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

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What is being tested

guided bone gereration

Procedure
Who is being recruted

Bone Diseases+5

+ Bone Resorption

+ Stomatognathic Diseases

From 18 to 80 Years
+18 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Treatment Study

Interventional
Study Start: August 2021
See protocol details

Summary

Principal SponsorSecond Affiliated Hospital, School of Medicine, Zhejiang University
Study Contact陈 莉丽, Master
Last updated: January 28, 2026
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Study start date: August 10, 2021

Actual date on which the first participant was enrolled.

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.

Official TitleTenting Screws in Combination With Platelet Concentrate for Vertical Alveolar Ridge Augmentation: Prospective, Blinded, Randomized Controlled Trial
NCT04835532
Principal SponsorSecond Affiliated Hospital, School of Medicine, Zhejiang University
Study Contact陈 莉丽, Master
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

69 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

From 18 to 80 Years

Range of ages for which participants are eligible to join.

Healthy volunteers allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Bone DiseasesBone ResorptionStomatognathic DiseasesMouth DiseasesMusculoskeletal DiseasesPeriodontal DiseasesAlveolar Bone LossPeriodontal Atrophy

Criteria

8 inclusion criteria required to participate
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;
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10 exclusion criteria prevent from participating
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;
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Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

3 intervention groups are designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

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

Group II

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

Group III

Experimental
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

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Recruiting

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

Hangzhou, ChinaOpen 2nd Affiliated Hospital, School of Medicine, Zhejiang University, China in Google Maps
SuspendedOne Study Center