Impact of Minimally Invasive Restorative Techniques on Pregnant Women Oral Health Related Quality of Life

NCT04619264 | Completed Phase 2

• 1 other identifier: minimally invasive & OHRQoL
• Study Type: interventional
• Target: 162
• Locations: 1 country
• Sites: 1

Brief Summary

Aim of the study was to compare the effect of chemo-mechanical caries removal methods using Papacarie-Duo and alternative restorative treatment (ART) on the Oral Health Related Quality of Life (OHRQoL) of pregnant women.

Conditions

Quality of Life; Dental Caries

Keywords

Minimally Invasive Caries Removal; Oral Health Related Quality of Life

Outcome Measures

Primary Outcomes (2)

• Change in Oral Health Related Quality of Life

  This was assessed by measuring changes between the Oral Health Impact Profile-14 (OHIP-14). The OHIP-14 includes 14 questions in seven dimensions with two questions for each dimension: functional limitation, physical pain, psychological discomfort, physical disability, psychological disability, social disability and handicap. Responses to the OHIP-14 items were measured on a 5-pont Likert scale ranging from never = 0; hardly ever = 1; occasionally = 2; fairly often = 3; to very often = 4. The OHIP-14 score is the sum of the scores of the 14 statements and ranges from 0 to 56 and from 0 to 8 for each dimension with higher scores indicating higher frequency of negative impact.

  up to 6 months

• Retention of the final restoration

  The scoring system was as follows: 0=present, without defect; 1=present, small defects on the margin measuring less than 0.5 mm in depth, with no need for repair; 2=present, small defects on the margin measuring 0.5 to 1.0 mm in depth, with need for repair; 3=present, gross defects on the margin measuring 1.0 mm or more in depth, with need for repair; 4=absent, restoration completely lost, need for treatment; 5=absent, other treatment had been performed for some reason; 6=tooth absent for some reason; 7=present, wear on surface less than 0.5 mm, with no need for replacement; 8=present, wear on surface greater than 0.5 mm, with need for replacement; 9=diagnosis impossible. Restorations having a score of 0, 1 or 7 were considered successful and those receiving a score of 2, 3, 4 or 8 were considered failures.

  up to 6 months

Study Arms (2)

Papacarie-Duo

EXPERIMENTAL

Drug: Papacarie

Atraumatic Restorative Treatment

ACTIVE COMPARATOR

Procedure: Atraumatic Restorative Treatment

Interventions

Papacarie DRUG

First, tooth was cleaned with a wet cotton pellet. The gel was inserted using disposable syringe tip into the cavity and its color changed from clear to cloudy indicating the presence of infected tissues. After 40 seconds, the softened carious tissue was removed using excavator by gentle pressure. The remaining gel was removed with a cotton pellet. The procedure was repeated until there was no change in the gel color indicating that there was no more infected tissue.

Also known as: Papacarie-Duo

Papacarie-Duo

Atraumatic Restorative Treatment PROCEDURE

The tooth was cleaned with a wet cotton pellet to remove debris and plaque and then isolated with cotton rolls to promote a dry environment. Caries was removed using a sharp excavator and the cavity was cleaned using a small wet cotton pellet and dried with a dry cotton pellet.

Also known as: ART

Atraumatic Restorative Treatment

Eligibility Criteria

• Age: 18 Years - 45 Years
• Gender Eligibility Details: Pregnant females in the first or second trimester
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Having at least one carious lesion involving dentine with lesion accessible to hand instruments (International Caries Detection and Assessment System score= 5 or 6).
• Suffering from at least mild dental pain as identified by a score of at least 5mm on a Visual Analogue Scale (VAS) 100-mm-long.

You may not qualify if:

• Pregnant women with acute pulpitis, swelling or fistula.
• Uncooperative patients 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 (8)

• Kikwilu EN, Frencken J, Mulder J. Impact of Atraumatic Restorative Treatment (ART) on the treatment profile in pilot government dental clinics in Tanzania. BMC Oral Health. 2009 Jun 8;9:14. doi: 10.1186/1472-6831-9-14.

  PMID: 19505294 BACKGROUND

• Matsumoto SF, Motta LJ, Alfaya TA, Guedes CC, Fernandes KP, Bussadori SK. Assessment of chemomechanical removal of carious lesions using Papacarie Duo: randomized longitudinal clinical trial. Indian J Dent Res. 2013 Jul-Aug;24(4):488-92. doi: 10.4103/0970-9290.118393.

  PMID: 24047844 BACKGROUND

• Musskopf ML, Milanesi FC, Rocha JMD, Fiorini T, Moreira CHC, Susin C, Rosing CK, Weidlich P, Oppermann RV. Oral health related quality of life among pregnant women: a randomized controlled trial. Braz Oral Res. 2018;32:e002. doi: 10.1590/1807-3107bor-2018.vol32.0002. Epub 2018 Jan 22.

  PMID: 29364329 BACKGROUND

• Wewers ME, Lowe NK. A critical review of visual analogue scales in the measurement of clinical phenomena. Res Nurs Health. 1990 Aug;13(4):227-36. doi: 10.1002/nur.4770130405.

  PMID: 2197679 BACKGROUND

• Freitas MCCA, Fagundes TC, Modena KCDS, Cardia GS, Navarro MFL. Randomized clinical trial of encapsulated and hand-mixed glass-ionomer ART restorations: one-year follow-up. J Appl Oral Sci. 2018 Jan 18;26:e20170129. doi: 10.1590/1678-7757-2017-0129.

  PMID: 29364343 BACKGROUND

• Al Habashneh R, Khader YS, Salameh S. Use of the Arabic version of Oral Health Impact Profile-14 to evaluate the impact of periodontal disease on oral health-related quality of life among Jordanian adults. J Oral Sci. 2012 Mar;54(1):113-20. doi: 10.2334/josnusd.54.113.

  PMID: 22466895 BACKGROUND

• Motta LJ, Bussadori SK, Campanelli AP, Silva AL, Alfaya TA, Godoy CH, Navarro MF. Efficacy of Papacarie((R)) in reduction of residual bacteria in deciduous teeth: a randomized, controlled clinical trial. Clinics (Sao Paulo). 2014;69(5):319-22. doi: 10.6061/clinics/2014(05)04.

  PMID: 24838896 BACKGROUND

• Adham MM, El Kashlan MK, Abdelaziz WE, Rashad AS. Comparison of two minimally invasive restorative techniques in improving the oral health-related quality of life of pregnant women: a six months randomized controlled trial. BMC Oral Health. 2021 Apr 30;21(1):221. doi: 10.1186/s12903-021-01581-5.

  PMID: 33931037 DERIVED

MeSH Terms

Conditions

Dental Caries

Interventions

Papacarie; Dental Atraumatic Restorative Treatment

Condition Hierarchy (Ancestors)

Tooth Demineralization; Tooth Diseases; Stomatognathic Diseases

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: November 1, 2020
• First Posted: November 6, 2020
• Study Start: January 10, 2019
• Primary Completion: October 1, 2019
• Study Completion: October 20, 2019
• Last Updated: December 4, 2023

Record last verified: 2023-12

Locations

EG (1)