Clinical Outcomes of Biologically Oriented Preparation Technique

NCT06496828 | Recruiting DMC

• 1 other identifier: UDDS-Prosthodontics-01-2024
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Crowns; Tooth Preparation

Outcome Measures

Primary Outcomes (6)

• Change in the Plaque index

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

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

• Change in the gingival index

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

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

• Change in the probing depth

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

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

• Change in bleeding on probing

  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

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

• Change in the gingival marginal stability

  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.

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

• Change in the free gingiva thickness

  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

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

Secondary Outcomes (7)

• Change in the internal and marginal adaptation

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

• Change in the functional and mechanical complications

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

• Change in the secondary caries status

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

• Change in the marginal adaptation after crown cementation

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

• Change in the color matching

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

Study Arms (2)

Biologically-oriented preparation technique (BOPT)

EXPERIMENTAL

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

Procedure: Biologically-oriented preparation technique

Conventional preparation

ACTIVE COMPARATOR

Patients in this group will undergo the convention preparation technique.

Procedure: Conventional method of preparation

Interventions

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.

Biologically-oriented preparation technique (BOPT)

Conventional method of preparation PROCEDURE

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

Conventional preparation

Eligibility Criteria

• Age: 19 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Damascus University: lead

Study Sites (1)

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

Damascus, DM20AM18, Syria

RECRUITING

Related Publications (7)

• 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.

  PMID: 37817795 BACKGROUND

• 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.

  PMID: 37253614 BACKGROUND

• 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.

  PMID: 32580920 BACKGROUND

• 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.

  PMID: 34441778 BACKGROUND

• 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.

  PMID: 29513640 BACKGROUND

• 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.

  PMID: 26445857 BACKGROUND

• 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.

  PMID: 23390618 BACKGROUND

Study Officials

• Abeer Aljareh, DDS MSc

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

  PRINCIPAL INVESTIGATOR

• Nabil Alhouri, DDS MSc PhD

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

  STUDY DIRECTOR

• Mohanad Kadhim, DDS MSc PhD

  Department of Periodontology, Faculty of Dentistry, Iraq.

  STUDY DIRECTOR

Central Study Contacts

Abeer Aljareh, DDS MSc

CONTACT

00963967873566; abeer12.jareh@damascusuniversity.edu.sy

Nabil Alhouri, DDS MSc PhD

CONTACT

00963944597722; nabil.alhouri@damascusuniversity.edu.sy

Study Design

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

Study Record Dates

• First Submitted: July 4, 2024
• First Posted: July 11, 2024
• Study Start: April 30, 2024
• Primary Completion (Estimated): December 30, 2026
• Study Completion (Estimated): December 30, 2027
• Last Updated: August 21, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

SY (1)