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NCT Number: NCT06806319

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

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.

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Key information

Conditions

Gingival Overgrowth Body Temperature Changes Bone Diseases Bone Diseases, Developmental Camurati-Engelmann Syndrome Congenital, Hereditary, and Neonatal Diseases and Abnormalities Genetic Diseases, Inborn Gingival Diseases Heat Stress Disorders Hyperthermia Mouth Diseases Musculoskeletal Diseases Osteochondrodysplasias Pathological Conditions, Signs and Symptoms Periodontal Diseases Signs and Symptoms Stomatognathic Diseases Wounds and Injuries

Age range

18 year–40 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

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

Asyut, Asyut Governorate, 71524, Egypt

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

  • 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.

Treatment and study plan

single intervention by Sirolase ® lower power diode laser 970 ± 15 nm (0.5 watts) continuous emission, power =3 watts, fiber 320 μm

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 the follow-up until 6 months

single intervention by electrosurgical unit which was kept 38 watts rms ± 5%. The working frequency was adjusted to 1.5 MHz ± 5%.

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 then follow-up until 6 months

Primary outcomes

  1. 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.

  2. 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

Sponsors and collaborators

Lead sponsor

Al-Azhar University

Other

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2023
Study completion
2023
First posted
Feb 4, 2025
Registry last updated
Feb 4, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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