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The Efficacy of Autogenous Dentin Graft in Mandibular Wisdom Tooth Extraction

Primary Purpose

Periodontal Pocket, Swelling Lips & Face, Trismus

Status
Active
Phase
Not Applicable
Locations
Vietnam
Study Type
Interventional
Intervention
Autogenous dentin graft
Sponsored by
University of Medicine and Pharmacy at Ho Chi Minh City
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Periodontal Pocket

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria: Over 18 years old Symmetry mandibular third molars Symmetry maxillary third molars with no caries or periodontal disease Mandibular second molars are available Exclusion Criteria: Systematic health has contraindication for surgery Pregnant or breastfeeding women Allergy with Lidocaine Abnormal signs surrounding mandibular third molars

Sites / Locations

  • Son Hoang Le

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Dentin graft

Conventional

Arm Description

Outcomes

Primary Outcome Measures

Rate of self-reported pain
Pain is measured by self-reported Likert scale from 0 to 5. Higher score indicated more painful situation. Result is reported by the mean score.
Self-reported swelling
Patients reported their perception about swelling levels. There are 6 levels of this scale, score from 0 to 5. Higher score means more swelling.
Trismus
Trismus is measured by difference of maximal mouth opening between post-and pre-operative wisdom tooth surgery. Maximal mouth opening is mueasured by distance of mesial incisal edge of maxillary and mandibular central incisor.
Soft tissue healing score
The soft tissue healing score is evaluated according to Hamzami (2018). It includes 8 sub-items. Each item is recorded as 0 or 1 (score). Then, total score of the first 30 days (3 evaluation time) is used to classify wound healing level (good, acceptable, and bad).
Aveolar height
Aveolar height is measured as the distance from cementoenamel joint on distal surface of second molar to the aveolar ridge. The landmark points are defined on periapical film. The aveolar height is measured at 7 days, 3 months, 6 months and 2 years after the surgery.
Swelling measured by facial dimension
Difference of distances of facial landmark points between post-and pre-operative wisdom tooth surgery. Two distances (AB and CD) from 4 landmark points are used for measurement: A - lateral commissure of the eye, B - gonion, C - tragus, and D - lateral commissure of the lips.

Secondary Outcome Measures

Full Information

First Posted
September 25, 2023
Last Updated
October 5, 2023
Sponsor
University of Medicine and Pharmacy at Ho Chi Minh City
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1. Study Identification

Unique Protocol Identification Number
NCT06073639
Brief Title
The Efficacy of Autogenous Dentin Graft in Mandibular Wisdom Tooth Extraction
Official Title
The Clinical Effect of Autogenous Dentin Graft in Mandibular Third Molar Surgery
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
December 1, 2021 (Actual)
Primary Completion Date
February 28, 2022 (Actual)
Study Completion Date
February 28, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Medicine and Pharmacy at Ho Chi Minh City

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The study aimed to investigate clinical effect of autogenous dentin graft on patients following mandibular wisdom tooth extraction. The primary outcomes are pain, swelling, trismus and soft tissue healing index within one week after surgery. The investigators also measured periodontal healing of distal aspect of the adjacent second molar up to 2 year after the surgery.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Periodontal Pocket, Swelling Lips & Face, Trismus, Pain, Acute

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
ParticipantCare ProviderOutcomes Assessor
Allocation
Randomized
Enrollment
13 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Dentin graft
Arm Type
Experimental
Arm Title
Conventional
Arm Type
No Intervention
Intervention Type
Procedure
Intervention Name(s)
Autogenous dentin graft
Intervention Description
Dentin graft is made from the participant extracted tooth by using Kometa Smart Dentin Grinder
Primary Outcome Measure Information:
Title
Rate of self-reported pain
Description
Pain is measured by self-reported Likert scale from 0 to 5. Higher score indicated more painful situation. Result is reported by the mean score.
Time Frame
3 days, 7 days
Title
Self-reported swelling
Description
Patients reported their perception about swelling levels. There are 6 levels of this scale, score from 0 to 5. Higher score means more swelling.
Time Frame
3 days, 7 days
Title
Trismus
Description
Trismus is measured by difference of maximal mouth opening between post-and pre-operative wisdom tooth surgery. Maximal mouth opening is mueasured by distance of mesial incisal edge of maxillary and mandibular central incisor.
Time Frame
3 days, 7 days
Title
Soft tissue healing score
Description
The soft tissue healing score is evaluated according to Hamzami (2018). It includes 8 sub-items. Each item is recorded as 0 or 1 (score). Then, total score of the first 30 days (3 evaluation time) is used to classify wound healing level (good, acceptable, and bad).
Time Frame
3 days, 7 days, 30 days
Title
Aveolar height
Description
Aveolar height is measured as the distance from cementoenamel joint on distal surface of second molar to the aveolar ridge. The landmark points are defined on periapical film. The aveolar height is measured at 7 days, 3 months, 6 months and 2 years after the surgery.
Time Frame
7 days, 2 months, 6 months, 2 years
Title
Swelling measured by facial dimension
Description
Difference of distances of facial landmark points between post-and pre-operative wisdom tooth surgery. Two distances (AB and CD) from 4 landmark points are used for measurement: A - lateral commissure of the eye, B - gonion, C - tragus, and D - lateral commissure of the lips.
Time Frame
3 days, 7 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Over 18 years old Symmetry mandibular third molars Symmetry maxillary third molars with no caries or periodontal disease Mandibular second molars are available Exclusion Criteria: Systematic health has contraindication for surgery Pregnant or breastfeeding women Allergy with Lidocaine Abnormal signs surrounding mandibular third molars
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Son H Le
Organizational Affiliation
University of Medicine and Pharmacy at Ho Chi Minh City
Official's Role
Principal Investigator
Facility Information:
Facility Name
Son Hoang Le
City
Ho Chi Minh City
State/Province
District 5
ZIP/Postal Code
72714
Country
Vietnam

12. IPD Sharing Statement

Plan to Share IPD
Yes

Learn more about this trial

The Efficacy of Autogenous Dentin Graft in Mandibular Wisdom Tooth Extraction

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