Clinical Trial Details
— Status: Not yet recruiting
Administrative data
| NCT number |
NCT05928533 |
| Other study ID # |
Nourane Yasser Ali Mohamed |
| Secondary ID |
|
| Status |
Not yet recruiting |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
October 2023 |
| Est. completion date |
October 2024 |
Study information
| Verified date |
June 2023 |
| Source |
Cairo University |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
To evaluate the clinical performance of multifunction Nitric acid etch, mineral enriched
adhesive and flowable resin composite liner versus the universal adhesive in etch and rinse
mode and regular flowable liner in cervical carious anterior cavities.
Description:
The annual failure of composite restoration represents 1 to 5 % with anterior teeth and 1 to3
% with posterior teeth . Many challenges appeared to be the causative factors of this failure
such as the technique sensitivity of its placement, polymerization shrinkage, type and design
of the cavity, location of the tooth, adhesive materials used last but not least operator and
patient related factors. Some of these obstacles can be controllable and others cannot.
According to the systematic review published in 2022, the most common reasons for composite
failure are marginal deterioration which led consequently to secondary caries, marginal
discoloration and post operative hypersensitivity. Restoration of the cervical carious
lesions represents a great challenge to the restorative dentist due to the complicated
clinical situation which include difficult isolation, variation in the tooth substrates and
intraoral biomechanical challenges. Lots of modifications in the resin composite material and
technique of application have been done and they are still ongoing to overcome the
abovementioned inherited shortcomings.
The smear layer is considered as an unstable structure that affects the chemical and
mechanical bonding between the restoration and tooth structure. There are different
techniques to deal with the smear layer, either to remove, modify or dissolve it. Total
removal of this layer with35-37% Phosphoric was the most used technique for preparing the
tooth substrate to receive resin composite restoration. However, postoperative
hypersensitivity was a repeated complaint from the patients. Selective enamel etching
technique was introduced to solve this problem by only applying the phosphoric acid on the
enamel margins and the multimode adhesive incorporating mild acidic monomer will achieve the
dentin conditioning mission. Later, it was concluded that the clinical performance of
multimode adhesives with etch, and rinse mode was better than with self-etch mode.
Furthermore, there is available commercial product introduced to deal with the tooth
substrate in a different way which is the multifunction nitric acid etch. It contains acid
which enable the etching ability and cauterize the minor bleeding, isopropyl alcohol which
acts as an antibacterial agent and cleans the surface before bonding and Hydroxyethyl
methacrylate (HEMA) is a desensitizer which block the dentinal tubules to reduce the
hypersensitivity.
Another concern, which can maximize the performance of the restorative system is the
implementation of the bioactive property in the restorative system. The concept of
bioactivity was achieved by introducing materials which interact with the surrounding tissues
and produce a specific effect in the form of biological response or release of active
substances. This release encourages remineralization and improves health, longevity and
tissue regeneration. The idea of bioactivity was first introduced in dentistry by Larry Hench
in 1960. Furthermore, the bioactive materials have many properties like inhibition of the
bacterial growth by releasing calcium, sodium, silica and phosphate ion and an osteogenic
property due to the use of calcium phosphate or tricalcium phosphate . Many trials were
conducted to study the influence of using the bioactive materials in the restorative
dentistry as the addition of fluoride, calcium phosphate particles and bioactive glass. The
first used bioactive glass in dentistry was 45S5 glass in 1988. It is considered as a rich
source of minerals which plays an important role in tooth remineralization. The
remineralization is considered nowadays the most effective way to compensate the loss in
tooth structure . Giomer is considered one of the most common categories of the bioactive
materials. It relies on the incorporation of the surface pre reacted glass ionomer particles
in its composition. Another category is termed as mineral enriched restorative system which
incorporates bioactive glass in its composition . Such bio constructive materials work in
conjugation with the healing ability of the human body to help in reinforcement of the tooth
substrate. The bioactive glass is calcium sodium phosphosilicate based material which
releases calcium and phosphate, increases the pH and optimizing the conditions for
remineralization. Also, it contains hydrated silica which aids in the formation of
hydroxyapatite like layers on the surface of restoration preventing the penetration of
bacteria and secondary caries development. By adding the bioactive material, the restorative
system will be able to survive for an extended time. Unfortunately, reviewing the literature
revealed absence of any clinical trials that study the performance of multifunction nitric
acid etch and the mineral enriched adhesive and flowable resin composite.
