UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000052191 |
|---|---|
| Receipt number | R000059558 |
| Scientific Title | Effect of pain reduction with anesthetic gel injected into periodontal pockets during subgingival scaling and root planing |
| Date of disclosure of the study information | 2023/09/15 |
| Last modified on | 2024/10/02 14:45:37 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
Effect of pain reduction with anesthetic gel injected into periodontal pockets during subgingival scaling and root planing
Acronym
Effect of pain reduction with anesthetic gel injected into periodontal pockets during subgingival scaling and root planing
Scientific Title
Effect of pain reduction with anesthetic gel injected into periodontal pockets during subgingival scaling and root planing
Scientific Title:Acronym
Effect of pain reduction with anesthetic gel injected into periodontal pockets during subgingival scaling and root planing
Region
| Japan |
Condition
Condition
Chronic periodontitis
Classification by specialty
| Dental medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To compare the effect on pain of injectable application of anesthetic gel in periodontal pockets prior to scaling and root planing with that of infiltration anesthesia in patients with periodontal pockets.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Degree of pain immediately after scaling and root planing
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
No need to know
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Application of surface anesthetic gel in periodontal pockets prior to scaling and root planing
Interventions/Control_2
Infiltration anesthesia before scaling and root planing
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 20 | years-old | <= |
Age-upper limit
| 100 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Patients undergoing Basic Periodontal Therapy or Supportive Periodontal Therapy with periodontal pockets of 5 to 9 mm in at least two of the four blocks on the left and right sides of the upper and lower jaws.
Key exclusion criteria
Patients whose physicians deem inappropriate or who have failed to give their consent
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | Masato |
| Middle name | |
| Last name | Minabe |
Organization
Bunkyo Do-ri Dental Clinic
Division name
Department of Dentistry
Zip code
263-0024
Address
2-4-1 Anakawa, Inage-ku, Chiba, Chiba
TEL
+81-43-285-2560
minabe-m@wk9.so-net.ne.jp
Public contact
Name of contact person
| 1st name | Tatsuo |
| Middle name | |
| Last name | Yamamoto |
Organization
Kanagawa Dental University
Division name
Department of Preventive Dentistry and Dental Public Health
Zip code
238-8580
Address
82 Inaoka-cho, Yokosuka, Kanagawa
TEL
+81-46-822-8838
Homepage URL
yamamoto.tatsuo@kdu.ac.jp
Sponsor or person
Institute
Bunkyo Do-ri Dental Clinic
Institute
Department
Personal name
Funding Source
Organization
Bunkyo Do-ri Dental Clinic
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Ethics Committee of Japanese Society of Periodontology
Address
1-43-9 Komagome #401, Toshima-ku, Tokyo
Tel
+81-3-3947-8891
gakkai16@kokuhoken.or.jp
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2023 | Year | 09 | Month | 15 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
https://www.jstage.jst.go.jp/article/perio/66/3/66_105/_article/-char/ja
Number of participants that the trial has enrolled
27
Results
The median VAS score was 20 for gel anesthesia, significantly higher than 5 for infiltration anesthesia (p = 0.002). The VRS mode was 1 for gel anesthesia compared to 0 for infiltration anesthesia, also a significant difference (p = 0.006).
Results date posted
| 2024 | Year | 10 | Month | 02 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
| 2024 | Year | 09 | Month | 30 | Day |
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Main results already published
Date of protocol fixation
| 2022 | Year | 08 | Month | 30 | Day |
Date of IRB
| 2022 | Year | 11 | Month | 07 | Day |
Anticipated trial start date
| 2022 | Year | 11 | Month | 08 | Day |
Last follow-up date
| 2023 | Year | 11 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2023 | Year | 09 | Month | 13 | Day |
Last modified on
| 2024 | Year | 10 | Month | 02 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000059558
