The Proximal Contact Tightness and Location in Class II Composite Restorations
Clinical Evaluation of the Proximal Contact Tightness and Location in Class II Composite Restoration Using Different Contact Forming Instruments
1 other identifier
interventional
18
1 country
1
Brief Summary
This study aims to investigate consecutive biological changes in proximal contact tightness using digital force gauge and evaluate proximal contact location using cone beam computed tomography between class II direct composite restorations and adjacent teeth after using sectional matrix system and with different contact forming instruments.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started May 2022
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 24, 2022
CompletedFirst Submitted
Initial submission to the registry
October 24, 2022
CompletedFirst Posted
Study publicly available on registry
March 1, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 30, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
May 30, 2023
CompletedJune 15, 2023
June 1, 2023
1 year
October 24, 2022
June 13, 2023
Conditions
Outcome Measures
Primary Outcomes (1)
Change in proximal contact tightness
Proximal contact tightness (PCT) will be measured using the custom-made contact pressure system that was based on the tooth pressure meter, a device fabricated at the University of Technology, Delft, the Netherlands. (20) The system will use a 0.05-mm-thick metal strip inserted interdentally from An occlusal direction . The metal strip will be connected to the digital force gauge (Mark-10 series 2 digital force gauge). The tightness of the proximal contact will be quantified as the maximum frictional force when the strip will slowly removed in a buccal-lingual direction. The maximum force will be recorded on the screen of the gauge for each measurement when the gauge will be switched to peak-mode
baseline, immediately postoperative, 1 month, 3 month, 9 month, and 12 month
Secondary Outcomes (1)
Change in proximal contact location
baseline and immediately postoperative
Study Arms (4)
Palodent® plus sectional matrix system "Control group"
ACTIVE COMPARATORPerForm™ "Experimental"
EXPERIMENTALTrimax™ "Experimental"
EXPERIMENTALContact Pro™ "Experimental"
EXPERIMENTALInterventions
All teeth will be treated with (Palodent ® plus sectional matrix system) (sectional matrix, biting ring, plastic diamond wedge)
Treated with (PerForm™) as Contact Forming Instrument with (Palodent ® plus sectional matrix system)
Treated with (AdDent Trimax™) as Contact Forming Instrument with (Palodent ® plus sectional matrix system)
Treated with (Contact Pro™) as Contact Forming Instrument with (Palodent ® plus sectional matrix system)
Eligibility Criteria
You may qualify if:
- Presence of proximal caries in CBCT x-ray with score 3 to 4 according to the radiographic International Caries Detection and Assessment System (ICDAS).
- Presence of the antagonist and the adjacent tooth making contact.
- The teeth to be restored had to show no signs of pulpitis but positive sensitivity using endo ice testing.
- Size of the isthmus with no more than 2/3 of the intercuspal distance
- Good oral health and absence of periodontal disease
- Patients who are not suffering from severe systemic diseases or allergies
You may not qualify if:
- Medically compromised patients
- Clinical signs of bruxism, traumatic malocclusion
- Pregnant or breast feeding at the time of restoration placement
- Intolerance or allergy toward the applied restorative materials
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- karim mohamedlead
Study Sites (1)
Karim Mohamed Wahba Abbass
Alexandria, 00000, Egypt
Related Publications (1)
Abbassy KM, Elmahy WA, Holiel AA. Evaluation of the proximal contact tightness in class II resin composite restorations using different contact forming instruments: a 1-year randomized controlled clinical trial. BMC Oral Health. 2023 Oct 7;23(1):729. doi: 10.1186/s12903-023-03462-5.
PMID: 37805456DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, OUTCOMES ASSESSOR
- Masking Details
- Each case will be represented by a code and the group name. These will be sealed in a sequentially numbered opaque envelope and the set of envelopes will be given to the senior supervisor. When the investigator wants to enroll a new case, he will notify the supervisor who will take the next inline envelope and will write the name of the participant on it. At the time of intervention implementation, the investigator will open the sealed envelope and retrieve the allocation and apply.
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Clinical instructor at faculty of dentistry Alexandria university
Study Record Dates
First Submitted
October 24, 2022
First Posted
March 1, 2023
Study Start
May 24, 2022
Primary Completion
May 30, 2023
Study Completion
May 30, 2023
Last Updated
June 15, 2023
Record last verified: 2023-06
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE