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NCT Number: NCT06496828

Clinical Outcomes of Biologically Oriented Preparation Technique

This study aims to evaluate the periodontal response of teeth prepared with a biologically oriented preparation technique (BOPT) compared to conventional preparation for all-ceramic crowns.

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Key information

Age range

19 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Department of Fixed Prosthodontics, University of Damascus Dental School, Damascus, Syria

Damascus, DM20AM18, Syria

Location status: Recruiting

Location contact

Abeer Aljareh, DDS MSc

PRINCIPAL_INVESTIGATOR

Nabil Alhouri, DDS MSc PhD

CONTACT

[email protected]

00963944597722

About this study

The study aims to evaluate the clinical performance of all-ceramic crowns on teeth prepared with two different types of preparations.

This randomized controlled trial will include 60 teeth divided into two groups: 30 teeth will be prepared with BOPT, and 30 teeth will be prepared with shoulder margins. All teeth will receive monolithic or bi-layered ceramic crowns.

Patients are planned to attend follow-up visits after 3, 6, 12, and 18 months, respectively, after cementation. Probing depth, gingival recession, bleeding on probing, gingival index, gingival thickness, patient opinion, and mechanical and biological complications are all recorded at check-up appointments.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Patients older than 18.
  • Two teeth at least needed to be restored with full crowns (each patient needs at least two single crowns).
  • Stable occlusion.
  • Good oral hygiene.
  • Periodontally healthy teeth.
  • Nonsmoking or smoking less than ten cigarettes/day.
  • Probing depth between 1 and 3 mm.

Exclusion criteria

  • Patients younger than 18.
  • Parafunctional habits.
  • Active periodontal disease.
  • Poor oral hygiene.
  • Systemic disease that may affect the periodontal health.
  • Pregnancy.
  • Radiation or chemotherapy.
  • Treatment by Bisphosphonates medication.
  • Patients who are unable or unwilling to attend follow-up visits

Treatment and study plan

Biologically-oriented preparation technique

Procedure

The preparation will be made according to the new principles of biologically oriented technique to receive monolithic and bi-layered all-ceramic crowns.

Conventional method of preparation

Procedure

Teeth prepared with shoulder margins to receive monolithic and bi-layered all-ceramic crowns

Primary outcomes

  1. Change in the Plaque index

    Time frame: Will be recorded at 1 week, 1, 3, 6, 12, and 18 months after cementation of the crowns.

    The plaque index will be measured at the buccal, lingual, mesial, and distal sites of each included tooth, according to Löe and Silness, 1963

  2. Change in the gingival index

    Time frame: Will be recorded at 1 week, 1, 3, 6, 12, and 18 months after cementation of the crowns.

    The gingival index will be measured at the buccal, lingual, mesial, and distal sites of each included tooth according to Silness and Löe, 1964

  3. Change in the probing depth

    Time frame: Will be recorded at 1 week, 1, 3, 6, 12, and 18 months after cementation of the crowns.

    A UNC periodontal probe will be used to measure the probing depth at the buccal, lingual, mesial, and distal sites of each included tooth.

  4. Change in bleeding on probing

    Time frame: Will be recorded at 1 week, 1, 3, 6, 12, and 18 months after cementation of the crowns.

    This variable will be measured at the buccal, lingual, mesial, and distal sites of each included tooth, recorded simultaneously with probing depth, according to Ainamo and Bay, 1975

  5. Change in the gingival marginal stability

    Time frame: Will be recorded at 1 week, 1, 3, 6, 12, and 18 months after cementation of the crowns.

    The gingival marginal stability at the buccal site will be measured using a UNC periodontal probe and a transparent jig to measure the distance between a reference point on the jig and the free gingival margin.

  6. Change in the free gingiva thickness

    Time frame: Will be recorded at 1 week, 1, 3, 6, 12, and 18 months after cementation of the crowns.

    The free gingiva thickness will be measured at the buccal site using a transparent jig with a reference point on the marginal gingiva, a 15-size spreader with a rubber stopper, and a millimetric ruler

Secondary outcomes

  1. Change in the internal and marginal adaptation

    Time frame: Will be recorded at 1 week, 1, 3, 6, 12, and 18 months after cementation.

    The internal and marginal adaptation will be dong using the replica technique. It will be carried out after clinical assessment and cementation of all crowns. An in vitro study utilizing an optical microscope with a micron-graded ruler will be implemented.

  2. Change in the functional and mechanical complications

    Time frame: Will be recorded at 1 week, 1, 3, 6, 12, and 18 months after cementation.

    The functional and mechanical complications will be appraised. The existence of cracks, chipping, and/ or fracture of crowns and their size if exist according to FDI criteria (Hickel et al., 2010) will be evaluated.

  3. Change in the secondary caries status

    Time frame: Will be recorded at 1 week, 1, 3, 6, 12, and 18 months after cementation.

    The secondary caries status will be assessed according to Cvar and Ryge, 2005. The presence or absence of caries at the cervical margins of the abutments will be recorded. Other biological complications, such as abutment fracture, root fracture, and/ or pulpitis will be reported, too

  4. Change in the marginal adaptation after crown cementation

    Time frame: Will be recorded at 1 week, 1, 3, 6, 12, and 18 months after cementation.

    The marginal adaptation after crown cementation will be clinically evaluated using a sharp dental probe, according to Cvar and Ryge, 2005, at each follow-up appointment.

  5. Change in the color matching

    Time frame: Will be recorded at 1 week, 1, 3, 6, 12, and 18 months after cementation.

    The level of color matching will be assessed according to Cvar and Ryge (2005). To measure this outcome, color matching with adjacent teeth, slight mismatching, or major mismatching of color and/or translucency will be reported.

  6. Change in the clinical success

    Time frame: Will be recorded at 1 week, 1, 3, 6, 12, and 18 months after cementation.

    The clinical success status will be assessed according to Walton, 2002. This outcome will be evaluated in case any patient cannot attend the follow-up visits during the trial for any reason. Thus, success might be evaluated indirectly by a phone call if possible.

  7. Change in patients' satisfaction

    Time frame: This will be measured at one week and 18 months following cementation.

    Patients' satisfaction will be assessed according to FDI criteria (Hickel et al., 2010). This outcome will report the level of patient satisfaction functionally and aesthetically. Complete satisfaction, light criticism, major criticism, and entirely dissatisfaction are the levels of the patient's view that will be described.

Study contacts

Contact information is provided by the study sponsor or research team.

Abeer Aljareh, DDS MSc

CONTACT

[email protected]

00963967873566

Nabil Alhouri, DDS MSc PhD

CONTACT

[email protected]

00963944597722

Sponsors and collaborators

Lead sponsor

Damascus University

Other

Registry information

Official study title

Clinical Performance of All-Ceramic Crowns on Teeth Prepared With Biologically Oriented Preparation Technique Compared to Horizontal Preparation

Important dates

Study start
2024
Primary completion
2026
Study completion
2027
First posted
Jul 11, 2024
Registry last updated
Aug 21, 2025

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

View the official ClinicalTrials.gov record (opens in a new tab)

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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