UMIN-CTR Clinical Trial

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
Email	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
Email	amaliya@fkg.unpad.ac.id

Sponsor
Institute	Dental Faculty - Department of Periodontology - Universitas Padjadjaran, Indonesia
Institute
Department

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
Email	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
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000049498