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

NCT ID: NCT06806319

Last Updated: 2025-02-04

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 80 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-10-03
• Study Completion Date: 2023-12-27

Brief Summary

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.

Conditions

Gingival Overgrowth

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

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)

Group Type: ACTIVE_COMPARATOR

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

Intervention Type: 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

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.

Group Type: ACTIVE_COMPARATOR

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

Intervention Type: 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

Interventions

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

Intervention Type: 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

Intervention Type: DEVICE

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 40 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Al-Azhar University

OTHER

Sponsor Role: lead

Responsible Party

Asem Mohammed Kamel Ali

Director

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Asem M lecturer, PhD

Role: PRINCIPAL_INVESTIGATOR

Faculty of Dental Medicine, Al-Azhar University (Assiut branch)

Locations

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

Asyut, Asyut Governorate, Egypt

Countries

Egypt

References

Zeballos BK, Rubina YN, Meza-Mauricio J, Cafferata EA, Vergara-Buenaventura A. Laser gingivectomy for maintaining periodontal health in fixed orthodontic patients: a systematic review. Lasers in Dental Science. 2024 Dec;8(1):1-5.

Reference Type: BACKGROUND

Mehrotra S, Ahuja A, Chowdhary Z, Adhupia KS, Bajaj A, Loitongbam M. Evaluation of the Effect of Diode Laser on Healing after Gingivectomy. Pesquisa Brasileira em Odontopediatria e Clínica Integrada. 2025 Jan 15;25:e230116-.

Reference Type: BACKGROUND

Rakmanee T, Calciolari E, Olsen I, Darbar U, Griffiths GS, Petrie A, Donos N. Expression of growth mediators in the gingival crevicular fluid of patients with aggressive periodontitis undergoing periodontal surgery. Clin Oral Investig. 2019 Aug;23(8):3307-3318. doi: 10.1007/s00784-018-2752-z. Epub 2018 Nov 29.

Reference Type: BACKGROUND

PMID: 30498980 (View on PubMed)

Kuru L, Yilmaz S, Kuru B, Kose KN, Noyan U. Expression of growth factors in the gingival crevice fluid of patients with phenytoin-induced gingival enlargement. Arch Oral Biol. 2004 Nov;49(11):945-50. doi: 10.1016/j.archoralbio.2004.04.010.

Reference Type: BACKGROUND

PMID: 15353252 (View on PubMed)

Guler B, Isler SC, Uraz A, Bozkaya S, Cetiner FD. The comparison of postoperative wound healing following different gingivectomy techniques: A randomized prospective clinical trial.

Reference Type: BACKGROUND

Other Identifiers

crown lengthening and gingiva

Identifier Type: -

Identifier Source: org_study_id