NCT01641861 is a NA clinical trial of Papacarie® in Dental Caries, sponsored by Khon Kaen University.

Who is sponsoring NCT01641861?

NCT01641861 is sponsored by Khon Kaen University.

What drugs are being tested in NCT01641861?

Interventions in NCT01641861: Papacarie®, Conventional method.

What condition does NCT01641861 study?

NCT01641861 studies Dental Caries, Secondary Dental Caries, Personal Satisfaction.

Is NCT01641861 still recruiting?

NCT01641861 is currently completed. Last updated 3 February 2016.

Are results published for NCT01641861?

Yes — primary outcome results have been posted to ClinicalTrials.gov. See the outcomes section above for details.

Last reviewed 2016-02-03 · How we verify

NCT01641861

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

Study of Papacarie® for Caries Removal.

Completed NA Results posted Last updated 3 February 2016

What this trial tests

NA trial testing Papacarie® in Dental Caries in 488 participants. Completed in 1 September 2015.

Timeline

1 August 2012

Primary endpoint
1 September 2015

1 September 2015

Quick facts

Lead sponsor	Khon Kaen University
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	single
Primary purpose	treatment
Enrollment	488
Start date	1 August 2012
Primary completion	1 September 2015
Estimated completion	1 September 2015
Sites	1 location across Thailand

Drugs / interventions tested

Papacarie®
Conventional method

Conditions studied

Dental Caries — all drugs for Dental Caries →
Secondary Dental Caries — all drugs for Secondary Dental Caries →
Personal Satisfaction — all drugs for Personal Satisfaction →

Sponsor

Khon Kaen University

Who can join

Adults 7 to 8, any sex, with Dental Caries or Secondary Dental Caries. Healthy volunteers can join.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

Number of Participants With Treatment Failure
Time frame: two years
The dental restorations were evaluated at 6, 12, 18 and 24 months after treatment. Evaluation criteria included the condition of the filling material and presence of secondary caries at the margin of the restorations. The restoration status was re-categorized as a binary outcome: Treatment failure (Yes/No).

Sponsor's own description

The purpose study are to evaluate the efficacy of Papacarie® for caries removal in comparison to the conventional drilling method.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

Efficacy of chemo-mechanical caries removal: a 24-month randomized trial.
Kitsahawong K, Seminario AL, Pungchanchaikul P, Rattanacharoenthum A, et al · · 2024 · cited 3× · PMID 39697785 · DOI 10.3389/froh.2024.1458530

Verify or expand the search:

Other recruiting trials for Dental Caries

Currently open trials in the same condition.

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NCT07431463 — Effects of Different Remineralization Agents on the Progression of Non-Cavitated Approximal Carious Lesions in Primary T · NA · active not recruiting
NCT07134114 — Occlusal Impact of Hall Crowns in Primary Molars · NA · recruiting
NCT07181967 — SDF vs Fluoride Varnish for Streptococcus Mutans Reduction in Children · NA · recruiting

Other Khon Kaen University trials

Trials by the same sponsor.

NCT07494396 — An AI-Based Erythema Measurement System for Psoriasis Lesions · not yet recruiting
NCT07054775 — Comparison of Pruritus Incidence After Intrathecal Morphine 0.1 vs 0.2 mg in Cesarean Section · Phase 4 · recruiting
NCT06994520 — Efficacy of Topical Cannabidiol for Eczema · Phase 2 · active not recruiting
NCT06958029 — Postoperative Atrial Fibrillation in Cardiac Surgery · recruiting
NCT06289257 — Analysis of Vitamin D and VDR Expression in Endometriosis: A Case-Control Study · completed

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT01641861 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Khon Kaen University
Last refreshed: 3 February 2016

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT01641861.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing