Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05423639
Other study ID # 29301030104462
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date June 1, 2022
Est. completion date July 1, 2022

Study information

Verified date July 2022
Source Cairo University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The aim of this study was evaluating the clinical effectiveness of the hand instrument 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.


Description:

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.


Recruitment information / eligibility

Status Completed
Enrollment 46
Est. completion date July 1, 2022
Est. primary completion date June 30, 2022
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 50 Years
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

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.
optracontact
The instrument is used to achieve large and tight proximal contacts in posterior teeth.

Locations

Country Name City State
Egypt Cairo University Cairo

Sponsors (1)

Lead Sponsor Collaborator
Cairo University

Country where clinical trial is conducted

Egypt, 

Outcome

Type Measure Description Time frame Safety issue
Primary Contact tightness Device used: Dental floss Scoring unit US Public Health Service Clinical Performance Proximal contact Modified USPHS Ryge criteria Proximal contact tightness was measured after 6 months
See also
  Status Clinical Trial Phase
Not yet recruiting NCT04030117 - Class II Restoration Using Bioactive Restorative Material vs Polyacid Modified Composite Resin in Primary Molars N/A
Completed NCT06393270 - 5-year Clinical Follow-up of Restorative Materials
Not yet recruiting NCT06346795 - Class II Restorations With High-Filled Flowable Composites N/A
Completed NCT06120868 - Comparative Clinical Evaluation Between a Novel Self Adhesive and Conventional Bulk-fill Composites N/A
Not yet recruiting NCT05907928 - Radiographic Evaluation of Adaptation of Universal Adhesives N/A
Active, not recruiting NCT06257108 - Clinical Performance of Bulk-Fill Composite Using With Adhesives With or Without Chlorhexidine N/A
Completed NCT06092567 - Post-operative Sensitivity in Composite Restorations N/A
Active, not recruiting NCT06212141 - Comparison of Bulk-Fill Composite Resins in Class II Restorations N/A
Completed NCT04943120 - Clinical Evaluation of "Snow-plow"Technique Versus Bulk Fill Technique in Restorations of Class II Cavities N/A