Assessment of a New Protocol for Indirect Pulp Capping Procedures

NCT ID: NCT03071588

Last Updated: 2018-03-07

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 86 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-07-31
• Study Completion Date: 2018-09-30

Brief Summary

The aim of the study is to assess clinically, radiographically and microbiologically a new protocol for indirect pulp capping procedures compared to the conventional protocol in painful teeth. It was postulated that there is no difference between both protocols in terms clinical, radiographical and microbial outcome measure after one year of follow up in painful teeth.

Detailed Description

Indirect pulp capping is a common dental procedure carried out on painful teeth with deep cavities resulting from dental decay in an attempt to prolong the life of the tooth / pulp while relieving pain, This study aims primarily to assess the response of the pulp of the tooth to two different clinical procedures used in the treatment of deep caries. One group of patients will be treated with a standard clinical procedure which involve mechanical rotary burs with no magnification for caries removal, the other group will be treated with a more conservative clinical procedure using CarisolvTM gel with the aid of an operating microscope for caries removal. The study also involves taking of samples from the tooth decay for microbiological / biochemical analysis and evaluation to determine the species richness in the bacterial community associated with this condition. The study also compare the radiographical findings of 3D cone beam computed tomography (CBCT) scans with that of normal Xrays in detecting the presence of early bone changes associated with the roots of these teeth.

The study carried out at King's College London/ Dental Institute at Guy's Hospital and form part of the routine dental treatment done at the emergency dental clinics with the exception of the CBCT scans. Volunteers given written information about the process and given time to consider participation. Once any questions have been answered, fully informed written consent obtained if they are interested in taking part. At least one deep cavity causing toothache requiring indirect pulp capping detected and diagnosed through conventional clinical and Xray dental assessment. The procedure involves removal of the decay using one of the proposed clinical techniques and the placement of a pulp capping material according to manufacturer's instructions and the definitive filling will be placed, follow up will at 12 months. Radiographic assessment including cone beam computed tomography (CBCT) will be done at baseline and 12 months. It is hoped that data analysed from this study will provide a definitive clinical and radiographic evidence base for the outcome of the indirect pulp capping operative treatment procedure.

Conditions

Reversible Pulpitis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Control

the conventional protocol in indirect pulp capping include the use of mechanical rotary burs for caries removal in teeth with reversible pulpitis.

Group Type: ACTIVE_COMPARATOR

Mechanical rotary burs

Intervention Type: DEVICE

A rotary drill made of steel or diamond impregnated materials attached to a steel shank, available in varying degree of sharpness, lengths and sizes used conventionally in preparation of teeth to receive a dental restoration.

Conservative

the conservative protocol of indirect pulp capping include the use of Carisolv gel for caries removal in teeth with reversible pulpitis.

Group Type: EXPERIMENTAL

Carisolv gel

Intervention Type: DEVICE

A chemical gel made of a combination of amino acids and sodium hypochlorite used with hand instruments to soften and remove the decay to prepare the tooth to receive a dental restoration.

Interventions

Mechanical rotary burs

A rotary drill made of steel or diamond impregnated materials attached to a steel shank, available in varying degree of sharpness, lengths and sizes used conventionally in preparation of teeth to receive a dental restoration.

Intervention Type: DEVICE

Carisolv gel

A chemical gel made of a combination of amino acids and sodium hypochlorite used with hand instruments to soften and remove the decay to prepare the tooth to receive a dental restoration.

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

Clinical diagnosis of reversible pulpitis with positive response to cold pulp test.

Exclusion Criteria

Clinical diagnosis of irreversible pulpitis, Pregnant women, mobile teeth and teeth with tenderness to percussion.

• Minimum Eligible Age: 16 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

King's College London

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Francesco Mannocci

Role: PRINCIPAL_INVESTIGATOR

King's College London

References

Ali AH, Thani FB, Foschi F, Banerjee A, Mannocci F. Self-Limiting versus Rotary Subjective Carious Tissue Removal: A Randomized Controlled Clinical Trial-2-Year Results. J Clin Med. 2020 Aug 25;9(9):2738. doi: 10.3390/jcm9092738.

Reference Type: DERIVED

PMID: 32854206 (View on PubMed)

Ali AH, Koller G, Foschi F, Andiappan M, Bruce KD, Banerjee A, Mannocci F. Self-Limiting versus Conventional Caries Removal: A Randomized Clinical Trial. J Dent Res. 2018 Oct;97(11):1207-1213. doi: 10.1177/0022034518769255. Epub 2018 May 8.

Reference Type: DERIVED

PMID: 29738286 (View on PubMed)

Other Identifiers

14/LO/0880

Identifier Type: -

Identifier Source: org_study_id