Tenting Screws in Combination With Platelet Concentrate for Vertical Alveolar Ridge Augmentation

Bone Loss, Alveolar Clinical Trial

Official title:

Tenting Screws in Combination With Platelet Concentrate for Vertical Alveolar Ridge Augmentation: Prospective, Blinded, Randomized Controlled Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04835532
• Other study ID #: 2021-0050
• Status: Recruiting
• Phase: N/A
• Start date: August 10, 2021
• Est. completion date: March 1, 2024

Study information

• Verified date: February 2021
• Source: Second Affiliated Hospital, School of Medicine, Zhejiang University
• Contact: ? ??, Master
• Phone: +86 13606507966
• Email: chenlili_1030[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Alveolar bone resorption often occurs after tooth extraction. At present, guided bone regeneration technique is widely used in clinic since it leads to less trauma and less complications. Tenting screw technology, basic on the classical GBR, implants screws into the surgical area to prevent the barrier membrane from collapsing. Moreover, advanced platelet rich fibrin and injectable platelet-rich fibrin are used to provide the osteogenic function. The investigators intend to increase vertical alveolar bone augmentation by combining tenting screws and A-PRF, I-PRF.

Description:

Alveolar bone resorption often occurs after tooth extraction. At present, guided bone regeneration technique is widely used in clinic since it leads to less trauma and less complications. Tenting screw technology, basic on the classical GBR, implants screws into the surgical area to prevent the barrier membrane from collapsing. Moreover, advanced platelet rich fibrin and injectable platelet-rich fibrin are used to provide the osteogenic function. The investigators intend to increase vertical alveolar bone augmentation by combining tenting screws and A-PRF, I-PRF.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 69
• Est. completion date: March 1, 2024
• Est. primary completion date: October 1, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

1. 18-80 years old;

2. single tooth in the maxillary posterior area cannot be retained (third degree loosening / alveolar bone resorption to the periapical area), implantation is needed after extraction, and CBCT shows vertical bone defect = 3mm;

3. 4 weeks after extraction or missing teeth within 3-5 weeks;

4. adjacent teeth exist and loosening is less than ? degree;

5. periodontal disease in inactive stage, whole mouth bleeding index (FMBS) is less than 20%;

6. thick gingival biological type.

7. CBCT shows that the bone of the edentulous site meets the requirements of tent screw implantation (bone height = 3mm and bone mineral density is sufficient);

8. the patients and their families have informed consent and signed the informed consent form.

Exclusion Criteria:

1. pregnant and lactating women;

2. smoking (> 10 cigarettes per day) and alcoholism;

3. taking anticoagulants within 3 months before operation;

4. suffering from autoimmune diseases, diabetes, liver disease, blood system diseases and infectious diseases;

5. patients taking any drugs that affect platelet function or whose platelet count is less than 200000/mm3 3 months before blood collection;

6. patients who have been treated with bisphosphate / steroids for a long time;

7. have received alveolar ridge bone augmentation surgery;

8. previous history of radiotherapy in the head and neck;

9. acute inflammation in edentulous sites;

10. inability to maintain good oral hygiene or follow-up visits as required.

Related Conditions & MeSH terms

• Alveolar Bone Loss
• Bone Loss, Alveolar

Intervention

Procedure:
• guided bone gereration
guided bone generation: GBR is a procedure that uses barrier membranes with or without particulate bone grafts or/and bone substitutes. tenting screws: Screws are implanted in the surgical area to prevent the barrier membrane from collapsing. A-PRF/I-PRF: Obtained by autologous blood centrifugation.

Locations

Country	Name	City	State
China	2nd Affiliated Hospital, School of Medicine, Zhejiang University, China	Hangzhou	Zhejiang

Sponsors (1)

Lead Sponsor	Collaborator
Second Affiliated Hospital, School of Medicine, Zhejiang University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Bone density, BD	in the area of bone regeneration, ranging 2mm × 2mm	T2(6 months after GBR)
Primary	Buccal bone augmentation, BBA(bone height changes between T0 and T2)	The sagittal plane of CBCT image is selected as the measuring plane, and the horizontal tangent of the inferior margin of maxillary sinus / paranasal sinus is selected as the baseline. The investigaters will measure the bone height changes by CBCT(three-dimensional CT) and Related measurement software. The unit of measurement is millimeter.	T0(before surgery), T2(6 months after GBR)
Secondary	Lingual bone augmentation, LBA(bone height changes between T0 and T2)	The sagittal plane of CBCT image is selected as the measuring plane, and the horizontal tangent of the inferior margin of maxillary sinus / paranasal sinus is selected as the baseline.; The sagittal plane of CBCT image is selected as the measuring plane, and the horizontal tangent of the inferior margin of maxillary sinus / paranasal sinus is selected as the baseline.The investigaters will measure the bone height changes by CBCT(three-dimensional CT) and Related measurement software. The unit of measurement is millimeter.	T0(before surgery), T2(6 months after GBR)