Direct Pulp Capping Clinical Trial
Official title:
Clinical Evaluation of Direct Pulp Capping in Primary Molars
Verified date | September 2023 |
Source | Mansoura University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The purpose of this study is to Assess the effect of MTA and hard setting Calcium Hydroxide (Dycal) on the clinical and radiographic outcome of direct pulp capping in primary molars and evaluate overall success rate of direct pulp capping in primary molars.
Status | Completed |
Enrollment | 52 |
Est. completion date | June 6, 2023 |
Est. primary completion date | May 27, 2023 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 4 Years to 7 Years |
Eligibility | Inclusion Criteria: - Cooperative child and compliant parent. - Complete physical and mental health. - Children who are known to be healthy and free from systemic diseases. - Primary molars with deep carious lesions leading to pathological exposure but with no signs or symptoms of irreversible pulpitis or necrosis such as spontaneous pain, tenderness to percussion, abscess, fistula, periodontal tissue swelling, or abnormal tooth mobility. Exclusion Criteria: - A deep carious lesion in close proximity to the pulp with an intact lamina dura. - Absence of widening of periodontal membrane space or radiolucency at the furcation and periapical region. - Absence of pulpal calcifications, obliteration of the pulp and root canal, or internal/external root resorption. |
Country | Name | City | State |
---|---|---|---|
Egypt | Outpatient clinic of the Department of Pediatric Dentistry, Faculty of Dentistry- Mansoura University | Mansoura |
Lead Sponsor | Collaborator |
---|---|
Mansoura University |
Egypt,
Caicedo R, Abbott PV, Alongi DJ, Alarcon MY. Clinical, radiographic and histological analysis of the effects of mineral trioxide aggregate used in direct pulp capping and pulpotomies of primary teeth. Aust Dent J. 2006 Dec;51(4):297-305. doi: 10.1111/j.18 — View Citation
de Lourdes Rodrigues Accorinte M, Reis A, Dourado Loguercio A, Cavalcanti de Araujo V, Muench A. Influence of rubber dam isolation on human pulp responses after capping with calcium hydroxide and an adhesive system. Quintessence Int. 2006 Mar;37(3):205-12 — View Citation
Faraco IM Jr, Holland R. Response of the pulp of dogs to capping with mineral trioxide aggregate or a calcium hydroxide cement. Dent Traumatol. 2001 Aug;17(4):163-6. doi: 10.1034/j.1600-9657.2001.170405.x. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | clinical success of direct pulp capping treatment after 3 months follow up | Presence of any of these clinical findings will be considered failure:
pain on mastication or spontaneous pain, as reported by the patient, without clinical evidence of plaque retention around the crown margin denoting bad oral hygiene. pain on percussion on clinical examination . non-physiologic mobility. fistula or sinus tract. |
3 months | |
Primary | clinical success of direct pulp capping treatment after 6 months follow up | Presence of any of these clinical findings will be considered failure:
pain on mastication or spontaneous pain, as reported by the patient, without clinical evidence of plaque retention around the crown margin denoting bad oral hygiene. pain on percussion on clinical examination . non-physiologic mobility. fistula or sinus tract. |
6 months follow up | |
Primary | clinical success of direct pulp capping treatment after 9 months follow up | Presence of any of these clinical findings will be considered failure:
pain on mastication or spontaneous pain, as reported by the patient, without clinical evidence of plaque retention around the crown margin denoting bad oral hygiene. pain on percussion on clinical examination . non-physiologic mobility. fistula or sinus tract. |
9 months follow up | |
Primary | clinical success of direct pulp capping treatment after 12 months follow up | Presence of any of these clinical findings will be considered failure:
pain on mastication or spontaneous pain, as reported by the patient, without clinical evidence of plaque retention around the crown margin denoting bad oral hygiene. pain on percussion on clinical examination . non-physiologic mobility. fistula or sinus tract. |
12 months follow up | |
Primary | radiographic success of direct pulp capping treatment after 3 months follow up | the absence of the following radiographic findings indicate the success of capping material in pulp therapy:
pathological internal or external root resorption. PDL widening. inter-radicular radiolucency formation postoperatively. periapical radiolucency formation postoperatively. |
3 months follow up | |
Primary | radiographic success of direct pulp capping treatment after 6 months follow up | the absence of the following radiographic findings indicate the success of capping material in pulp therapy:
pathological internal or external root resorption. PDL widening. inter-radicular radiolucency formation postoperatively. periapical radiolucency formation postoperatively. |
6 months follow up | |
Primary | radiographic success of direct pulp capping treatment after 9 months follow up | the absence of the following radiographic findings indicate the success of capping material in pulp therapy:
pathological internal or external root resorption. PDL widening. inter-radicular radiolucency formation postoperatively. periapical radiolucency formation postoperatively. |
9 months follow up | |
Primary | radiographic success of direct pulp capping treatment after 12 months follow up | the absence of the following radiographic findings indicate the success of capping material in pulp therapy:
pathological internal or external root resorption. PDL widening. inter-radicular radiolucency formation postoperatively. periapical radiolucency formation postoperatively. |
12 months follow up |
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