CrownsNCT06496828
Clinical Outcomes of Biologically Oriented Preparation Technique
A study testing Biologically-oriented preparation technique and Conventional method of preparation in people with Crowns and Tooth Preparation, run by Damascus University at 1 site in Syria.
Trial 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. Read more about this study
- Who is it for?
- Ages 19 to 80 years
- Conditions the study is for
- Crowns, Tooth Preparation
- What is being tested?
- Biologically-oriented preparation technique and Conventional method of preparation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteSyria
- Study dates
- 30 Apr 2024to 30 Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Patients younger than 18.
- Parafunctional habits.
- Active periodontal disease.
- Poor oral hygiene.
- Systemic disease that may affect the periodontal health.
- Pregnancy.
Show all 9Show fewer
- Radiation or chemotherapy.
- Treatment by Bisphosphonates medication.
- Patients who are unable or unwilling to attend follow-up visits
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Syria1 site, 1 recruiting
- Recruiting
Department of Fixed Prosthodontics, University of Damascus Dental School, Damascus, Syria
Damascus, DM20AM18
Nabil Alhouri, DDS MSc PhD, 00963944597722, nabil.alhouri@damascusuniversity.edu.sy
Abeer Aljareh, DDS MSc
About this study
Official title: Clinical Performance of All-Ceramic Crowns on Teeth Prepared With Biologically Oriented Preparation Technique Compared to Horizontal Preparation
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.
Read the detailed description
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
- Crowns, Tooth Preparation
- Being tested
- Biologically-oriented preparation technique, Conventional method of preparation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Biologically-oriented preparation techniqueProcedure or surgery
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 preparationProcedure or surgery
Teeth prepared with shoulder margins to receive monolithic and bi-layered all-ceramic crowns
| Study group | Role | What they receive |
|---|---|---|
| Biologically-oriented preparation technique (BOPT) | Experimental | Patients in this group will undergo the biologically-oriented preparation technique. Receives: Procedure: Biologically-oriented preparation technique |
| Conventional preparation | Active comparator | Patients in this group will undergo the convention preparation technique. Receives: Procedure: Conventional method of preparation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 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.
Measured: 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
Measured: 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.
Measured: 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
Measured: 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
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.
Measured: Will be recorded at 1 week, 1, 3, 6, 12, and 18 months after cementation.
Change in the functional and mechanical complications
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.
Measured: Will be recorded at 1 week, 1, 3, 6, 12, and 18 months after cementation.
Change in the secondary caries status
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
Measured: Will be recorded at 1 week, 1, 3, 6, 12, and 18 months after cementation.
Change in the marginal adaptation after crown 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.
Measured: Will be recorded at 1 week, 1, 3, 6, 12, and 18 months after cementation.
Change in the color matching
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.
Measured: Will be recorded at 1 week, 1, 3, 6, 12, and 18 months after cementation.
Change in the clinical success
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.
Measured: Will be recorded at 1 week, 1, 3, 6, 12, and 18 months after cementation.
Change in patients' satisfaction
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.
Measured: This will be measured at one week and 18 months following cementation.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jul 2024
- Study start30 Apr 2024
- Primary completion30 Dec 2026 (estimated)
- Study completion30 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for CrownsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Damascus University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Abeer Aljareh, DDS MSc, Principal investigator, Department of Fixed Prosthodontics, Faculty of Dentistry, Damascus University, Damascus, SyriaNabil Alhouri, DDS MSc PhD, Study director, Department of Fixed Prosthodontics, Faculty of Dentistry, Damascus University, Damascus, SyriaMohanad Kadhim, DDS MSc PhD, Study director, Department of Periodontology, Faculty of Dentistry, Iraq.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06496828
- Sponsor's protocol ID
- UDDS-Prosthodontics-01-2024
- Status last verified
- Aug 2026
- First submitted
- 4 Jul 2024
- Last updated
- 1 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 37817795Palombo 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.
PubMed 37253614Agustin-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.
PubMed 32580920Serra-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.
PubMed 34441778Agustin-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.
PubMed 29513640Paniz 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.
PubMed 26445857Loi 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.
PubMed 23390618
Study at a glance
From the registry record, last updated by the sponsor on 1 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Performance of All-Ceramic Crowns on Teeth Prepared With Biologically Oriented Preparation Technique Compared to Horizontal Preparation
- ClinicalTrials.gov ID
- NCT06496828
- Acronym / sponsor ID
- UDDS-Prosthodontics-01-2024
- Conditions
- Crowns, Tooth Preparation
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Damascus UniversityUniversity, hospital or other
- Study start
- 30 Apr 2024 (actual)
- Primary completion
- 30 Dec 2026 (estimated)
- Study completion
- 30 Dec 2027 (estimated)
- First posted
- 11 Jul 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Biologically-oriented preparation technique (BOPT) | Experimental | Procedure: Biologically-oriented preparation techniquePatients in this group will undergo the biologically-oriented preparation technique. |
| Conventional preparation | Active comparator | Procedure: Conventional method of preparationPatients in this group will undergo the convention preparation technique. |
Who may qualify
- Ages
- 19 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (9 listed)
- Patients younger than 18.
- Parafunctional habits.
- Active periodontal disease.
- Poor oral hygiene.
- Systemic disease that may affect the periodontal health.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Biologically-oriented preparation techniqueThe preparation will be made according to the new principles of biologically oriented technique to receive monolithic and bi-layered all-ceramic crowns. | Procedure or surgery | Biologically-oriented preparation technique (BOPT) |
| Conventional method of preparationTeeth prepared with shoulder margins to receive monolithic and bi-layered all-ceramic crowns | Procedure or surgery | Conventional preparation |
Primary outcome
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
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
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.
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
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.
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
7 secondary outcomes
Change in the internal and marginal adaptation
Time frame: Will be recorded at 1 week, 1, 3, 6, 12, and 18 months after cementation.
Change in the functional and mechanical complications
Time frame: Will be recorded at 1 week, 1, 3, 6, 12, and 18 months after cementation.
Change in the secondary caries status
Time frame: Will be recorded at 1 week, 1, 3, 6, 12, and 18 months after cementation.
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.
Change in the color matching
Time frame: Will be recorded at 1 week, 1, 3, 6, 12, and 18 months after cementation.
Change in the clinical success
Time frame: Will be recorded at 1 week, 1, 3, 6, 12, and 18 months after cementation.
Change in patients' satisfaction
Time frame: This will be measured at one week and 18 months following cementation.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Sep 2026.
- Background: PubMed 37817795Mohammad 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.
- Background: PubMed 37253614Palombo 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.
- Background: PubMed 32580920Agustin-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.
- Background: PubMed 34441778Serra-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.
- Background: PubMed 29513640Agustin-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.
- Background: PubMed 26445857Paniz 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.
- Background: PubMed 23390618Loi 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Abeer Aljareh, DDS MSc principal investigator
Department of Fixed Prosthodontics, Faculty of Dentistry, Damascus University, Damascus, Syria
Nabil Alhouri, DDS MSc PhD study director
Department of Fixed Prosthodontics, Faculty of Dentistry, Damascus University, Damascus, Syria
Mohanad Kadhim, DDS MSc PhD study director
Department of Periodontology, Faculty of Dentistry, Iraq.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Biologically-oriented preparation technique and Conventional method of preparation in people with Crowns and Tooth Preparation, run by Damascus University at 1 site in Syria.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 1 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Syria. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Abeer Aljareh, DDS MSc (00963967873566, abeer12.jareh@damascusuniversity.edu.sy), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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 study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06496828, which also lists 7 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Sep 2026.