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

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ClinicalTrials.gov Identifier: NCT04835532
Recruitment Status : Recruiting
First Posted : April 8, 2021
Last Update Posted : September 29, 2021
Sponsor:
Information provided by (Responsible Party):
Second Affiliated Hospital, School of Medicine, Zhejiang University

Study Description
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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.

Condition or disease Intervention/treatment Phase
Bone Loss, Alveolar Procedure: guided bone gereration Not Applicable

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 Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 69 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Tenting Screws in Combination With Platelet Concentrate for Vertical Alveolar Ridge Augmentation: Prospective, Blinded, Randomized Controlled Trial
Actual Study Start Date : August 10, 2021
Estimated Primary Completion Date : October 1, 2022
Estimated Study Completion Date : March 1, 2024
Arms and Interventions
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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 Name: 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 Name: 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 Name: tenting screws, A-PRF, I-PRF


Outcome Measures
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Primary Outcome Measures :
  1. Buccal bone augmentation, BBA(bone height changes between T0 and T2) [ Time Frame: T0(before surgery), T2(6 months after GBR) ]
    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 :
  1. Lingual bone augmentation, LBA(bone height changes between T0 and T2) [ Time Frame: T0(before surgery), T2(6 months after GBR) ]

    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.



Other Outcome Measures:
  1. Bone density, BD [ Time Frame: T2(6 months after GBR) ]
    in the area of bone regeneration, ranging 2mm × 2mm


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04835532


Contacts
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Contact: 陈 莉丽, Master +86 13606507966 chenlili_1030@163.com

Locations
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China, Zhejiang
2nd Affiliated Hospital, School of Medicine, Zhejiang University, China Recruiting
Hangzhou, Zhejiang, China, 310000
Contact: 陈 莉丽, Master    +86 13606507966    chenlili_1030@163.com   
Sponsors and Collaborators
Second Affiliated Hospital, School of Medicine, Zhejiang University
More Information
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Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
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Responsible Party: Second Affiliated Hospital, School of Medicine, Zhejiang University
ClinicalTrials.gov Identifier: NCT04835532    
Other Study ID Numbers: 2021-0050
First Posted: April 8, 2021    Key Record Dates
Last Update Posted: September 29, 2021
Last Verified: February 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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
Keywords provided by Second Affiliated Hospital, School of Medicine, Zhejiang University:
tenting screws
advanced platelet rich fibrin
injectable platelet rich fibrin
guided bone regeneration
Additional relevant MeSH terms:
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Alveolar Bone Loss
Bone Resorption
Bone Diseases
Musculoskeletal Diseases
 Periodontal Atrophy
Periodontal Diseases
Mouth Diseases
Stomatognathic Diseases