The Efficacy of Autogenous Dentin Graft in Mandibular Wisdom Tooth Extraction

Sponsor
University of Medicine and Pharmacy at Ho Chi Minh City (Other)
Overall Status
Active, not recruiting
CT.gov ID
NCT06073639
Collaborator
(none)
13
1
2
26.9
0.5

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Procedure: Autogenous dentin graft
N/A

Study Design

Study Type:
Interventional
Actual Enrollment :
13 participants
Allocation:
Randomized
Intervention Model:
Crossover Assignment
Masking:
Triple (Participant, Care Provider, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
The Clinical Effect of Autogenous Dentin Graft in Mandibular Third Molar Surgery
Actual Study Start Date :
Dec 1, 2021
Actual Primary Completion Date :
Feb 28, 2022
Anticipated Study Completion Date :
Feb 28, 2024

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

  1. Rate of self-reported pain [3 days, 7 days]

    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.

  2. Self-reported swelling [3 days, 7 days]

    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. Trismus [3 days, 7 days]

    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.

  4. Soft tissue healing score [3 days, 7 days, 30 days]

    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).

  5. Aveolar height [7 days, 2 months, 6 months, 2 years]

    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.

  6. Swelling measured by facial dimension [3 days, 7 days]

    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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Son Hoang Le Ho Chi Minh City District 5 Vietnam 72714

Sponsors and Collaborators

  • 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 Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Son Hoang Le, Lecturer, University of Medicine and Pharmacy at Ho Chi Minh City
ClinicalTrials.gov Identifier:
NCT06073639
Other Study ID Numbers:
  • VN01002/IORG00086/FWA0002448
First Posted:
Oct 10, 2023
Last Update Posted:
Oct 10, 2023
Last Verified:
Oct 1, 2023
Individual Participant Data (IPD) Sharing Statement:
Yes
Plan to Share IPD:
Yes
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Oct 10, 2023