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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

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04835532
Enrollment
69
Registered
2021-04-08
Start date
2021-08-10
Completion date
2024-03-01
Last updated
2021-09-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Bone Loss, Alveolar

Keywords

tenting screws, advanced platelet rich fibrin, injectable platelet rich fibrin, guided bone regeneration

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.

Interventions

PROCEDUREguided 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.

Sponsors

Second Affiliated Hospital, School of Medicine, Zhejiang University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)

Eligibility

Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
Yes

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.

Design outcomes

Primary

MeasureTime frameDescription
Buccal bone augmentation, BBA(bone height changes between T0 and T2)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

MeasureTime frameDescription
Lingual bone augmentation, LBA(bone height changes between T0 and T2)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

MeasureTime frameDescription
Bone density, BDT2(6 months after GBR)in the area of bone regeneration, ranging 2mm × 2mm

Countries

China

Contacts

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

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026