Comparing the effect of three new materials for the treatment of deep cavities.
- Conditions
- patients with deep dentinal caries
- Registration Number
- CTRI/2018/02/012223
- Lead Sponsor
- Bushra Rahman
- Brief Summary
The fundamental component of operative and endodontic treatment is to maintain the vitality of pulp so as to permit continued odontogenic development. Pulp tissue with its circulation keeps the dentine moist, resilient, and less brittle and also forms reparative dentine.For a badly decayed tooth the discussion as to how much tissue must be removed in order to arrest the caries process is not new. In 1859 John Tomes wrote “it is better that a layer of discolored dentine should be allowed to remain for the protection of the pulp rather than run the risk of sacrificing the tooth.â€
After caries exposure in a primary or permanent tooth, giving the pulp an opportunity to recover from the toxins of dental caries by judiciously removing the infected dentine and isolating the remaining carious lesion (i.e. affected dentine) from oral fluids with a restorative material is now an accepted treatment called as indirect pulp capping. Preserving a layer of affected dentine over pulpal roof protects the pulp from exposure and promotes the formation of tertiary dentine.
Calcium hydroxide since 1928 has been considered the gold standard and the most popular because of beneficial properties such as induction of mineralization, high pH and low cytotoxicity. However some of the limitations reported include poor bonding to dentine, dissolution over time, material reabsorption, mechanically weak, unstable, presence of tunnels in the dentine barrier and the handling properties are less than ideal.
Later MTA introduced by Torabinajed M in 1990 is used as a material of choice for all dentinal defects due to their biocompatibility and ability to induce calcium phosphate precipitate at the interface to periodontium and bone tissue repair, However there exists some drawbacks of this material such as slow setting kinetics and complicated handling properties.
Several new materials are introduced as pulp capping agents with better physical, chemical and biological properties. One such material is Biodentine, known as “dentine in capsuleâ€, “a biocompatible and bioactive dentine substituteâ€. It attracted the attention in the field of dentistry due to fast setting time, high compatibility, high compressive strength, high pH( pH=12),excellent setting ability, and ease of handling as well as its versatile range of chemical applications in endodontics, dental traumatology, restorative dentistry and pediatric dentistry.
One of the recently developed light cure Mineral Trioxide Aggregate material is Theracal LC (Bisco). It is a new, resin-modified calcium silicate filled base/ liner material. The capability of Theracal LC to be cured to a depth of 1.7mm may avoid the risk of untimely dissolution. It has improved seal and bonds to keep the dentin moist. These properties offer major advantage in pulp capping.
Several antibiotics have also been proven beneficial in eradicating the microbial load in endodontics. One among them is combination of Ciprofloxacin, Metronidazole, and Minocycline known as triple antibiotic paste or 3 mix paste. It is capable of eliminating bacterial pathogens from infected dental tissues in both permanent and primary dentitions and provides an excellent outcome in treatment of infected canals.
Statin components are emerging materials in regenerative dentistry. Evidence from both experimental and clinical studies supports the notion of ‘pleiotropic’ effects of statins. They improve osteoblast function and suppress function of osteoclast leading to enhanced bone formation. Therefore, they might improve odontoblastic function resulting in improved dentin formation. Statins are also thought to induce angiogenesis and increase neuronal cell. Consequently, they might have role in pulp regeneration along with dentin regeneration. In addition, sufï¬cient evidence exists in support of the potent antiinflammatory properties of statins. They reduce circulating C-reactive protein (CRP) and pro-inflammatory cytokines levels. Therefore, statins can be considered as an ideal active ingredient in accelerating reparative dentin formation.
Thus the purpose of this study is to evaluate the effect of Biodentine, Thercal LC, and 3 Mixtatin as indirect pulp capping agents in young permanent teeth.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 60
- INCLUSION CRITERIA Clinically: 1.Patients with complete physical and mental wellbeing.
- 2.Permanent premolars and molars with deep dentinal caries.
- 3.Teeth with sensitivity to cold.
- 4.Positive pulp vitality on cold pulp testing Radiographically 1.More than 70% or 2/3rd involvement of dentin thickness 2.Absence of periapical pathology.
- EXCLUSION CRITERIA Clinically: 1.History of spontaneous pain 2.Tenderness on palpation or percussion 3.Pathologic mobility of the tooth 4.
- Swelling of vestibule in relation to the tooth 5.Draining sinus tract in relation to the tooth.
- Radiographically 1.Pathologic external/internal resorption 2.Furcation involvement 3.Calcifications within pulp.
Clinically: •History of spontaneous pain •Tenderness on palpation or percussion •Pathologic mobility of the tooth • Swelling of vestibule in relation to the tooth •Draining sinus tract in relation to the tooth.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 4.Sinus tract RESULT ANALYSIS CRITERIA | Clinical evaluation: Presence of | 1.Sensitivity | 2.Pain | 3.Swelling | 4.Sinus tract | Radiographic evaluation: Presence of | 1.External or internal resorption of tooth | 2.Pulp involvement | 3.PDL widening | 4.Periapical involvement | 5.Young permanent teeth showing absence of root apex development | 6. Pathologic external / internal root resorption 1.External or internal resorption of tooth RESULT ANALYSIS CRITERIA | Clinical evaluation: Presence of | 1.Sensitivity | 2.Pain | 3.Swelling | 4.Sinus tract | Radiographic evaluation: Presence of | 1.External or internal resorption of tooth | 2.Pulp involvement | 3.PDL widening | 4.Periapical involvement | 5.Young permanent teeth showing absence of root apex development | 6. Pathologic external / internal root resorption Radiographic evaluation: Presence of RESULT ANALYSIS CRITERIA | Clinical evaluation: Presence of | 1.Sensitivity | 2.Pain | 3.Swelling | 4.Sinus tract | Radiographic evaluation: Presence of | 1.External or internal resorption of tooth | 2.Pulp involvement | 3.PDL widening | 4.Periapical involvement | 5.Young permanent teeth showing absence of root apex development | 6. Pathologic external / internal root resorption 6. Pathologic external / internal root resorption RESULT ANALYSIS CRITERIA | Clinical evaluation: Presence of | 1.Sensitivity | 2.Pain | 3.Swelling | 4.Sinus tract | Radiographic evaluation: Presence of | 1.External or internal resorption of tooth | 2.Pulp involvement | 3.PDL widening | 4.Periapical involvement | 5.Young permanent teeth showing absence of root apex development | 6. Pathologic external / internal root resorption 4.Periapical involvement RESULT ANALYSIS CRITERIA | Clinical evaluation: Presence of | 1.Sensitivity | 2.Pain | 3.Swelling | 4.Sinus tract | Radiographic evaluation: Presence of | 1.External or internal resorption of tooth | 2.Pulp involvement | 3.PDL widening | 4.Periapical involvement | 5.Young permanent teeth showing absence of root apex development | 6. Pathologic external / internal root resorption 5.Young permanent teeth showing absence of root apex development RESULT ANALYSIS CRITERIA | Clinical evaluation: Presence of | 1.Sensitivity | 2.Pain | 3.Swelling | 4.Sinus tract | Radiographic evaluation: Presence of | 1.External or internal resorption of tooth | 2.Pulp involvement | 3.PDL widening | 4.Periapical involvement | 5.Young permanent teeth showing absence of root apex development | 6. Pathologic external / internal root resorption Clinical evaluation: Presence of RESULT ANALYSIS CRITERIA | Clinical evaluation: Presence of | 1.Sensitivity | 2.Pain | 3.Swelling | 4.Sinus tract | Radiographic evaluation: Presence of | 1.External or internal resorption of tooth | 2.Pulp involvement | 3.PDL widening | 4.Periapical involvement | 5.Young permanent teeth showing absence of root apex development | 6. Pathologic external / internal root resorption 3.Swelling RESULT ANALYSIS CRITERIA | Clinical evaluation: Presence of | 1.Sensitivity | 2.Pain | 3.Swelling | 4.Sinus tract | Radiographic evaluation: Presence of | 1.External or internal resorption of tooth | 2.Pulp involvement | 3.PDL widening | 4.Periapical involvement | 5.Young permanent teeth showing absence of root apex development | 6. Pathologic external / internal root resorption RESULT ANALYSIS CRITERIA RESULT ANALYSIS CRITERIA | Clinical evaluation: Presence of | 1.Sensitivity | 2.Pain | 3.Swelling | 4.Sinus tract | Radiographic evaluation: Presence of | 1.External or internal resorption of tooth | 2.Pulp involvement | 3.PDL widening | 4.Periapical involvement | 5.Young permanent teeth showing absence of root apex development | 6. Pathologic external / internal root resorption 2.Pulp involvement RESULT ANALYSIS CRITERIA | Clinical evaluation: Presence of | 1.Sensitivity | 2.Pain | 3.Swelling | 4.Sinus tract | Radiographic evaluation: Presence of | 1.External or internal resorption of tooth | 2.Pulp involvement | 3.PDL widening | 4.Periapical involvement | 5.Young permanent teeth showing absence of root apex development | 6. Pathologic external / internal root resorption 3.PDL widening RESULT ANALYSIS CRITERIA | Clinical evaluation: Presence of | 1.Sensitivity | 2.Pain | 3.Swelling | 4.Sinus tract | Radiographic evaluation: Presence of | 1.External or internal resorption of tooth | 2.Pulp involvement | 3.PDL widening | 4.Periapical involvement | 5.Young permanent teeth showing absence of root apex development | 6. Pathologic external / internal root resorption 1.Sensitivity RESULT ANALYSIS CRITERIA | Clinical evaluation: Presence of | 1.Sensitivity | 2.Pain | 3.Swelling | 4.Sinus tract | Radiographic evaluation: Presence of | 1.External or internal resorption of tooth | 2.Pulp involvement | 3.PDL widening | 4.Periapical involvement | 5.Young permanent teeth showing absence of root apex development | 6. Pathologic external / internal root resorption 2.Pain RESULT ANALYSIS CRITERIA | Clinical evaluation: Presence of | 1.Sensitivity | 2.Pain | 3.Swelling | 4.Sinus tract | Radiographic evaluation: Presence of | 1.External or internal resorption of tooth | 2.Pulp involvement | 3.PDL widening | 4.Periapical involvement | 5.Young permanent teeth showing absence of root apex development | 6. Pathologic external / internal root resorption
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
i.t.s dental college and hospital, greater noida
🇮🇳Nagar, UTTAR PRADESH, India
i.t.s dental college and hospital, greater noida🇮🇳Nagar, UTTAR PRADESH, IndiaBushra RahmanPrincipal investigator8802135939bushrahmanjmi@gmail.com