Clinical Outcomes of Biologically Oriented Preparation Technique

NCT ID: NCT06496828

Last Updated: 2025-08-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-04-30

Study Completion Date

2027-12-30

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Crowns Tooth Preparation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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Biologically-oriented preparation technique (BOPT)

Patients in this group will undergo the biologically-oriented preparation technique.

Group Type EXPERIMENTAL

Biologically-oriented preparation technique

Intervention Type 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 preparation

Patients in this group will undergo the convention preparation technique.

Group Type ACTIVE_COMPARATOR

Conventional method of preparation

Intervention Type PROCEDURE

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

Interventions

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Biologically-oriented preparation technique

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

Intervention Type PROCEDURE

Conventional method of preparation

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

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

19 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Damascus University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Abeer Aljareh, DDS MSc

Role: PRINCIPAL_INVESTIGATOR

Department of Fixed Prosthodontics, Faculty of Dentistry, Damascus University, Damascus, Syria

Nabil Alhouri, DDS MSc PhD

Role: STUDY_DIRECTOR

Department of Fixed Prosthodontics, Faculty of Dentistry, Damascus University, Damascus, Syria

Mohanad Kadhim, DDS MSc PhD

Role: STUDY_DIRECTOR

Department of Periodontology, Faculty of Dentistry, Iraq.

Locations

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

Damascus, , Syria

Site Status RECRUITING

Countries

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Syria

Central Contacts

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Abeer Aljareh, DDS MSc

Role: CONTACT

00963967873566

Nabil Alhouri, DDS MSc PhD

Role: CONTACT

00963944597722

Facility Contacts

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Nabil Alhouri, DDS MSc PhD

Role: primary

00963944597722

References

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Mohammad A, Abraham S, Nada A. The effect of biologically oriented and subgingival horizontal preparation techniques on periodontal health: A double-blind randomized controlled clinical trial. Saudi Dent J. 2023 Sep;35(6):727-733. doi: 10.1016/j.sdentj.2023.06.003. Epub 2023 Jun 17.

Reference Type BACKGROUND
PMID: 37817795 (View on PubMed)

Palombo D, Rahmati M, Vignoletti F, Sanz-Esporrin J, Salido MP, Haugen HJ, Sanz M. Hard and soft tissue healing around teeth prepared with the biologically oriented preparation technique and restored with provisional crowns: An in vivo experimental investigation. J Clin Periodontol. 2023 Sep;50(9):1217-1238. doi: 10.1111/jcpe.13825. Epub 2023 May 30.

Reference Type BACKGROUND
PMID: 37253614 (View on PubMed)

Agustin-Panadero R, Serra-Pastor B, Loi I, Suarez MJ, Pelaez J, Sola-Ruiz F. Clinical behavior of posterior fixed partial dentures with a biologically oriented preparation technique: A 5-year randomized controlled clinical trial. J Prosthet Dent. 2021 Jun;125(6):870-876. doi: 10.1016/j.prosdent.2020.03.031. Epub 2020 Jun 21.

Reference Type BACKGROUND
PMID: 32580920 (View on PubMed)

Serra-Pastor B, Bustamante-Hernandez N, Fons-Font A, Fernanda Sola-Ruiz M, Revilla-Leon M, Agustin-Panadero R. Periodontal Behavior and Patient Satisfaction of Anterior Teeth Restored with Single Zirconia Crowns Using a Biologically Oriented Preparation Technique: A 6-Year Prospective Clinical Study. J Clin Med. 2021 Aug 6;10(16):3482. doi: 10.3390/jcm10163482.

Reference Type BACKGROUND
PMID: 34441778 (View on PubMed)

Agustin-Panadero R, Serra-Pastor B, Fons-Font A, Sola-Ruiz MF. Prospective Clinical Study of Zirconia Full-coverage Restorations on Teeth Prepared With Biologically Oriented Preparation Technique on Gingival Health: Results After Two-year Follow-up. Oper Dent. 2018 Sep/Oct;43(5):482-487. doi: 10.2341/17-124-C. Epub 2018 Mar 7.

Reference Type BACKGROUND
PMID: 29513640 (View on PubMed)

Paniz G, Nart J, Gobbato L, Chierico A, Lops D, Michalakis K. Periodontal response to two different subgingival restorative margin designs: a 12-month randomized clinical trial. Clin Oral Investig. 2016 Jul;20(6):1243-52. doi: 10.1007/s00784-015-1616-z. Epub 2015 Oct 8.

Reference Type BACKGROUND
PMID: 26445857 (View on PubMed)

Loi I, Di Felice A. Biologically oriented preparation technique (BOPT): a new approach for prosthetic restoration of periodontically healthy teeth. Eur J Esthet Dent. 2013 Spring;8(1):10-23.

Reference Type BACKGROUND
PMID: 23390618 (View on PubMed)

Other Identifiers

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UDDS-Prosthodontics-01-2024

Identifier Type: -

Identifier Source: org_study_id

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