Deep Caries Clinical Trial
Official title:
Evaluation of Post-operative Pain After Vital Pulpotomy of Primary Molars Using Allium Sativum Oil Versus Mineral Trioxide Aggregate (MTA) : (A Pilot Study)
Preservation of the remaining vital portion of curiously exposed pulpal tissue in primary
teeth, was one of the most frequent problems in pediatric dentistry. To solve this problem,
pulpotomy therapy was introduced. Pulpotomy involves amputation of the coronal portion of
affected or infected dental pulp, treatment of the remaining vital radicular pulp tissue
surface should preserve the vitality and function of all or part of the remaining radicular
portion of the pulp. Furthermore, it is an accepted procedure for treating both primary and
permanent teeth with carious pulp exposures, several materials have been using for capping
the radicular pulp after pulpotomy, these included formocresol, glutaraldehyde, ferric
sulfate, and mineral trioxide aggregate.
Allium sativum is one of the most extensively researched medical plants and its antibacterial
activity depends on allicin produced by the enzymatic activity of allinase (a cysteine
sulfoxide lyase). Allicin and other thiosulfinates are believed to be responsible for the
range of therapeutic effects reported for garlic. Garlic extract has been reported to inhibit
growth of various gram‑positive and gram‑negative bacteria. Previous studies showed that A.
sativum oil is used as new pulp medications and it offers a good healing potential, leaving
the remaining pulp tissue healthy and functioning. MTA is a unique material with various
advantages. It has been used successfully by pediatric dentists in a variety of clinical
applications. However, its drawbacks especially its high cost, discoloration potential,
difficulty in handling, and long setting time.
Status | Not yet recruiting |
Enrollment | 30 |
Est. completion date | December 2020 |
Est. primary completion date | September 2020 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 4 Years to 8 Years |
Eligibility |
Inclusion Criteria: 1. Healthy cooperative children with pair of contralateral deep carious mandibular primary molars indicated for vital pulpotomy. 2. In age range from 4 to 8 years. 3. Both sexes are included. 4. Patients with provoked pain. 5. Remaining radicular tissue is vital without suppuration or purulence. 6. With no clinical or radiographic signs of pulp necrosis. 7. Restorable teeth Exclusion Criteria: 1. Excessive haemorrhage that cannot stop by a damp cotton pellet after several minutes 2. With congenital anomalies in teeth e.g., taurodontism, concrescence or fusion. 3- Patients who will show allergic reaction to any material will be used in this trial. 4- Will not be able to stick to follow up protocol in the trial and refuse to give communication data. 5- Patient's guardians refuse to sign up an informed consent before participating in this trial. |
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Cairo University |
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | post- operative Pain ( Spontaneous or on biting): | Pain ( Spontaneous or on biting) using visual analogue scale range from (0 -10) (0) No pain (10) the worst pain condition | 3 months | |
Primary | post-operative pain (spontaneous or on bitting): visual analogue scale | pain (spontaneous or on bitting) using visual analouge scale range from (0 -10) (0) No pain (10) the worst pain condition | at 6 months | |
Primary | post- operative Pain ( Spontaneous or on biting): visual analogue scale | pain (spontaneous or on bitting) using visual analogue scale. range from (0 -10) (0) No pain (10) the worst pain condition | at 9 months | |
Secondary | periapical radiolucency | periapical radiolucency Binary (+/-) DIGORA ® for windows software. |
3 months | |
Secondary | periapical radiolucency | periapical radiolucency Binary (+/-) DIGORA ® for windows software. |
6 months | |
Secondary | periapical radiolucency | periapical radiolucency Binary (+/-) DIGORA ® for windows software. |
at 9 months | |
Secondary | Pathologic internal or external root resorption | DIGORA ® for windows software. Binary (+/-) | 3 months | |
Secondary | Pathologic internal or external root resorption | DIGORA ® for windows software. Binary (+/-) | 6 months | |
Secondary | Pathologic internal or external root resorption | DIGORA ® for windows software. Binary (+/-) | 9 months | |
Secondary | Furcation involvement | DIGORA ® for windows software using furcation failure scores | 3 months | |
Secondary | Furcation involvement | DIGORA ® for windows software using furcation failure scores | 6 months | |
Secondary | Furcation involvement | DIGORA ® for windows software using furcation failure scores | 9 months | |
Secondary | Widening in the periodontal membrane space. DIGORA ® for windows software. Binary (+/-) | DIGORA ® for windows software. Binary (+/-) | 3 months | |
Secondary | Widening in the periodontal membrane space. DIGORA ® for windows software. Binary (+/-) | DIGORA ® for windows software. Binary (+/-) | 6 months | |
Secondary | Widening in the periodontal membrane space. DIGORA ® for windows software. Binary (+/-) | DIGORA ® for windows software. Binary (+/-) | 9 months | |
Secondary | Pain on percussion Back of the mirror: visual analogue scale | Back of the mirror (using visual analogue scale) range from (0 -10) (0) No pain (10) the worst pain condition | 3 months | |
Secondary | Pain on percussion Back of the mirror: visual analogue scale | Back of the mirror (visual analogue scale) range from (0 -10) (0) No pain (10) the worst pain condition | 6 months | |
Secondary | Pain on percussion Back of the mirror: visual analogue scale | Back of the mirror. (visual analogue scale) range from (0 -10) (0) No pain (10) the worst pain condition | 9 months | |
Secondary | Swelling Clinical examination by operator. Binary (+/-) | Clinical examination by operator. Binary (+/-) | 3 months | |
Secondary | Swelling Clinical examination by operator. Binary (+/-) | Clinical examination by operator. Binary (+/-) | 6 months | |
Secondary | Swelling Clinical examination by operator. Binary (+/-) | Clinical examination by operator. Binary (+/-) | 9 months | |
Secondary | Sinus or fistula Clinical examination by operator. Binary (+/-) | Clinical examination by operator. Binary (+/-) | 3 months | |
Secondary | Sinus or fistula Clinical examination by operator. Binary (+/-) | Clinical examination by operator. Binary (+/-) | 6 months | |
Secondary | Sinus or fistula Clinical examination by operator. Binary (+/-) | Clinical examination by operator. Binary (+/-) | 9 months |
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