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Ramdomized controlled trial on extraction socket healing with a collagen sponge block(Atelopug®))

Status Approved

First Submitted Date

2018/08/31
Registered Date

2018/11/21
Last Updated Date

2018/11/14

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CRIS Required

WHO ICTRP (International Clinical Trial Registry Platform) Required

1. Background

Background - CRIS Registration Number, Unique Protocol ID, Public/Brief Title, Scientific Title, Acronym, MFDS Regulated Study, IND/IDE Protocol, Registered at Other Registry, Name of Registry/Registration Number
CRIS Registration Number	KCT0003363
Unique Protocol ID	ECT 13-23A-05
Public/Brief Title	Randomized controlled trial on the effectiveness of absorbable collagen sponge after extraction of impacted mandibular third molar: Split-mouth design
Scientific Title	Ramdomized controlled trial on extraction socket healing with a collagen sponge block(Atelopug®))
Acronym
MFDS Regulated Study	No
IND/IDE Protocol	No
Registered at Other Registry	No
Healthcare Benefit Approval Status	Not applicable

2. Institutional Review Board / Ethics Committee

Institutional Review Board Information
Board Approval Status	Submitted approval
Board Approval Number	ECT 13-23A-05
Approval Date	2013-07-17
Institutional Review Board Name	Ewha womans university Mokdong hospital Institutional Review Board
Institutional Review Board Address	1071, Anyangcheon-ro, Yangcheon-gu, Seoul
Institutional Review Board Telephone	02-2650-5872
Data Monitoring Committee	No

3. Contact Details

Contact Details Information - Contact Person for Principal Investigator / Scientific Queries, Contact Person for Public Queries, Contact Person for Updating Information의 Name, Title, Email, Telephone, Cellular Phone, Affiliation, Address
Contact Person for Principal Investigator / Scientific Queries
Name	Kim Sun-Jong
Title	Professor
Telephone	+82-2-2650-2720
Affiliation	Ewha Womans University Medical Center
Address	Anyangcheon-ro 1071, Yangcheon-gu, Seoul, 158-710, Korea
Contact Person for Public Queries
Name	Kim Jin-Woo
Title	Assistant Professor
Telephone	+82-2-2650-2720
Affiliation	Ewha Womans University Medical Center
Address	Anyangcheon-ro 1071, Yangcheon-gu, Seoul, 158-710, Korea
Contact Person for Updating Information
Name	Seong Tae-Whan
Title	Resident
Telephone	+82-2-2650-2720
Affiliation	Ewha Womans University Medical Center
Address	Anyangcheon-ro 1071, Yangcheon-gu, Seoul, 158-710, Korea

4. Status

Status Information - Study Site, Overall Recruitment Status, Date of First Enrollment, Status of First Enrollment, Target Number of Participant, Primary Completion Date, Recruitment Status by Participating Study Site, Name of Study Site, Recruitment Status, Date of First Enrollment, Status of First Enrollemnt
Recruitment Status by Participating Study Site 1
Study Site	Single
Overall Recruitment Status	Completed
Date of First Enrollment	2013-10-21 Actual
Target Number of Participant	34
Primary Completion Date	2015-03-25 , Actual
Study Completion Date	2015-03-25 , Actual
Name of Study	Ewha Womans University Medical Center
Recruitment Status	Completed
Date of First Enrollment	2013-10-21 ,

5. Source of Monetary / Material Support

Source of Monetary / Material Support Information - Organization Name, Organization Type, Project ID
1. Source of Monetary/Material Support
Organization Name	National Research Foundation
Organization Type	Others
Project ID	ECT 13-23A-05

6. Sponsor Organization

Sponsor Organization Information - Organization Name, Organization Type
1. Sponsor Organization
Organization Name	Ewha Womans University Medical Center
Organization Type	Medical Institute

7. Study Summary

Study Summary Information
Lay Summary	Extraction of mandibular third molar is a common minor surgery in oral and maxillofacial surgery. Acute or chronic peri-coronitis, dentigerous cysts, periodontal disease and dental caries in adjacent second molar are the reason for extraction. However, the mandibular third molar is commonly impacted because of a narrow arch and inadequate space, hence, lack of eruption. This impacted mandibular third molar extraction often leads to some complications associated with periodontal defects at the distal surface of the second molar, bleeding, swelling, pain, trismus and alveolitis. Various treatment methods have been used to prevent post-operative complications and enhance healing of periodontal defects distal to second molar. Scaling and root planning the distal aspect of second molar, utilization of different flap design for third molar extraction, variation in suturing, bone graft with or without membrane to extraction socket, bone graft with absorbable or non-absorbable membrane, use of guided tissue regeneration for new attachment, application of autologous platelet rich plasma gel to extraction socket, insertion of absorbable collagen sponge to extraction socket were reported. One of these methods, the placement of absorbable collagen sponge has been reported to have many advantages. It acts as an extra-cellular matrix, favors the immigration of osteoblasts, blood clot stabilization, soft tissue healing, wound protection and bone reconstruction. Hence, absorbable collagen sponge has been recommended and used widely in oral and maxillofacial surgeons to reduce post-operative complications and to obtain favorable prognosis after surgery. Although there were some studies on the effects of collagen sponge insertion after tooth extraction, there were few studies including following assesment : post-operative complications, periodontal defects and radiographic evaluation using the method of randomized controlled trial. Thus, the purpose of this study is to investigate the effectiveness of collagen sponge insertion after extraction of impacted mandibular third molar.

Study Summary Information

Lay Summary

Extraction of mandibular third molar is a common minor surgery in oral and maxillofacial surgery. Acute or chronic peri-coronitis, dentigerous cysts, periodontal disease and dental caries in adjacent second molar are the reason for extraction. However, the mandibular third molar is commonly impacted because of a narrow arch and inadequate space, hence, lack of eruption. This impacted mandibular third molar extraction often leads to some complications associated with periodontal defects at the distal surface of the second molar, bleeding, swelling, pain, trismus and alveolitis.
	Various treatment methods have been used to prevent post-operative complications and enhance healing of periodontal defects distal to second molar. Scaling and root planning the distal aspect of second molar, utilization of different flap design for third molar extraction, variation in suturing, bone graft with or without membrane to extraction socket, bone graft with absorbable or non-absorbable membrane, use of guided tissue regeneration for new attachment, application of autologous platelet rich plasma gel to extraction socket, insertion of absorbable collagen sponge to extraction socket were reported.
	One of these methods, the placement of absorbable collagen sponge has been reported to have many advantages. It acts as an extra-cellular matrix, favors the immigration of osteoblasts, blood clot stabilization, soft tissue healing, wound protection and bone reconstruction. Hence, absorbable collagen sponge has been recommended and used widely in oral and maxillofacial surgeons to reduce post-operative complications and to obtain favorable prognosis after surgery. 
	Although there were some studies on the effects of collagen sponge insertion after tooth extraction, there were few studies including following assesment : post-operative complications, periodontal defects and radiographic evaluation using the method of randomized controlled trial.
 	Thus, the purpose of this study is to investigate the effectiveness of collagen sponge insertion after extraction of impacted mandibular third molar.

8. Study Design

Study Design Information - Study Type, Study Purpose, Phase, Intervention Model, Blinding/Masking, Blinded Subject, Allocation, Intervention Type, Intervention Description, Number of Arms, Arm Label, Target Number of Participant, Arm Type, Arm Description
Study Type	Interventional Study
Study Purpose	Treatment
Phase	Not applicable
Intervention Model	Others (Comparing with collagen sponge insertion and no-collagen sponge insertion group after extraction of impacted mandibular third molar)
Blinding/Masking	Open
Allocation	RCT
Intervention Type	Medical Device
Intervention Description	Investigate the effectiveness of collagen sponge insertion by comparing with control(no-collagen sponge insertion) group after extraction of impacted mandibular third molar including following assesment : post-operative complications, periodontal defects and radiographic evaluation using the method of randomized controlled trial. Follow up period is pre-operation, post-operatively 1 week, 2weeks, 14 weeks.
Number of Arms	1
Arm 1	Arm Label Collagen sponge insertion after extraction
	Target Number of Participant 34
	Arm Type Experimental
	Arm Description Collagen sponge insertion after extraction of impacted mandibular third molar No collagen sponge insertion after extractino of impacted mandibular third molar ( same patient and opposite site of control group)

9. Subject Eligibility

Subject Eligibility Information
Condition(s)/Problem(s)	* (K00-K93)Diseases of the digestive system (K01.173)Impacted teeth of mandibular third molar
Rare Disease	No
Inclusion Criteria	Gender Both
	Age 19Year~25Year
	Description Healthy patients who visited Department of Oral and Maxillofacial surgery, Ewha Womans University Hospital Mok-dong Medical Center for preventive impacted mandibular third molar extraction between July 2013 and June 2015 satisfying inclusion criteria were selected for study. Patients with bilateral mandibular impacted third molars based on same Pell-Gregory classification (impacted depth and ramus relationship) and Winter classification (impacted angulation) were selected.
Exclusion Criteria	1)Patients with infectious disease (HIV, HBV) and patients 2)Patients who show sensitivity to porcine derived material 3)Patients who had peri-coronitis or peri-apical inflammation
Healthy Volunteers	Yes

10. Outcome Measure(s)

Outcome Measure(s) Information - Type of Primary Outcome, Primary Outcome, Outcome, Timepoint, Secondary Outcome, Outcome, Timepoint
Primary Outcome(s) 1
Type of Primary Outcome	Efficacy
Outcome	VAS score
Timepoint	Post-operatively 1 week, 2 weeks, 14 weeks
Primary Outcome(s) 2
Outcome	Facial swelling
Timepoint	Post-operatively 1 week, 2 weeks, 14 weeks
Primary Outcome(s) 3
Outcome	Maximum mouth opening
Timepoint	Pre-operation, Post-operatively 1 week, 2 weeks, 14 weeks
Primary Outcome(s) 4
Outcome	Probing depth, Gingiva recession, Gingiva index, Bleeding on probing
Timepoint	Pre-operation, Post-operatively 1 week, 2 weeks, 14 weeks
Primary Outcome(s) 5
Outcome	Lamina dura, Overall density, Trabecular pattern
Timepoint	Pre-operation, Post-operatively 1 week, 2 weeks, 14 weeks
Secondary Outcome(s) 1
Outcome	Time group effect
Timepoint	Post-operatively 1 week, 2 weeks, 14 weeks

11. Study Results and Publication

Study Results and Publication Information - Result Registered, Final Enrollment Number, Number of Publication, Publications, Results Upload, Date of Posting Results, Protocol URL or File Upload, Brief Summary
Result Registered	Yes Results Upload
Final Enrollment Number	31
Number of Publication	0
Results Upload	CRIS 결과.pdf
Date of Posting Results	2018/11/21
Protocol URL or File Upload	Protocol CRIS.pdf
Brief Summary	Collagen sponge can help to reduce patient’s post-operative complications at an early stage and enhance initial healing of soft tissue and periodontal defects.

12. Sharing of Study Data(Deidentified Individual-Patient Data, IPD)

Sharing of Study Data Information - Sharing Statement, Time of Sharing, Way of Sharing
Sharing Statement	No

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