UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000043357 |
|---|---|
| Receipt number | R000049498 |
| Scientific Title | The Effectiveness of Chlorhexidine Gel on Early Wound Healing after Tooth Extraction : A Randomized-Controlled Trial |
| Date of disclosure of the study information | 2021/06/01 |
| Last modified on | 2022/11/24 07:42:02 |
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Basic information
Public title
The Effect of 0.2% Chlorhexidine Gel on Wound Healing after Tooth Extraction
Acronym
CHX gel and Post-extraction Wound
Scientific Title
The Effectiveness of Chlorhexidine Gel on Early Wound Healing after Tooth Extraction : A Randomized-Controlled Trial
Scientific Title:Acronym
The Effectiveness of Chlorhexidine Gel on Early Wound Healing after Tooth Extraction : A Randomized-Controlled Trial:CHX gel and Post-extraction Wound
Region
| Asia(except Japan) |
Condition
Condition
Adult, non-smoker, healthy subjects
Classification by specialty
| Dental medicine | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The objective of the study is to evaluate the effect of 0.2% chlorhexidine gel in early wound healing after tooth extraction
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
Wound diameter, assessed immediately after extraction and 7 days after procedure, in bucco-lingual and mesio-lingual width
Key secondary outcomes
Healing, assessed using the standardized index by Landry, Turnbull and Howley (1988).
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -investigator(s) and assessor(s) are blinded
Control
Placebo
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Intervention: receive topical administration of chlorhexidine digluconate 0.2% (Perio-kin, LaboratoriosKin S.A., Barcelona, Spain)immediately after tooth extraction and 500 mg of mefenamic acid
Interventions/Control_2
Control : receive topical administration of placebo (na-cmc, glyserin and aquadest) immediately after tooth extraction and 500 mg of mefenamic acid
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
| 18 | years-old | <= |
Age-upper limit
| 40 | years-old | > |
Gender
Male and Female
Key inclusion criteria
(i) patients who undergo tooth extraction of mandibular first molar,
(ii) aged 18-40 years with American Society of Anesthesiologists physical status I,
(iii) do not have the medical history of being allergic to chlorhexidine and mefenamic acid,
(iv) is not consuming any other antibiotic, analgesic or anti-inflammation drug(s) at least 7 days prior to the procedure,(v) lack of infection at the tooth indicated for extraction 3 days prior to the extraction procedure,
(vi) absence of any pathology at the areaof the tooth indicated for extraction and neighboring teeth.
Key exclusion criteria
(i)medically compromised condition,
(ii)being pregnant,
(iii)with tooth requires surgical extraction were excluded from the study.
Target sample size
32
Research contact person
Name of lead principal investigator
| 1st name | Amaliya |
| Middle name | |
| Last name | Amaliya |
Organization
Dental Faculty-Universitas Padjadjaran-Indonesia
Division name
Periodontology
Zip code
40132
Address
Jalan Sekeloa Selatan no. 1 Bandung - West Java
TEL
0062222504985
amaliya@fkg.unpad.ac.id
Public contact
Name of contact person
| 1st name | Amaliya |
| Middle name | |
| Last name | Amaliya |
Organization
Dental Faculty - Universitas Padjadjaran - Indonesia
Division name
Periodontology
Zip code
40132
Address
Jalan Sekeloa Selatan no. 1 Bandung 40132 - West Java
TEL
0062222504985
Homepage URL
amaliya@fkg.unpad.ac.id
Sponsor or person
Institute
Dental Faculty - Department of Periodontology - Universitas Padjadjaran, Indonesia
Institute
Department
Personal name
Funding Source
Organization
Self-Funding
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
Research Ethics Commitee of Universitas Padjadjaran
Address
Jalan Prof. Eijkman No. 38, 4th floor, West Wing, Bandung
Tel
0062222038697
etik.unpad@gmail.com
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
Universitas Padjadjaran, Dental and Oral Hospital- Bandung, West Java, Indonesia
Other administrative information
Date of disclosure of the study information
| 2021 | Year | 06 | Month | 01 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
32
Results
The results show that in test group, the width of wound after extraction had shrunk significantly greater than control group, both in buccolingual and mesiodistal directions.
The quality of healing process as assessed by standardized index of Landry, Turnbull and Howley (1988) showed good, very good and excellent healing in test group as follows, 5 subjects, 8 subjects and 3 subjects,respectively,
whereas in control group: 5 subjects, 10 subjects, and 1 subjects, respectively.
Results date posted
| 2021 | Year | 02 | Month | 17 | Day |
Results Delayed
| Delay expected |
Results Delay Reason
Pandemic situation
Date of the first journal publication of results
Baseline Characteristics
A total of 32 subjects (16 in test group, 16 in control group) completed the study. The phases of parallel randomized-controlled trial are shown in the Consolidated Standards of Reporting Trials (CONSORT) flow diagram. The mean age of the 32 subjects was 26.09 years without significant differences between groups and ranged in all 2 groups between 19 and 46 years. The study population consisted of 11 males and 21 females which was balanced distributed over the 2 study groups
Participant flow
A total of 32 subjects (16 in test group, 16 in control group) completed the study. The phases of parallel randomized-controlled trial are shown in the Consolidated Standards of Reporting Trials (CONSORT) flow diagram. The mean age of the 32 subjects was 26.09 years without significant differences between groups and ranged in all 2 groups between 19 and 46 years. The study population consisted of 11 males and 21 females which was balanced distributed over the 2 study groups.
Adverse events
None
Outcome measures
it is confirmed that chlorhexidine gel has the beneficial effect in enhancing wound healing after non-surgery tooth extraction and may be suggested as adjuvant treatment and home care. It merits further studies to evaluate the effect of chlorhexidine with the evaluation of clinical and radiographic examination after tooth extraction.
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2018 | Year | 12 | Month | 01 | Day |
Date of IRB
| 2018 | Year | 12 | Month | 27 | Day |
Anticipated trial start date
| 2019 | Year | 08 | Month | 01 | Day |
Last follow-up date
| 2020 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2020 | Year | 04 | Month | 01 | Day |
Date trial data considered complete
| 2020 | Year | 04 | Month | 05 | Day |
Date analysis concluded
| 2020 | Year | 04 | Month | 08 | Day |
Other
Other related information
Management information
Registered date
| 2021 | Year | 02 | Month | 17 | Day |
Last modified on
| 2022 | Year | 11 | Month | 24 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000049498
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