5 watts) continuous emission, power =3 watts, fiber 320 μm
single intervention by Sirolase ® lower power diode laser 970 ± 15 nm (0.5 watts) continuous emission, power =3 watts, fiber 320 μm.single intervention the follow-up until 6 months
Active Comparator: Electrocautery crown lengthening
1-Patients were anesthetized by infiltration technique and/ or nerve block 2-The pocket depths in the surgical site were measured using crane Kaplan tweezer. 3-Patient asked to hold the reusable silicone patient plate. 4-The output power of electrosurgical unit (fig.6) was kept 38 watts rms ± 5%. The working frequency was adjusted to 1.5 MHz ± 5%. 5-Continue to split the dots halfway until there was a continuing line of dots. 6-Avoid the operation of equipment in a room with flammable or explosive materials. 7-Rapid, well-planned movements without pressure and it should be like brushing strokes keep electrode moving all the time, use high enough current. 8-A cooling period of 8 seconds should be allowed between successive incisions with the electrode. 9-Continuous saline irrigation was given while using the electrocautery. 10-The excised tissues are removed with Orban knife.
Device: single intervention by electrosurgical unit which was kept 38 watts rms ± 5%. The working frequency was adjusted to 1.5 MHz ± 5%.
single intervention by electrosurgical unit which was kept 38 watts rms ± 5%. The working frequency was adjusted to 1.5 MHz ± 5%.single intervention then follow-up until 6 months

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Epithelization rate
Time Frame: From enrollment to the end of treatment at 3 weeks
After gingivectomy operation, the surgical site was evaluated with hydrogen peroxide to detect the presence of epithelization. The mesio-distal width of the maxillary right central tooth was recorded for each patient, and photographs were calibrated via the reference values. all photographs were examined with the assistance of Image processing and analysis in Java, Image J software. In the areas subjected to hydrogen peroxide application and experiencing tissue reaction, there was a lack of an epithelial layer in the wound area.
From enrollment to the end of treatment at 3 weeks
Transforming Growth Factor-β1 (TGF-β1) levels assessment
Time Frame: From enrollment to the end of treatment at 8 weeks
The levels of TGF-β1 in the GCF samples were determined using commercially available ELISA Kits
From enrollment to the end of treatment at 8 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Al-Azhar University

Investigators

  • Principal Investigator: Asem M lecturer, PhD, Faculty of dental medicine, Al-Azhar University (Assiut branch)

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 3, 2021

Primary Completion (Actual)

June 20, 2023

Study Completion (Actual)

December 27, 2023

Study Registration Dates

First Submitted

January 29, 2025

First Submitted That Met QC Criteria

January 29, 2025

First Posted (Actual)

March 25, 2025

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

January 29, 2025

Last Verified

January 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • crown lengthening and gingiva

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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