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Active, not recruitingNCT06073639Updated Oct 10, 2023

The Efficacy of Autogenous Dentin Graft in Mandibular Wisdom Tooth Extraction

An interventional study of Autogenous dentin graft in Periodontal Pocket, Swelling Lips & Face and Trismus, sponsored by University of Medicine and Pharmacy at Ho Chi Minh City. Active, not recruiting at 1 site in Vietnam. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-10-10.

Sponsored by University of Medicine and Pharmacy at Ho Chi Minh City · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
13
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Periodontal Pocket
  • Swelling Lips & Face
  • Trismus
  • Pain, Acute
03

Who can participate

Ages eligible
18 Years and older
Sexes eligible
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

Exclusion Criteria:

  • Systematic health has contraindication for surgery
  • Pregnant or breastfeeding women
  • Allergy with Lidocaine
  • Abnormal signs surrounding mandibular third molars
04

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Crossover assignment
Masking
Triple (Participant, Care provider, Outcomes assessor)
Enrollment
13 participants (actual)

Study arms

  • Experimental
    Dentin graft

    Procedure: Autogenous dentin graft

  • No intervention
    Conventional

Interventions

  • ProcedureAutogenous dentin graft

    Dentin graft is made from the participant extracted tooth by using Kometa Smart Dentin Grinder

05

What researchers measure

Primary outcomes

  1. 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.

    Time frame: 3 days, 7 days

  2. 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.

    Time frame: 3 days, 7 days

  3. 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.

    Time frame: 3 days, 7 days

  4. 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).

    Time frame: 3 days, 7 days, 30 days

  5. 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.

    Time frame: 7 days, 2 months, 6 months, 2 years

  6. 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.

    Time frame: 3 days, 7 days

06

Study locations

1 site
  • Son Hoang Le
    Ho Chi Minh City, District 5 72714, Vietnam
07

References and documents

Individual participant data

Plan to share: Yes

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT06073639
Lead sponsor
University of Medicine and Pharmacy at Ho Chi Minh City
Responsible party
Son Hoang Le (Lecturer, University of Medicine and Pharmacy at Ho Chi Minh City) — Principal investigator
First posted
Oct 10, 2023
Start date
Dec 1, 2021
Primary completion
Feb 28, 2022
Completion
Feb 28, 2024 (estimated)
Last update
Oct 10, 2023

Study contacts

Son H Le
principal investigator · University of Medicine and Pharmacy at Ho Chi Minh City

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is active, not recruiting, as verified in Oct 2023. You cannot join it, but the record below documents what was studied.

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