Selective Removal Technique With or Without a Bioactive Material for Deep Caries Lesions

NCT04743219 | Unknown DMC

• 1 other identifier: 0212202023220
• Study Type: interventional
• Target: 104
• Locations: 1 country
• Sites: 1

Brief Summary

Objectives: To evaluate and compare clinical and radiographic success of the selective removal to soft dentine technique in one step using calcium silicate cement (Biodentine) vs. no indirect pulp capping material in patients with deep caries lesions in mature permanent posterior teeth with normal or reversible pulpitis after a 2 year follow-up. Evaluate the integrity of the resin composite restorations using FDI criteria. Material and methods: selective removal to soft dentine in one visit will be performed in 104 blinded patients that will be randomly allocated into 2 study arms, 52 patients will constitute the Biodentine group and 52 the No material group. Clinical examination will be performed to obtain pre-, intra- and postoperative data, including vitality test results, periapical status and risk of caries of the patients. Periapical and bitewing radiographs will be taken before treatment (T-0), at 1 month (T-1), 6 months (T-2), 12 months (T-3) and 24 months (T-4). Restorations will be assessed using the FDI criteria at the same follow up periods.

Conditions

Deep Caries

Outcome Measures

Primary Outcomes (1)

• Clinical success

  Clinical success is defined as healthy pulp, determined by a normal positive not prolonged response in the clinical examination to the cold test and the electrical test, negative response to percussion, absence of symptoms or signs of infection (abscess, fistula, swelling or inflammation) and absence of spontaneous pain.

  2 years

Secondary Outcomes (1)

• Radiographic success

  2 years

Other Outcomes (1)

• Failure composite resin restorations

  2 years

Study Arms (2)

Biodentine Group

ACTIVE COMPARATOR

Biodentine group: patients with mature permanent posterior teeth with deep caries lesions treated with the selective removal technique to soft dentin with Biodentine as indirect pulp capping material before placement of a definitive direct composite resin restoration.

Procedure: Selective removal to soft dentin, Biodentine

No base Group

EXPERIMENTAL

The experimental group or No Base group: patients with mature permanent posterior teeth with deep caries lesions treated with the selective removal technique to soft dentin without the placement of a bioactive material as a base and restored directly with a definitive direct composite resin restoration.

Procedure: Selective removal to soft dentin, No Base

Interventions

Selective removal to soft dentin, Biodentine PROCEDURE

Carious tissue removed until its complete elimination from the lateral walls of the cavity using a round tungsten carbide bur at low speed until consistency of hard dentin around perimeter. With a manual excavator, the central cariogenic biomass will be removed, specifically the superficial part of the necrotic and demineralized caries dentin. In the Biodentine group, Biodentine (Septodont) will be placed on the base of the cavity with a thickness of 2 mm. The last step will be to perform a definitive direct resin restoration according to clinical indication.

Biodentine Group

Selective removal to soft dentin, No Base PROCEDURE

Carious tissue removed until its complete elimination from the lateral walls of the cavity using a round tungsten carbide bur at low speed until consistency of hard dentin around perimeter. With a manual excavator, the central cariogenic biomass will be removed, specifically the superficial part of the necrotic and demineralized caries dentin. In the No base group, no bioactive material will be placed as a liner, the 3M Scothcbonf Universal Plus adhesive will be placed directly over the remaining dentin surface. The last step will be to perform a definitive direct resin restoration according to clinical indication.

No base Group

Eligibility Criteria

• Age: 15 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients older than 15 years.
• Parents or guardians of patients under 18 years of age, but over 15 years of age, and patients over 18 years of age who demonstrate understanding of the study and willingness to participate as evidenced by signing the voluntary informed consent and who receive a signed and dated copy of the informed consent form.
• Occlusal or occlusal-proximal caries lesions, Class I or Class II, in molars or premolars with enamel margins and affecting maximum one proximal wall.
• Molar or premolar with deep caries lesion, involving equal to or greater than two thirds of dentin in depth, with a radiographically identifiable band of healthy dentin separating the pulp chamber roof from the caries lesion.
• Normal response to tests of sensitivity (normal pulp) or discomfort when cold stimulus is applied that disappears in a couple of seconds after the elimination of the stimulus (reversible pulpitits).
• Teeth with negative percussion.

You may not qualify if:

• Patients immunosuppressed or with severe systemic diseases.
• Teeth with root or cervical resorption.
• Teeth with obliteration of the pulp chamber.
• Periapical or furcal radiolucency.
• Patients with periodontal disease.
• Patients with spontaneous acute pain, prolonged excruciating pain and / or pain that disturbs night sleep.
• Patients who have an allergy to any of the materials used in the treatment.
• Patients with caries lesions that during the treatment of their removal a pulp exposure is performed.
• Patients with inadequate initial radiographs for analysis.
• Evidence of pre-cancerous or cancerous lesions.
• Patients who have taken antibiotics in the last two weeks.

Sponsors & Collaborators

• Universidad Rey Juan Carlos: lead

Study Sites (1)

Universidad Rey Juan Carlos

Alcorcón, Madrid, 28922, Spain

RECRUITING

MeSH Terms

Interventions

tricalcium silicate

Study Officials

• Laura Ceballos

  Universidad Rey Juan Carlos

  STUDY DIRECTOR

Central Study Contacts

Patricia Terceño

CONTACT

659053538; ptercenojimenez@gmail.com

Laura Ceballos

CONTACT

667056606; laura.ceballos@urjc.es

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: DDS, MS

Model Details: Randomized clinical trial

Study Record Dates

• First Submitted: February 1, 2021
• First Posted: February 8, 2021
• Study Start: February 1, 2021
• Primary Completion: March 1, 2025
• Study Completion: April 1, 2025
• Last Updated: November 21, 2022

Record last verified: 2022-11

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)