Assessment of a New Protocol for Indirect Pulp Capping Procedures

NCT03071588 | Unknown DMC

• 1 other identifier: 14/LO/0880
• Study Type: interventional
• Target: 86
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Reversible Pulpitis

Outcome Measures

Primary Outcomes (1)

• cold pulp test (signalling the nerve of the pulp of the tooth by cold application)

  Binary variable outcome measure whether the nerve is positively or negatively responsive to the cold test.

  One year follow up

Study Arms (2)

Control

ACTIVE COMPARATOR

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

Device: Mechanical rotary burs

Conservative

EXPERIMENTAL

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

Device: Carisolv gel

Interventions

Mechanical rotary burs 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.

Control

Carisolv gel 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.

Conservative

Eligibility Criteria

• Age: 16 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• King's College London: lead

Related Publications (2)

• 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.

  PMID: 32854206 DERIVED

• 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.

  PMID: 29738286 DERIVED

Study Officials

• Francesco Mannocci

  King's College London

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Two groups of patients, each group received the investigated intervention at baseline and being followed up in parallel for one year.

Study Record Dates

• First Submitted: February 23, 2017
• First Posted: March 7, 2017
• Study Start: July 1, 2014
• Primary Completion: July 1, 2018
• Study Completion: September 1, 2018
• Last Updated: March 7, 2018

Record last verified: 2018-03

Data Sharing

• IPD Sharing: Will not share