The Efficacy of Autogenous Dentin Graft in Mandibular Wisdom Tooth Extraction

The Clinical Effect of Autogenous Dentin Graft in Mandibular Third Molar Surgery

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Pain, Acute; Trismus; Periodontal Pocket; Swelling Lips & Face
• Intervention / Treatment: Procedure: Autogenous dentin graft

• Study Type: Interventional
• Enrollment (Actual): 13
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Vietnam
  • District 5
    • Ho Chi Minh City, District 5, Vietnam, 72714
      • Son Hoang Le

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Dentin graft	Procedure: Autogenous dentin graft; Dentin graft is made from the participant extracted tooth by using Kometa Smart Dentin Grinder
No Intervention: Conventional

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	3 days, 7 days
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.	3 days, 7 days
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.	3 days, 7 days
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).	3 days, 7 days, 30 days
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.	7 days, 2 months, 6 months, 2 years
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.	3 days, 7 days

Collaborators and Investigators

• Sponsor: University of Medicine and Pharmacy at Ho Chi Minh City
• Investigators: Principal Investigator: Son H Le, University of Medicine and Pharmacy at Ho Chi Minh City

Study record dates

Study Major Dates

• Study Start (Actual): December 1, 2021
• Primary Completion (Actual): February 28, 2022
• Study Completion (Estimated): February 28, 2024

Study Registration Dates

• First Submitted: September 25, 2023
• First Submitted That Met QC Criteria: October 5, 2023
• First Posted (Estimated): October 9, 2023

Study Record Updates

• Last Update Posted (Estimated): October 9, 2023
• Last Update Submitted That Met QC Criteria: October 5, 2023
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nervous System Diseases; Pain; Neurologic Manifestations; Stomatognathic Diseases; Periodontal Diseases; Mouth Diseases; Neuromuscular Manifestations; Periodontitis; Spasm; Acute Pain; Trismus; Periodontal Pocket
• Other Study ID Numbers: VN01002/IORG00086/FWA0002448

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No