Three-dimensional volumetric assessment and stability of simultaneously placed implant following sinus floor augmentation with deproteinized human demineralized tooth matrix or deproteinized bovine bone mineral: a randomized controlled clinical trial

Phase 1

Completed

• Conditions: Demineralized deproteinized tooth matrix Graft sinus floor reduction; Tooth graft; Implant stability; Sinus floor augmentation; Volume reduction; Healthy patients need simultaneous implant placement with sinus augmentation utilizing the lateral window technique and had residual alveolar bone heights between 3 to 6 mm.

• Registration Number: TCTR20200929002
• Lead Sponsor: Ministry of Higher Education, Science, Research and Innovation, Prince of Songkla University

Brief Summary

dpDTM demonstrated comparable stability in graft volume and height during the healing process compared to DBBM and could serve as a viable alternative to DBBM for sinus floor augmentation with simultaneous implant placement.

Detailed Description

Not available

Study Timeline

• Study Start: 2020-09-29
• Study Completion: 2023-01-19
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 24

Inclusion Criteria

1.Healthy patients, the ages of 20-60 years
2.Required simultaneous implant placement with sinus augmentation (lateral window technique)
3.residual alveolar bone heights between 3 to 6 mm.

Exclusion Criteria

1.Pregnancy or lactating
2.History of malignancy/radiotherapy/chemotherapy for malignancy in the past 5yrs.
3.Medical history is a contraindication for oral surgery treatment
4.Autoimmune disease/ Metabolic bone disease.
5.A patient just was diagnosed be malignancy and then need to treat urgency
6.Present active infection at maxillary sinus or chronic sinusitis after surgery
7.Long-term used of NSAIDs, steroid or antibiotic drugs
8.Bisphosphonate therapy
9.Untreated severe periodontal disease
10.The patient cannot follow appointment
11.heavy smokers (more than 10 cigarettes per day).

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
volume stability immediate, 6 months postoperative CBCT scan,graft height alteration immediate, 6 months postoperative CBCT scan

Secondary Outcome Measures

Name	Time	Method
implant stability immediated and 6 months postoperation Resonance Frequency Analysis (RFA)