Deep Margin Elevation in Endodontically Treated Posterior Teeth

NCT07661719 | Active Not Recruiting

• 1 other identifier: KA-25049
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 1

Brief Summary

This study aims to evaluate the periodontal response of proximal surfaces with deep margin elevation (DME) in endodontically treated posterior teeth restored with CAD/CAM systems. Deep subgingival margins present clinical challenges in terms of isolation, restoration, and long-term periodontal health. DME is a minimally invasive technique used to relocate subgingival margins coronally to a supragingival level, facilitating adhesive procedures and CAD/CAM restoration placement. However, the periodontal effects of DME remain unclear. In this prospective split-tooth clinical study, proximal surfaces treated with DME will be compared with control surfaces without DME within the same tooth. The primary outcome will be bleeding on probing (BOP), while secondary outcomes will include probing depth and plaque index. Clinical and radiographic evaluations will be performed at baseline and during follow-up. The results of this study are expected to provide clinical evidence regarding the periodontal impact of DME and support clinical decision-making in the restoration of endodontically treated posterior teeth.

Conditions

Periodontal Health; Endodontically Treated Teeth

Keywords

Deep Margin Elevation; CAD/CAM; Endocrown; Periodontal Response; Split-Mouth Study; DME

Outcome Measures

Primary Outcomes (1)

• Bleeding on Probing (BOP) Positive Surface Proportion

  Gingival inflammation will be assessed by measuring Bleeding on Probing (BOP) using a periodontal probe at six sites per tooth (mesio-buccal, mesio-lingual, mid-buccal, mid-lingual, disto-buccal, and disto-lingual) . The presence of bleeding at any site within the proximal area will be recorded as positive . The proportion of BOP-positive surfaces will be compared between the deep margin elevation (DME) surfaces (experimental group) and the non-DME supragingival surfaces (control group) on the same tooth.

  Baseline (1 week post-treatment), 6 months, and 12 months

Secondary Outcomes (4)

• Changes in Periodontal Pocket Depth (PPD)

  Baseline (1 week post-treatment), 6 months, and 12 months

• Plaque Index (PI) Scores

  Baseline (1 week post-treatment), 6 months, and 12 months

• Gingival Index (GI) Scores

  Baseline (1 week post-treatment), 6 months, and 12 months

• Clinical Performance of CAD/CAM Endocrowns using FDI Criteria

  1 week (Baseline), 6 months, and 12 months post-treatment

Study Arms (2)

Deep Margin Elevation

EXPERIMENTAL

Proximal surfaces treated with deep margin elevation (DME) using a resin composite to relocate subgingival margins to a supragingival level prior to CAD/CAM restoration.

Procedure: Deep Margin Elevation

Control (No DME)

ACTIVE COMPARATOR

Proximal surfaces restored without deep margin elevation, where margins are located at supragingival or equigingival levels.

Procedure: CAD/CAM Restoration Without DME

Interventions

Deep Margin Elevation PROCEDURE

Deep margin elevation (DME) is performed by relocating subgingival proximal margins coronally using a high-filled injectable composite resin following adhesive procedures, prior to CAD/CAM restoration placement.

Deep Margin Elevation

CAD/CAM Restoration Without DME PROCEDURE

Restorative treatment is performed without deep margin elevation, where proximal margins remain at supragingival or equigingival levels and are restored using CAD/CAM systems.

Control (No DME)

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients aged between 18 and 65 years
• Presence of at least one endodontically treated posterior tooth (premolar or molar) with extensive coronal structure loss
• Teeth indicated for indirect CAD/CAM restoration
• Presence of at least one proximal surface requiring deep margin elevation (subgingival margin)
• Opposing proximal surface with supragingival or equigingival margin suitable as control
• Good general health and ability to attend follow-up visits
• Signed informed consent

You may not qualify if:

• Patients with poor oral hygiene or uncontrolled periodontal disease
• Presence of active periodontal disease requiring treatment
• Teeth with mobility greater than Grade I
• Teeth with periapical pathology or unsuccessful endodontic treatment
• Patients with systemic diseases affecting periodontal health (e.g., uncontrolled diabetes)
• Pregnant or lactating women
• Patients using medications affecting gingival tissues (e.g., immunosuppressants, calcium channel blockers)
• Heavy smokers
• Patients unable to comply with follow-up schedule

Sponsors & Collaborators

• Hacettepe University: lead

Study Sites (1)

Hacettepe University, Faculty of Dentistry, Department of Restorative Dentistry

Ankara, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Tooth, Nonvital

Interventions

dimethylethylsilylimidazole

Condition Hierarchy (Ancestors)

Dental Pulp Diseases; Tooth Diseases; Stomatognathic Diseases

Study Officials

• Şükran Bolay, Prof.

  Hacettepe University

  STUDY DIRECTOR

• Büşra Kara Yıldız

  Hacettepe University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Assistant,Principal Investigator

Model Details: This study uses a split-tooth design, where different proximal surfaces of the same tooth receive different interventions. One proximal surface is treated with deep margin elevation (DME), while the opposing surface serves as the control without DME. This design allows direct intra-tooth comparison of periodontal outcomes under identical patient-related conditions.

Study Record Dates

• First Submitted: April 20, 2026
• First Posted: June 22, 2026
• Study Start: March 24, 2026
• Primary Completion (Estimated): October 24, 2026
• Study Completion (Estimated): April 24, 2027
• Last Updated: July 2, 2026

Record last verified: 2026-06

Locations

TU (1)