Completed

NCT Number: NCT07267143

Does a Highly Filled Injectable Resin Composite Work Better Alone or in Combination With a Nanohybride Resin Composite?

This is a double blinded, randomized clinical study that evaluated the performance of a high filled injectable resin composite in polydiastema . The polydiastema disorders will be restored with high filled injectable resin composite (G'aenial Injectable Universal ) or anterior composite resin (G-aenial A'chord ). Restorations will be evaluated after 12 months according to FDI criteria and the data will be analyzed.

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Key information

Conditions

Polydiastema Disorder

Age range

18 year–35 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hacettepe University Faculty of Dentistry

Ankara, 06230, Turkey (Türkiye)

About this study

: The aim of this study was to comparatively evaluate the clinical performance of a high filled injectable resin composite with an anterior composite resin (G-aenial A'chord) in polidaiastemas.

Participants who are 18 years of age or older and healthy, and who have applied to the Restorative Dentistry Department of Hacettepe University Faculty of Dentistry to receive treatment for polidiastema disorders on their front teeth will be included in the study. After explaining the purpose and conditions of the study, they will be asked to sign an informed consent form. The gender, age, and tooth numbers of the participants to be treated will be recorded. 240 upper incisors of 60 patients will be treated, with attention paid to the balanced distribution of teeth in the right and left arches...Data were will be analyzed with Chi- Square, Fisher's Exact Test, Mann U tests

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Polydiastema should be such that the mesial, distal and buccal surfaces of the tooth are included in the restoration.

2. The patient has polydiastema in at least teeth 12, 11, 21 and 22
3. The patient does not have a systemic disease that would prevent restorative treatment.
4. The patient voluntarily signs the informed consent form
5. The patient does not have a physical disability that may prevent him/her from coming for a check-up.
6. The patient does not have a history of spontaneous pain in the teeth to be included.
7. The patient's teeth are alive
8. The patient does not have any periapical pathology in the relevant tooth.
9. The patient's tooth to be included in the study must be in a position to be restored by direct method.
10. The patient is between the ages of 18-35
11. The patient has class 1 and class 2 bite

Exclusion criteria

• 1.Participant must be under 18 years of age or over 35 years of age

2. The participant has poor oral hygiene
3. The participant has systemic disorders that may prevent regular attendance at treatment and control appointments.
4. The participant has parafunctional habits such as clenching/grinding and biting foreign objects.
5. Previous diastema closure or reshaping has been performed on the relevant teeth.
6. Teeth whitening has been performed on the relevant teeth within the last week.
6. Having severe periodontal problems in the relevant tooth
7. The relevant tooth has previously been restored due to caries,
8. The relevant tooth functions as a removable prosthesis support
9. Teeth undergoing orthodontic treatment
10. Finding the participant's breakeven and class 3 closure

Treatment and study plan

Nanohybrid Composite (G-ænial A'Chord, GC Corp., Tokyo, Japan)

Device

Conventional nanohybrid resin composite (G-ænial A'Chord, GC Corp., Tokyo, Japan) was used for direct anterior veneer restorations. The material was applied using a free-hand layering technique following digital smile design and wax-up. A transparent silicone index (Exaclear, GC Corp.) was used for shape guidance when necessary. The enamel surfaces were etched with 37% phosphoric acid and bonded with a universal adhesive (G2 Bond, GC Corp.) before composite application. This intervention represents the standard clinical technique for direct composite veneers and serves as the active comparator group.

Highly Filled Injectable Composite (G-ænial Universal Injectable, GC Corp., Tokyo, Japan)

Device

Highly filled flowable injectable composite resin (G-ænial Universal Injectable, GC Corp., Tokyo, Japan) was used either as a sole restorative material or in combination with a nanohybrid composite for direct anterior veneers. For the injection process, a transparent PVS index (Exaclear, GC Corp.) was fabricated from a wax-up model and used to guide the placement of the material. In the combined technique, a 1-mm palatal layer of nanohybrid composite was placed first, followed by the injection of the flowable composite. The procedure aimed to improve adaptation, minimize voids, and optimize esthetic results compared to the conventional layering method.

Primary outcomes

Functional properties score

Time frame: 1 year

The primary factor for determining the clinical performance of a restorative material is the Functional properties. Visual tactile examination tools will be used for evaluating restorations according to FDI criteria by two experienced researchers at 1- week 6-, 12- months. The functional properties are scored as 1- clinically excellent, 2- clinically good, 3-clinically sufficient/satisfactory, 4-clinically unsatisfactory 5-clinically poor (replacement necesessry). Clinically 1, 2 and 3 scores are clinical acceptable but 4 and 5 scores are designated as failure.

[Time Frame: 1 year]
Esthetic properties score

Time frame: 1 year

The secondary factor for determining the clinical performance of a restorative material is the Esthetic properties. Visual examination will be used for evaluating restorations according to FDI criteria by two experienced researchers at 1- week 6-, 12-months. The Esthetic properties are scored as 1- clinically excellent, 2-clinically good, 3-clinically sufficient/satisfactory, 4-clinically unsatisfactory 5-clinically poor (replacement necesessry). Clinically 1, 2 and 3 scores are clinical acceptable but 4 and 5 scores are designated as failure.

Sponsors and collaborators

Lead sponsor

Tolunay Aytas

Other

Registry information

Official study title

Does a Highly Filled Injectable Resin Composite Work Better Alone or in Combination With a Nanohybride Resin Composite? A Randomised Clinical Trial

Acronym: nanoinjectcomb

Important dates

Study start: 2024
Primary completion: 2024
Study completion: 2025
First posted: Dec 5, 2025
Registry last updated: Dec 5, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.