Infection Clinical Trial
Official title:
Postoperative Pain Following Pulpectomy of Primary Molars With Rotary Instrumentation Versus Manual Instrumentation: A Randomized Clinical Trial
One of the major concerns in pediatric dentistry is premature loss of necrotic primary teeth
which may cause a deleterious effect on the growth of the facial skeletal complex. In order
to sustain the primary tooth as a natural space maintainer, pulpectomy is considered the
treatment of choice.
The essential part of endodontic treatment is to shape and clean the root canal effectively
from infected tissue with microbial reduction, whilst maintaining the original configuration
without creating any procedural errors . Even though, manual instrumentation as used for that
purpose in deciduous teeth, presents some limitation concerning root canal cleaning,
anatomical fidelity and chair-side time.
To achieve successful pulpectomy technique for the primary dentition in a fast and simple
procedure, with short chair time as well as effective debridement of the root canals, rotary
instrumentation is one of the methods recommended over the manual.
Status | Not yet recruiting |
Enrollment | 42 |
Est. completion date | February 2022 |
Est. primary completion date | December 2021 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 4 Years to 6 Years |
Eligibility |
Inclusion Criteria: - Primary posterior teeth requiring pulpectomy. - Cooperative patient in age range from 4 to 6 years - Absence of internal or external pathologic root resorption. - Presence of adequate coronal tooth structure. - Two-thirds of each root remaining. - Parent or guardian agree for participant in the study Exclusion Criteria: - Excessive mobility. - Children lacking cooperative ability. - Children with underlying systemic disease. - Children with special health care needs. |
Country | Name | City | State |
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n/a |
Lead Sponsor | Collaborator |
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Cairo University |
Makarem A, Ravandeh N, Ebrahimi M. Radiographic assessment and chair time of rotary instruments in the pulpectomy of primary second molar teeth: a randomized controlled clinical trial. J Dent Res Dent Clin Dent Prospects. 2014 Spring;8(2):84-9. doi: 10.5681/joddd.2014.015. Epub 2014 Jun 11. — View Citation
Panchal V, Jeevanandan G, Subramanian E. Comparison of instrumentation time and obturation quality between hand K-file, H-files, and rotary Kedo-S in root canal treatment of primary teeth: A randomized controlled trial. J Indian Soc Pedod Prev Dent. 2019 Jan-Mar;37(1):75-79. doi: 10.4103/JISPPD.JISPPD_72_18. — View Citation
Panchal V, Jeevanandan G, Subramanian EMG. Comparison of post-operative pain after root canal instrumentation with hand K-files, H-files and rotary Kedo-S files in primary teeth: a randomised clinical trial. Eur Arch Paediatr Dent. 2019 Mar 12. doi: 10.1007/s40368-019-00429-5. [Epub ahead of print] — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Postoperative pain: modified wong-baker pain rating scale | pain will be assessed using modified wong-baker pain rating scale (0-3),(zero)-no pain; ( one)-slight pain; (two)-moderate pain; and (three)-severe pain. | 12 hours | |
Primary | postoperative pain: modified wong-baker pain rating scale | pain will be assessed using modified wong-baker pain rating scale (0-3),(zero)-no pain; ( one)-slight pain; (two)-moderate pain; and (three)-severe pain. | 24 hours | |
Primary | postoperative pain: modified wong-baker pain rating scale | pain will be assessed using modified wong-baker pain rating scale (0-3),(zero)-no pain; ( one)-slight pain; (two)-moderate pain; and (three)-severe pain. | 48 hours | |
Primary | Postoperative pain: modified wong-baker pain rating scale | pain will be assessed using modified wong-baker pain rating scale (0-3),(zero)-no pain; ( one)-slight pain; (two)-moderate pain; and (three)-severe pain. | 72 hours | |
Secondary | Tenderness to percussion | Percussion test ,Binary (+/-) | Up to 1 year | |
Secondary | Fistula | Visual examination by operator,Binary (+/-) | Up to 1 year | |
Secondary | Instrumentation time | The time spent using both techniques will be measured and compared between the groups. The time will be recorded in minutes using a stopwatch since the beginning of instrumentation until the beginning of restorative procedure. | 15 Minutes | |
Secondary | Furcation or periapical radiolucency | Digital Radiograph ,Binary (+/-) | 6 month | |
Secondary | Furcation or periapical radiolucency | Digital Radiograph ,Binary (+/-) | 12 month |
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