The Impact of Minimally Invasive Restorative Techniques on Dental Pain in Pregnant Women

NCT04573608 | Completed Phase 2

• 1 other identifier: Papacarie vs ART in pregnant
• Study Type: interventional
• Target: 162
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of the present study was to compare the effectiveness of chemo-mechanical caries removal using Papacarie-Duo and Atraumatic Restorative Treatment (ART) in reducing dental pain in pregnant women.

Conditions

Dental Pain; Patient Satisfaction

Keywords

Minimally Invasive Dentistry

Outcome Measures

Primary Outcomes (2)

• Pain assessment

  Difference in pain was measured using Visual Analogue Scale (VAS). The scale is represented by a 100-mm-long horizontal line labeled "no pain" at one end and "worst pain" at the other end. Participants were asked to mark the place on the line representing their level of pain

  up to 6 months

• Satisfaction with treatment

  Satisfaction with treatment was assessed using two questions: the first question was immediately following treatment: "Was the treatment carried out according to your expectations?" The second question was after 6 months" "Has the treatment solved the problem of your teeth?" Each question was answered on a 10-point scale, with lower values indicating a negative perspective and higher values indicating a positive experience.

  up to 6 months

Secondary Outcomes (1)

• Time to remove caries

  Procedure (Immediately while treatment)

Study Arms (2)

Papacarie-Duo

EXPERIMENTAL

Drug: Papacarie

Atraumatic Restorative Treatment

ACTIVE COMPARATOR

Drug: Atraumatic Restorative Treatment

Interventions

Papacarie DRUG

Papacarie was introduced into the cavity using the applicator and left for 40 seconds. A blunt excavator was used to remove the softened dentin. The remaining gel was removed using a cotton pellet. When there was no change in gel color, the cavity was considered caries free. The cavity was then filled with high viscosity glass ionomer cement (GIC) in an encapsulated form (Riva Self-Cure, SDI Limited, Bayswater, VIC, Australia). A mechanical mixer was used to mix the capsule for 10 seconds, the capsule was placed into the applicator to apply the GIC into the cavity. For occluso-proximal cavities, a matrix strip with a wooden wedge was used to provide the appropriate contour of the restoration. A gloved finger was used to apply pressure on the GIC for one minute and occlusion was checked and excess material was removed

Also known as: Papacarie-Duo

Papacarie-Duo

Atraumatic Restorative Treatment DRUG

The tooth was cleaned with a wet cotton pellet to remove debris and plaque. Caries was removed using sharp spoon excavators (Darby-Perry #220/221, #17 DE, Hu-Friedy, Chicago, USA), followed by cleaning the cavity using a small wet cotton pellet and finally dried with a dry cotton pellet. The cavity was considered caries-free when a leather-hard texture was reached and the excavator did not stick anymore. GIC was used to restore the cavity using the same technique described for the other group.

Also known as: ART

Atraumatic Restorative Treatment

Eligibility Criteria

• Age: 20 Years - 35 Years
• Gender Eligibility Details: Pregnant females only
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Pregnant females in the first or second trimester
• Having at least mild dental pain as identified by a score of at least 5mm on a Visual Analogue Scale (VAS) 100-mm-long
• Having at least one carious lesion involving dentine clinically classified as a shallow or medium cavity. This cavity should be accessible to hand instruments (International Caries Detection and Assessment System (ICDAS) score= 5 or 6.

You may not qualify if:

• Pregnant women with acute pulpitis, swelling or fistula.
• Uncooperative patients.
• Patients with severe gingivitis (Gingival Index (GI) score=3).
• Patients who are unable to read and/or write and those who refused to participate.

Sponsors & Collaborators

• Nourhan M.Aly: lead
• Alexandria University: collaborator

Study Sites (1)

Family Health Centers

Alexandria, 21527, Egypt

Location

Related Publications (4)

• Maru VP, Shakuntala BS, Nagarathna C. Caries Removal by Chemomechanical (Carisolv) vs. Rotary Drill: A Systematic Review. Open Dent J. 2015 Dec 31;9:462-72. doi: 10.2174/1874210601509010462. eCollection 2015.

  PMID: 26962375 BACKGROUND

• Gugnani N, Pandit IK, Srivastava N, Gupta M, Sharma M. International Caries Detection and Assessment System (ICDAS): A New Concept. Int J Clin Pediatr Dent. 2011 May-Aug;4(2):93-100. doi: 10.5005/jp-journals-10005-1089. Epub 2010 Apr 15.

  PMID: 27672245 BACKGROUND

• LOE H, SILNESS J. PERIODONTAL DISEASE IN PREGNANCY. I. PREVALENCE AND SEVERITY. Acta Odontol Scand. 1963 Dec;21:533-51. doi: 10.3109/00016356309011240. No abstract available.

  PMID: 14121956 BACKGROUND

• Adham MM, El Kashlan MK, Abdelaziz WE, Rashad AS. The impact of minimally invasive restorative techniques on perception of dental pain among pregnant women: a randomized controlled clinical trial. BMC Oral Health. 2021 Feb 18;21(1):76. doi: 10.1186/s12903-021-01432-3.

  PMID: 33602209 DERIVED

MeSH Terms

Conditions

Toothache; Patient Satisfaction

Interventions

Papacarie; Dental Atraumatic Restorative Treatment

Condition Hierarchy (Ancestors)

Tooth Diseases; Stomatognathic Diseases; Facial Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Treatment Adherence and Compliance; Health Behavior; Behavior

Intervention Hierarchy (Ancestors)

Dentistry

Study Officials

• May M Adham, M.Sc

  Faculty of Dentistry, Alexandria University, Egypt

  PRINCIPAL INVESTIGATOR

• Mona K ElKashlan, PhD

  Faculty of Dentistry, Alexandria University, Egypt

  STUDY DIRECTOR

• Wafaa E Abdelaziz, PhD

  Faculty of Dentistry, Alexandria University, Egypt

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Assistant Lecturer of Dental Public Health

Study Record Dates

• First Submitted: September 27, 2020
• First Posted: October 5, 2020
• Study Start: January 10, 2019
• Primary Completion: October 1, 2019
• Study Completion: October 20, 2019
• Last Updated: October 5, 2020

Record last verified: 2020-10

Locations

EG (1)