The Efficacy of Autogenous Dentin Graft in Mandibular Wisdom Tooth Extraction

Pain, Acute Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT06073639
• Other study ID #: VN01002/IORG00086/FWA0002448
• Status: Active, not recruiting
• Phase: N/A
• Start date: December 1, 2021
• Est. completion date: February 28, 2024

Study information

• Verified date: October 2023
• Source: University of Medicine and Pharmacy at Ho Chi Minh City
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 13
• Est. completion date: February 28, 2024
• Est. primary completion date: February 28, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

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

Intervention

Procedure:
• Autogenous dentin graft
Dentin graft is made from the participant extracted tooth by using Kometa Smart Dentin Grinder

Locations

Country	Name	City	State
Vietnam	Son Hoang Le	Ho Chi Minh City	District 5

Sponsors (1)

Lead Sponsor	Collaborator
University of Medicine and Pharmacy at Ho Chi Minh City

Country where clinical trial is conducted

Vietnam, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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