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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Bone Loss, Alveolar
• Intervention / Treatment: Procedure: guided bone gereration

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.

• Study Type: Interventional
• Enrollment (Anticipated): 69
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: 陈 莉丽, Master; Phone Number: +86 13606507966; Email: chenlili_1030@163.com

Study Locations

• China
  • Zhejiang
    • Hangzhou, Zhejiang, China, 310000
      • Recruiting
      • 2nd Affiliated Hospital, School of Medicine, Zhejiang University, China
      • Contact: 陈 莉丽, Master; Phone Number: +86 13606507966; Email: chenlili_1030@163.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Control group; Vertical alveolar bone augmentation was performed by GBR technique before implantation. BIO-OSS+ BIO-GIDE barrier membrane	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.; Other Names: tenting screws, A-PRF, I-PRF
Experimental: 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	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.; Other Names: tenting screws, A-PRF, I-PRF
Experimental: 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	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.; Other Names: tenting screws, A-PRF, I-PRF

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Bone density, BD	in the area of bone regeneration, ranging 2mm × 2mm	T2(6 months after GBR)

Collaborators and Investigators

• Sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University

Study record dates

Study Major Dates

• Study Start (Actual): August 10, 2021
• Primary Completion (Anticipated): October 1, 2022
• Study Completion (Anticipated): March 1, 2024

Study Registration Dates

• First Submitted: March 16, 2021
• First Submitted That Met QC Criteria: April 4, 2021
• First Posted (Actual): April 8, 2021

Study Record Updates

• Last Update Posted (Actual): September 29, 2021
• Last Update Submitted That Met QC Criteria: September 27, 2021
• Last Verified: February 1, 2021

More Information

Terms related to this study

• Keywords: guided bone regeneration; tenting screws; advanced platelet rich fibrin; injectable platelet rich fibrin
• Additional Relevant MeSH Terms: Musculoskeletal Diseases; Stomatognathic Diseases; Periodontal Diseases; Mouth Diseases; Bone Diseases; Periodontal Atrophy; Bone Resorption; Alveolar Bone Loss
• Other Study ID Numbers: 2021-0050

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No