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

NCT ID: NCT04835532

Last Updated: 2021-09-29

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 69 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-08-10
• Study Completion Date: 2024-03-01

Brief 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.

Detailed 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.

Conditions

Bone Loss, Alveolar

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Control group

Vertical alveolar bone augmentation was performed by GBR technique before implantation.

BIO-OSS+ BIO-GIDE barrier membrane

Group Type: EXPERIMENTAL

guided bone gereration

Intervention Type: PROCEDURE

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.

Treatment group 1

Vertical alveolar bone augmentation was performed by GBR technique and tenting screws before implantation.

BIO-OSS+ BIO-GIDE barrier membrane+ tenting screws

Group Type: EXPERIMENTAL

guided bone gereration

Intervention Type: PROCEDURE

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.

Treatment group 2

Vertical alveolar bone augmentation was performed by GBR technique in combination with tenting screws and A-PRF, I-PRF before implantation.

BIO-OSS+ BIO-GIDE barrier membrane+ tenting screws+A-PRF, I-PRF

Group Type: EXPERIMENTAL

guided bone gereration

Intervention Type: PROCEDURE

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.

Interventions

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.

Intervention Type: PROCEDURE

Other Intervention Names

tenting screws, A-PRF, I-PRF

Eligibility Criteria

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 Ⅰ 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Second Affiliated Hospital, School of Medicine, Zhejiang University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

2nd Affiliated Hospital, School of Medicine, Zhejiang University, China

Hangzhou, Zhejiang, China

Site Status: RECRUITING

Countries

China

Central Contacts

陈 莉丽, Master

Role: CONTACT

chenlili_1030@163.com

+86 13606507966

Facility Contacts

陈 莉丽, Master

Role: primary

chenlili_1030@163.com

+86 13606507966

Other Identifiers

2021-0050

Identifier Type: -

Identifier Source: org_study_id