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

Primary Purpose

Bone Loss, Alveolar

Status
Recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
guided bone gereration
Sponsored by
Second Affiliated Hospital, School of Medicine, Zhejiang University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Bone Loss, Alveolar focused on measuring tenting screws, advanced platelet rich fibrin, injectable platelet rich fibrin, guided bone regeneration

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • 2nd Affiliated Hospital, School of Medicine, Zhejiang University, ChinaRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Experimental

Arm Label

Control group

Treatment group 1

Treatment group 2

Arm Description

Vertical alveolar bone augmentation was performed by GBR technique before implantation. BIO-OSS+ BIO-GIDE barrier membrane

Vertical alveolar bone augmentation was performed by GBR technique and tenting screws before implantation. BIO-OSS+ BIO-GIDE barrier membrane+ tenting screws

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.

Full Information

First Posted
March 16, 2021
Last Updated
September 27, 2021
Sponsor
Second Affiliated Hospital, School of Medicine, Zhejiang University
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1. Study Identification

Unique Protocol Identification Number
NCT04835532
Brief Title
Tenting Screws in Combination With Platelet Concentrate for Vertical Alveolar Ridge Augmentation
Official Title
Tenting Screws in Combination With Platelet Concentrate for Vertical Alveolar Ridge Augmentation: Prospective, Blinded, Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
February 2021
Overall Recruitment Status
Recruiting
Study Start Date
August 10, 2021 (Actual)
Primary Completion Date
October 1, 2022 (Anticipated)
Study Completion Date
March 1, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Second Affiliated Hospital, School of Medicine, Zhejiang University

4. Oversight

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

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bone Loss, Alveolar
Keywords
tenting screws, advanced platelet rich fibrin, injectable platelet rich fibrin, guided bone regeneration

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
69 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Control group
Arm Type
Experimental
Arm Description
Vertical alveolar bone augmentation was performed by GBR technique before implantation. BIO-OSS+ BIO-GIDE barrier membrane
Arm Title
Treatment group 1
Arm Type
Experimental
Arm Description
Vertical alveolar bone augmentation was performed by GBR technique and tenting screws before implantation. BIO-OSS+ BIO-GIDE barrier membrane+ tenting screws
Arm Title
Treatment group 2
Arm Type
Experimental
Arm Description
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
Intervention Type
Procedure
Intervention Name(s)
guided bone gereration
Other Intervention Name(s)
tenting screws, A-PRF, I-PRF
Intervention Description
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.
Primary Outcome Measure Information:
Title
Buccal bone augmentation, BBA(bone height changes between T0 and T2)
Description
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.
Time Frame
T0(before surgery), T2(6 months after GBR)
Secondary Outcome Measure Information:
Title
Lingual bone augmentation, LBA(bone height changes between T0 and T2)
Description
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.
Time Frame
T0(before surgery), T2(6 months after GBR)
Other Pre-specified Outcome Measures:
Title
Bone density, BD
Description
in the area of bone regeneration, ranging 2mm × 2mm
Time Frame
T2(6 months after GBR)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: 18-80 years old; 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; 4 weeks after extraction or missing teeth within 3-5 weeks; adjacent teeth exist and loosening is less than Ⅰ degree; periodontal disease in inactive stage, whole mouth bleeding index (FMBS) is less than 20%; thick gingival biological type. 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); the patients and their families have informed consent and signed the informed consent form. Exclusion Criteria: pregnant and lactating women; smoking (> 10 cigarettes per day) and alcoholism; taking anticoagulants within 3 months before operation; suffering from autoimmune diseases, diabetes, liver disease, blood system diseases and infectious diseases; patients taking any drugs that affect platelet function or whose platelet count is less than 200000/mm3 3 months before blood collection; patients who have been treated with bisphosphate / steroids for a long time; have received alveolar ridge bone augmentation surgery; previous history of radiotherapy in the head and neck; acute inflammation in edentulous sites; inability to maintain good oral hygiene or follow-up visits as required.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
陈 莉丽, Master
Phone
+86 13606507966
Email
chenlili_1030@163.com
Facility Information:
Facility Name
2nd Affiliated Hospital, School of Medicine, Zhejiang University, China
City
Hangzhou
State/Province
Zhejiang
ZIP/Postal Code
310000
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
陈 莉丽, Master
Phone
+86 13606507966
Email
chenlili_1030@163.com

12. IPD Sharing Statement

Plan to Share IPD
No

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

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