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Comparison of autogenous tooth substitute graft and xenogeneic bone graft materials used for osseous defects after surgical removal of impacted lower third molars: Split-mouth randomized clinical trial

Comparison of autogenous tooth substitute graft and xenogeneic bone graft materials used for osseous defects after surgical removal of impacted lower third molars: Split-mouth randomized clinical trial

Status
Active, not recruiting
Phases
Phase 1Phase 2
Study type
Interventional
Source
TCTR
Registry ID
TCTR20221216003
Enrollment
15
Registered
2022-12-16
Start date
2022-12-26
Completion date
Unknown
Last updated
2026-08-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

The study conducts in healthy volunteers who have either deep mesioangulation or horizontal impacted teeth which will cause loss of alveolar bone support after surgical removal of the teeth. The bone graft materials will be put inside the tooth sockets in order to prevent the loss of alveolar bone support as aforementioned. Autogenous tooth substitute graft Xenogeneic bone graft Impacted teeth Alveolar bone loss Alveolar preservation

Interventions

1.Usual surgical removal of the 3rd molar in both experimental site and control site by using the same flap design and surgical removal technique. 2.The tooth will be completely cleaned off any soft t
Experimental Biological/Vaccine,Active Comparator Other
Autogenous tooth substitute graft ,Xenogeneic bone graft

Sponsors

Mahidol University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
20 Years to 30 Years

Inclusion criteria

Inclusion criteria: 1.Male or female aged between 20-30 years old 2.Bilateral mesioangulated or horizontal impacted mandibular 3rd molars with present 2nd molars 3.No pathological lesion involved with both the mandibular 2nd and 3rd molars and surrounding bones 4.Co-operative and able to follow the instructions

Exclusion criteria

Exclusion criteria: 1.Patients with systemic disease or medical conditions that may impair the wound healing process 2.Patients with existing active infection at either site of mandibular 3rd molars 3.Patients with generalized periodontal disease 4.Patients with smoking habit 5.Patients with orthodontic appliance

Design outcomes

Primary

MeasureTime frame
Tooth mobility Pre-operation, 2 weeks post-operation, 3 months post-operation, 6 months post-operation Miller Classification 1st Degree Tooth mobility less than 1 mm horizontally, 2nd Degree Tooth mobility more than1 mm horizontally, 3rd Degree Tooth mobility more than 1 mm with vertical mobility,Pain score Pre-operation, 2 weeks post-operation Numerical rating scale,Swelling score Pre-operation, 2 weeks post-operation The three facial lines were measured on pre-operation day and measure again on 2 weeks post-op. The percentages of increase in total facial measurements between two days were calculated. ,Nerve alteration Pre-operation, 2 weeks post-operation Any symptom of anesthesia, paresthesia or dysesthesia of the lower lip, chin, buccal gingiva, and tongue.,Presence of trismus Pre-operation, 2 weeks post-operation Measeure maximum mouth opening less than 35 mm considered as trismuss ,Presence of infection Pre-operation, 2 weeks post-operation Any symptom of purulent drainage, and any signs or symptoms of infection: pain or tenderness, localized swelling, redness, or warmth at surgical site,Soft tissue healing Pre-operation, 2 weeks post-operation Early soft tissue healing score,Mean grey value Pre-operation, 2 weeks post-operation, 3 months post-operation, 6 months post-operation The radiographic data will be digitized and saved in tag image file format. The ImageJ 2.1.0 software (GNU General Public License) will calculate the mean grey value of Region of interest (ROI),Fractal dimension Pre-operation, 2 weeks post-operation, 3 months post-operation, 6 months post-operation The radiographic data will be digitized and saved in tag image file format. The ImageJ 2.1.0 software (GNU General Public License) will calculate the fractal dimension of Region of interest (ROI),Grafted bone margin 6 months post-operation Radiolucent line between grafted material and bone scoring Score 0 Non-union, Score 1 Partial union, Score 2 Total union,Vertical bone dimension Pre-

Secondary

MeasureTime frame
Efficiency of autogenous tooth substitute graft in reducing osseous defect after surgical removal of mandibular third molar 2 weeks post-operation, 3 months post-operation, 6 months post-operation Clinical and radiographic data in primary outcomes

Countries

Thailand

Contacts

Public ContactDr. Phaichaya Laiamnuay

Faculty of Dentistry Mahidol University

phaichayal@gmail.com0849410110

Outcome results

None listed

Source: TCTR (via WHO ICTRP) · Data processed: Aug 9, 2026