Skip to content

Comparing proximal contact of direct and in-direct restorations for reconstruction of endodontically treated teeth: Randomized Clinical Trial

Comparing proximal contact of direct and in-direct restorations for reconstruction of endodontically treated teeth: Randomized Clinical Trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
IRCT
Registry ID
IRCT20230311057684N1
Enrollment
40
Registered
2023-03-15
Start date
2023-04-20
Completion date
Unknown
Last updated
2023-04-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Carious teeth in need of root treatment and crown restoration. Disease of hard tissues of teeth, unspecified

Interventions

Intervention 1: Intervention group: Performing direct restoration: one week after the root treatment, the patient will return for restoration. First, the fragile and unsupported structure of the tooth

Sponsors

Shahed University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
12 Years to 70 Years

Inclusion criteria

Inclusion criteria: Patients between the ages of 12 and 70 years Patients with permanent dentition A patient with good oral health Patients with normal occlusion The patient has at least one root-treated tooth (first or second molar, first or second premolar of the maxilla or mandible) in need of crown restoration. At least one of the mesial or distal surfaces of the tooth is completely missing and the contact with the adjacent tooth is completely open The adjacent tooth should be available for gaining proximal contact In the root treated tooth, at least two healthy tooth walls are left after removing the weak or decayed tooth structure Have received good quality root canal treatment The patient has signed the written consent form

Exclusion criteria

Exclusion criteria: Having any severe systemic disease or allergy or intraoral lesions A patient who has periodontal diseases and has lost a lot of periodontal structure (more than 40%) A patient with parafunction or bruxism A patient who has uncontrollable gum bleeding after probing Treated tooth or the tooth adjacent to it has a pathological mobility (grade = 1) The patient is a pregnant or a lactating woman The patient has a mental or physical disability The patient has untreated disorders of the jaw joint

Design outcomes

Primary

MeasureTime frame
Proximal contact tightness between the tooth receiving the restoration and the adjacent teeth. Timepoint: Immediately after completing the dental crown restoration. Method of measurement: In order to evaluate the proximal contact, three dentists involved in this study were fully trained and their opinion compliance with the preliminary study (Pilot Study) was checked. (kappa coefficient equal to 0.86 is considered based on statistical test). In order to evaluate the PCT with the adjacent tooth in this study, we will first place the patient's chair (dental unit) in a position where his head is at an angle of 45 degrees with the horizon and he is asked to rest his head completely on the chair. Then the following two methods are used for this evaluation: 1. VAS test (Visual Analogue Scale): For this purpose, dental floss with handles (Ever clean dental floss picks, Iran) will be used and after the floss passes through from Occlusal to gingival, PCT will be recorded as a number from 0 to 10 in VAS format. It should be noted that VAS is a standard visual ruler that can be used in various stuations to rank many variables that cannot be reported numerically and especially in cases that depend on the feelings of the person testing or being tested. 2. Dynamometer test: In order to quantify the PCT, a dynamometer device is used on the order of researchers and made by mechanical science experts. This force measuring device has a sensor sensitive to the application of force (Force sensing resistor, Tekscan co.) with an accuracy of one hundredth of a newton, and a piece designed and connected to the head probe in such a way that a dental floss with a handle can be fixed in this piece. At the same time as the thread passes from the occlusal to the gingival side of the proximal contact area, the force graph is drawn according to time (coded using Arduino micro controller) and the maximum force will be recorded as the force necessary to pass the floss from the proximal contact. In

Secondary

MeasureTime frame
Restoration contour in a way that it does not cause gingivitis. Timepoint: After receiving direct or indirect restoration. Method of measurement: Checking the contour via parallel radiography.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactSepideh Behzadi

Shahed University

behzadisepide@yahoo.com+98 21 8895 9210

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026