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

Quality of Life Clinical Trial

Official title:

Impact of Minimally Invasive Restorative Techniques on Pregnant Women Oral Health Related Quality of Life: a Randomized Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04619264
• Other study ID #: minimally invasive & OHRQoL
• Status: Completed
• Phase: Phase 2
• Start date: January 10, 2019
• Est. completion date: October 20, 2019

Study information

• Verified date: December 2023
• Source: University of Alexandria
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

A randomized controlled clinical trial was conducted in 2019 and included 162 pregnant women visiting family health centers in Alexandria, Egypt with mild to moderate dental pain due to caries. Participants were randomly assigned into Papacarie-Dup group (n=82) and ART group (n=80). The outcome variable was percent change in OHRQoL measured by OHIP-14.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 162
• Est. completion date: October 20, 2019
• Est. primary completion date: October 1, 2019
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

Inclusion Criteria:

• 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.

Exclusion Criteria:

• Pregnant women with acute pulpitis, swelling or fistula.

• Uncooperative patients and those who refused to participate.

Related Conditions & MeSH terms

• Dental Caries
• Quality of Life

Intervention

Drug:
• Papacarie
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.

Procedure:
• Atraumatic Restorative Treatment
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.

Locations

Country	Name	City	State
Egypt	Family Health Centers	Alexandria

Sponsors (2)

Lead Sponsor	Collaborator
Nourhan M.Aly	Alexandria University

Country where clinical trial is conducted

Egypt, 

References & Publications (7)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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