Influence of Lateral Pressure on Sectional Matrix
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ClinicalTrials.gov Identifier: NCT05423639 |
Recruitment Status :
Completed
First Posted : June 21, 2022
Last Update Posted : July 20, 2022
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Condition or disease | Intervention/treatment | Phase |
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Class II Dental Caries | Device: palodent Device: optracontact | Not Applicable |
Dental caries is considered as one of the most prevalent oral infections. Initiation of dental caries is a mufti-factorial process, its risk factors includes high loads of cariogenic bacteria, increased frequency of sugar intake, insufficient exposure to fluoride and reduced salivary flow. Other factors that may influence the occurrence of caries include poor oral hygiene and socio-economic status.
Inter-proximal caries lesions develop between the contacting proximal surfaces of two adjacent teeth. Massive evolution took place in restorative techniques, composite resin materials, cavity designs and armamentarium in the past few decades. As well as drastic solutions for earlier problems of composite resins such as bonding to dentin, wear resistance, postoperative sensitivity and polymerization shrinkage. Despite all the progress noted in that area, still achieving proximal contact tightness in Class II resin composite restorations is considered one of the biggest challenges facing clinicians Proximal contact tightness is a physiological dynamic entity of multifactorial origin that is largely affected by tooth type, location, time of day, patient position, mastication and restorative procedures Failure to obtain proper proximal contact area will influence stability of dental arch and transmission of forces along long axis of teeth during mastication. Traumatic masticatory forces can lead to various problems like; rotation and displacement of the teeth, lifting forces on the teeth, deflective occlusal contacts and food impactions that would result in trauma, pain, inflammation and bleeding of the periodontium. The contact must be neither open nor too tight.
Aim of this study was evaluating the clinical effectiveness of the Optra Contact in conjunction with sectional matrix when applying lateral forces at the contact area during curing to achieve large and tight proximal contacts in posterior teeth.
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 46 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Intervention Model Description: | Randomized Controlled Trial (RCT). |
Masking: | Double (Participant, Outcomes Assessor) |
Primary Purpose: | Treatment |
Official Title: | The Influence of Lateral Pressure on Sectional Matrix in Optimizing Proximal Contact Tightness in Class II Resin Composite Restoration |
Actual Study Start Date : | June 1, 2022 |
Actual Primary Completion Date : | June 30, 2022 |
Actual Study Completion Date : | July 1, 2022 |
Arm | Intervention/treatment |
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Experimental: Control group 1
Testing Palodent sectional matrix system only when placing Class II resin composite restorations is to increase proximal contact tightness.
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Device: palodent
innovative sectional matrix system with Nickel-Titanium rings, anatomically shaped matrix bands and adaptive self-guiding wedges that provides predictable, tight contacts and restorations that accurately replicate the natural tooth anatomy.
Other Name: sectional matrix system |
Active Comparator: Intervention group 2
A pre-contoured instrument called Optra contact (Ivoclar, Vivadent) will be used with group 2. For testing palodent matrix systems with Optracontact when placing Class II resin composite restorations is to increase proximal contact tightness with adjacent teeth when compared with group 1.
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Device: palodent
innovative sectional matrix system with Nickel-Titanium rings, anatomically shaped matrix bands and adaptive self-guiding wedges that provides predictable, tight contacts and restorations that accurately replicate the natural tooth anatomy.
Other Name: sectional matrix system Device: optracontact The instrument is used to achieve large and tight proximal contacts in posterior teeth.
Other Names:
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- Contact tightness Device used: Dental floss Scoring unit US Public Health Service [ Time Frame: Proximal contact tightness was measured after 6 months ]Clinical Performance Proximal contact Modified USPHS Ryge criteria

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Ages Eligible for Study: | 18 Years to 50 Years (Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
- Patients having posterior class II carious lesions were included
- Absence of pain from the tooth to be restored
- Good general health
- Age range:18-50 years
- Fully erupted occluding teeth
Exclusion Criteria:
- Diastema between posterior teeth
- Presence of fixed partial dentures
- Severe periodontal diseases Tooth mobility Non vital teeth

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05423639
Egypt | |
Cairo University | |
Cairo, Egypt, 19019 |
Principal Investigator: | sara SA sayed, master | Cairo University |
Responsible Party: | Sara Salem Sayed Ahmed, Principal investigator, Cairo University |
ClinicalTrials.gov Identifier: | NCT05423639 |
Other Study ID Numbers: |
29301030104462 |
First Posted: | June 21, 2022 Key Record Dates |
Last Update Posted: | July 20, 2022 |
Last Verified: | July 2022 |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
Dental Caries Tooth Demineralization Tooth Diseases Stomatognathic Diseases |