The Effect of Functional Crown Lengthening Versus Deep Margin Elevation on Periodontal Tissues

NCT07380126 | Not Yet Recruiting

• 1 other identifier: FDASU-Rec IM022410
• Study Type: interventional
• Target: 20
• Locations: 0 countries
• Sites: N/A

Brief Summary

The present study will evaluate and compare the effect of functional CL and DME in the treatment of posterior teeth with class II caries clinically and on the level of TNF-α in the GCF of treated teeth. Clinical evaluation of periodontal tissue in the form of probing depth as a primary outcome, clinical attachment level, plaque index, bleeding index, gingival index, pink aesthetic score, Radiographic evaluation of biological width and the level of TNF-α in the GCF as a secondary outcome.

Conditions

TNF Alpha

Keywords

Functional Crown lengthening; Deep Margin Elevation; TNF-α

Outcome Measures

Primary Outcomes (1)

• Probing depth

  Will be measured from the gingival margin to the depth of the pocket at four points (mesio-facial, mid-facial, disto-facial and mid-lingual) to the nearest millimeter using UNC-15 periodontal probe. The average of the three facial points will be recorded as the facial probing depth (FPD), while the mid-lingual point will be recorded as the lingual probing depth.

  Clinical measurements preoperative and will be repeated at 1, 3, and 6 months

Secondary Outcomes (1)

• Biochemical evaluation

  Biochemical measurements preoperative and will be repeated at 1, 3 and 6 months

Study Arms (2)

Functional crown lengthening

EXPERIMENTAL

patients will undergo functional crown lengthening by raising a full thickness flap with osseous resection to establish a distance of 3 mm between the cervical margin of the cavity and the bone crest. Osteoplasty was performed in the adjacent and neighboring tooth surfaces to accomplish a smooth bone contour. The flaps will then be sutured in their new position

Procedure: Functional Crown lengthening

Deep Margin Elevation

ACTIVE COMPARATOR

patients will undergo deep margin elevation through a two-step direct restoration performed using the concepts of Progressive Matrixing and Wedging where the Deep subgingival cavity margin will be acquired. Then isolation by rubber dam. A curved matrix will seal the margin without any gingival or rubber dam entrapped in between. One step adhesive system will be performed under rubber dam isolation. Composite resin base is applied to raise the margin by about 2 mm. A bulk fill packable or flowable composite can be used. Finishing will be done using polishing strips and disks. Finally a bitewing radiograph will be taken to check the presence of overhangs or gaps before the final restoration.

Procedure: Deep Margin Elevation

Interventions

Functional Crown lengthening PROCEDURE

patients will undergo functional crown lengthening by raising a full thickness flap with osseous resection to establish a distance of 3 mm between the cervical margin of the cavity and the bone crest. Osteoplasty was performed in the adjacent and neighboring tooth surfaces to accomplish a smooth bone contour. The flaps will then be sutured in their new position

Functional crown lengthening

Deep Margin Elevation PROCEDURE

patients will undergo deep margin elevation through a two-step direct restoration performed using the concepts of Progressive Matrixing and Wedging where the Deep subgingival cavity margin will be acquired. Then isolation by rubber dam. A curved matrix will seal the margin without any gingival or rubber dam entrapped in between. One step adhesive system will be performed under rubber dam isolation. Composite resin base is applied to raise the margin by about 2 mm. A bulk fill packable or flowable composite can be used. Finishing will be done using polishing strips and disks. Finally a bitewing radiograph will be taken to check the presence of overhangs or gaps before the final restoration.

Deep Margin Elevation

Eligibility Criteria

• Age: 20 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Patients aged 20-50 years
• Both genders
• Patients free from any systemic disease that may affect the treatment (Greenberg \& Glick, 2012)
• Patients with intact periodontium
• Patients are ready to comply with oral hygiene measures.
• Patients having Posterior teeth with carious cavities and/ or restorations in need of replacement on proximal surfaces, where the cervical margin of the cavity is at a distance less than 3 mm to the bone crest (Cyana et al.,2013).
• Patients with thick phenotype having gingival thickness \> 1mm (Aimetti et al,2008).
• Patients with keratinized tissue width ≥ 2mm

You may not qualify if:

• Pregnant and lactating females
• Smokers
• Drug abusers.
• Patients with persistent poor oral hygiene
• Patients with proximal margins beyond the bone level
• Patients with developmental dental anomalies
• Patients undergoing or will start orthodontic treatment

Sponsors & Collaborators

• Ain Shams University: lead

Related Publications (2)

• Padbury A Jr, Eber R, Wang HL. Interactions between the gingiva and the margin of restorations. J Clin Periodontol. 2003 May;30(5):379-85. doi: 10.1034/j.1600-051x.2003.01277.x.

  PMID: 12716328 BACKGROUND

• Aimetti M, Massei G, Morra M, Cardesi E, Romano F. Correlation between gingival phenotype and Schneiderian membrane thickness. Int J Oral Maxillofac Implants. 2008 Nov-Dec;23(6):1128-32.

  PMID: 19216284 BACKGROUND

Study Officials

• Doaa A. Khattab, Associate Professor

  Faculty of Dentistry - Ain shams university

  STUDY DIRECTOR

Central Study Contacts

Mahmoud A. Ezz, Bachelor

CONTACT

+201092921800; mahmoudezz210000@gmail.com

Hadeel G. Al Malahy, Associate Professor

CONTACT

+201017767662

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 24, 2026
• First Posted: February 2, 2026
• Study Start: February 1, 2026
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): October 1, 2026
• Last Updated: February 2, 2026

Record last verified: 2026-01