NCT06073639

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
13

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Dec 2021

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2021

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 28, 2022

Completed
1.6 years until next milestone

First Submitted

Initial submission to the registry

September 25, 2023

Completed
15 days until next milestone

First Posted

Study publicly available on registry

October 10, 2023

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 28, 2024

Completed
Last Updated

October 10, 2023

Status Verified

October 1, 2023

Enrollment Period

3 months

First QC Date

September 25, 2023

Last Update Submit

October 5, 2023

Conditions

Periodontal PocketSwelling Lips & FaceTrismusPain, Acute

Outcome Measures

Primary Outcomes (6)

  • 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

Study Arms (2)

Dentin graft

EXPERIMENTAL
Procedure: Autogenous dentin graft

Conventional

NO INTERVENTION

Interventions

Autogenous dentin graftPROCEDURE

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

Dentin graft

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Over 18 years old
  • Symmetry mandibular third molars
  • Symmetry maxillary third molars with no caries or periodontal disease
  • Mandibular second molars are available

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Son Hoang Le

Ho Chi Minh City, District 5, 72714, Vietnam

Location

MeSH Terms

Conditions

Periodontal PocketFaciesTrismusAcute Pain

Condition Hierarchy (Ancestors)

PeriodontitisPeriodontal DiseasesMouth DiseasesStomatognathic DiseasesDisease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsSpasmNeuromuscular ManifestationsNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPain

Study Officials

  • Son H Le

    University of Medicine and Pharmacy at Ho Chi Minh City

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Lecturer

Study Record Dates

First Submitted

September 25, 2023

First Posted

October 10, 2023

Study Start

December 1, 2021

Primary Completion

February 28, 2022

Study Completion

February 28, 2024

Last Updated

October 10, 2023

Record last verified: 2023-10

Data Sharing

IPD Sharing
Will share

Locations

VN(1)