Dental PainPhase 2NCT04573608
The Impact of Minimally Invasive Restorative Techniques on Dental Pain in Pregnant Women
A Phase 2 study testing Papacarie and Atraumatic Restorative Treatment in people with Dental Pain and Patient Satisfaction, run by Nourhan M.Aly at 1 site in Egypt.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 to 35 years, women only
- Conditions the study is for
- Dental Pain, Patient Satisfaction
- What is being tested?
- Papacarie and Atraumatic Restorative Treatment
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 162 participants
- Where
- 1 siteEgypt
- Study dates
- 10 Jan 2019to 20 Oct 2019
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 35 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Impact of Minimally Invasive Restorative Techniques on Dental Pain in Pregnant Women: a Randomized Clinical Trial
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.
Read the detailed description
A randomized controlled clinical trial was conducted in 2019 and included 162 pregnant women visiting family health centers in Alexandria, Egypt with dental pain due to caries not extending to pulp who were randomly assigned into Papacarie-Duo group (n=82) and ART group (n=80) after stratification by number of treated surfaces
- Conditions
- Dental Pain, Patient Satisfaction
- Being tested
- Papacarie, Atraumatic Restorative Treatment
- Keywords
- Minimally Invasive Dentistry
- Medical subject headings
- Toothache, Patient Satisfaction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PapacarieDrug
Also called Papacarie-Duo
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
Atraumatic Restorative TreatmentDrug
Also called ART
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.
| Study group | Role | What they receive |
|---|---|---|
| Papacarie-Duo | Experimental | Not described Receives: Drug: Papacarie |
| Atraumatic Restorative Treatment | Active comparator | Not described Receives: Drug: Atraumatic Restorative Treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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.
Measured: up to 6 months
Secondary outcomes (1)
Time to remove caries
Time to remove caries was recorded using a stop watch.
Measured: Procedure (Immediately while treatment)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Oct 2020
- Study start10 Jan 2019
- Primary completion1 Oct 2019
- Study completion20 Oct 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Dental PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 162 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nourhan M.Aly
- Sponsor type
- University, hospital or other
- Collaborators
- Alexandria University
- Responsible party
- Sponsor-investigator, Nourhan M.Aly, University of Alexandria
- Investigators
- May M Adham, M.Sc, Principal investigator, Faculty of Dentistry, Alexandria University, EgyptMona K ElKashlan, PhD, Study director, Faculty of Dentistry, Alexandria University, EgyptWafaa E Abdelaziz, PhD, Study director, Faculty of Dentistry, Alexandria University, Egypt
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04573608
- Sponsor's protocol ID
- Papacarie vs ART in pregnant
- Status last verified
- Oct 2020
- First submitted
- 27 Sep 2020
- Last updated
- 5 Oct 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 26962375Gugnani 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.
PubMed 27672245LOE 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.
PubMed 14121956Adham 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.
PubMed 33602209
Study at a glance
From the registry record, last updated by the sponsor on 5 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of Minimally Invasive Restorative Techniques on Dental Pain in Pregnant Women: a Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT04573608
- Acronym / sponsor ID
- Papacarie vs ART in pregnant
- Conditions
- Dental Pain, Patient Satisfaction
- Keywords
- Minimally Invasive Dentistry
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 162 participants (actual)
- Lead sponsor
- Nourhan M.AlyUniversity, hospital or other
- Collaborators
- Alexandria University
- Study start
- 10 Jan 2019 (actual)
- Primary completion
- 1 Oct 2019 (actual)
- Study completion
- 20 Oct 2019 (actual)
- First posted
- 5 Oct 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
A randomized controlled clinical trial was conducted in 2019 and included 162 pregnant women visiting family health centers in Alexandria, Egypt with dental pain due to caries not extending to pulp who were randomly assigned into Papacarie-Duo group (n=82) and ART group (n=80) after stratification by number of treated surfaces
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Papacarie-Duo | Experimental | Drug: Papacarie |
| Atraumatic Restorative Treatment | Active comparator | Drug: Atraumatic Restorative Treatment |
Who may qualify
- Ages
- 20 to 35 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PapacarieAlso: Papacarie-DuoPapacarie 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 | Drug | Papacarie-Duo |
| Atraumatic Restorative TreatmentAlso: ARTThe 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. | Drug | Atraumatic Restorative Treatment |
Primary outcome
Pain assessment
Time frame: up to 6 months
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
Satisfaction with treatment
Time frame: up to 6 months
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.
1 secondary outcome
Time to remove caries
Time frame: Procedure (Immediately while treatment)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Oct 2020.
- Background: PubMed 26962375Maru 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.
- Background: PubMed 27672245Gugnani 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.
- Background: PubMed 14121956LOE 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.
- Derived from this study: PubMed 33602209Adham 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
May M Adham, M.Sc principal investigator
Faculty of Dentistry, Alexandria University, Egypt
Mona K ElKashlan, PhD study director
Faculty of Dentistry, Alexandria University, Egypt
Wafaa E Abdelaziz, PhD study director
Faculty of Dentistry, Alexandria University, Egypt
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Papacarie and Atraumatic Restorative Treatment in people with Dental Pain and Patient Satisfaction, run by Nourhan M.Aly at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Oct 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain assessment (time frame: up to 6 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04573608, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Oct 2020.