Comparative Study of APRF/CGF Technology in GTR

Chronic Periodontitis Clinical Trial

Official title:

Comparative Study of Advance Platelet Rich Fibrin/Concentrated Growth Factor Technology in Regenerative Periodontal Surgery: a Randomized Controlled Clinical Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04953260
• Other study ID #: 2020-1021
• Status: Recruiting
• Phase: N/A
• Start date: August 25, 2020
• Est. completion date: March 2022

Study information

• Verified date: January 2021
• Source: Second Affiliated Hospital, School of Medicine, Zhejiang University
• Contact: Lihong Lei, associate senior doctor
• Phone: 13989463654
• Email: zjullh[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Guided tissue regeneration(GTR) uses membranous materials to shield gingival epithelial cells and connective tissue cells which grow more rapidly, creating an effective closed space and time for periodontal ligament cells with regenerative potential, so that new cementum is formed on the root surface and periodontal ligament fibers are embedded, resulting in regenerative healing. In order to improve the effect of periodontal regeneration therapy, as early as 1990s, scholars began to mix platelet concentrate and bone graft in periodontal regenerative surgery to improve the ability of local bone induction and tissue healing. Studies have shown that platelet concentrate, which is rich in a variety of growth factors in autologous blood, can promote soft tissue and bone tissue healing by acting on tissue healing cells (osteoblasts, epithelial cells, connective tissue cells, etc.). It is closely related to periodontal regeneration; the regenerative component of platelet concentrate, growth factor, and the structure of fibrin network containing growth factor are the key to promote tissue repair and regeneration.Modified platelet-rich fibrin (advanced platelet rich fibrin,APRF) and concentrated growth factor (CGF) are the latest generation of platelet concentrates. A number of studies have shown that APRF and CGF contain more cytokines, have a denser fibrin network, and show stronger ability to promote the migration and proliferation of gingival fibroblasts, suggesting that both of them may have better ability to promote bone tissue healing. At present, the latest generation of platelet concentrate has been widely used in implant surgery, but their clinical effects in periodontal regeneration surgery are still lack of conclusive evidence. there is no report on comparing the clinical effects of the two through randomized clinical controlled trials.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 78
• Est. completion date: March 2022
• Est. primary completion date: March 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

1. The age of the patient is 18-80 years old.

2. selection of affected teeth: there is still at least one site of periodontal probing depth ((PD) = 5mm) at 6-8 weeks after initial periodontal treatment,and the degree of mobility is less than grade II or II-III degree but without mobility after fixation.Imaging evaluation shows that the tooth has a Intrabony defect which is larger than 3mm, and there is no history of periodontal surgery at this site, and the affected tooth has no obvious symptoms of discomfort.

3. The patient has good compliance, good plaque control after basic treatment (bleeding index and plaque index < 20%). He/She can understand the purpose of the test and is willing to cooperate with surgical treatment and follow-up. He/She voluntarily participates in the trial and signs informed consent.

Exclusion Criteria:

1. In the past 6 months, patients who chewed smokeless tobacco, smoked a pipe or cigar once a week, or smoked more than 20 cigarettes per week (1 pack per week);

2. Patients took any drug affecting platelet function or had a platelet count less than 200000/mm3 3 months before blood collection.

3. Patients have taken antiepileptic drugs, antihistamines, antidepressants, sedatives, sedatives, anti-inflammatory drugs or daily analgesics within 1 month before operation;

4. Patients with a history of diabetes or patients with abnormal blood glucose test (fasting blood glucose = 7mmol/L);

5. Liver and renal dysfunction (AST, ALT = 1.5 times ULN, creatinine = 1.5 times ULN);

6. Patients with severe endocrine and metabolic diseases.

7. Those with a history of grade 3 hypertension;

8. Those with a history of osteoporosis;

9. Those with a history of autoimmune diseases;

10. Those with a history of malignant tumor or other serious diseases who are not suitable for surgery or cause observation of tooth loss;

11. Pregnant or lactating women;

12. Patients with local anesthetic allergy.

13. Clinical or radiological findings showed acute infection, apical lesions, root fractures, severe root deformities, cementum beads, indelible enamel protuberances, untreated caries at the enamel or root boundary, and restoration reaching subgingival and/or below CEJ or marginal incongruity

14. All kinds of subjects who can cause artifacts in oral imaging examination, such as:

the study teeth and their adjacent teeth are metal dentures and porcelain teeth;

15. The affected teeth have root furcation lesions

Related Conditions & MeSH terms

• Chronic Periodontitis
• Intrabony Periodontal Defect
• Periodontitis

Intervention

Other:
• APRF
20ml venous blood was collected from the elbow before operation and centrifuged with a special centrifuge. One piece of APRF gel was chopped and mixed with Bio-oss, and the other piece was pressed into a thin film; the mixture of APRF and Bio-oss was filled into the bone defect, covered with a properly trimmed Bio-gide film, and then covered with APRF film
• CGF
20ml venous blood was collected from the elbow before operation and centrifuged with a special centrifuge. One piece of CGF gel was chopped and mixed with Bio-oss, and the other piece was pressed into a thin film; the mixture of CGF and Bio-oss was filled into the bone defect, covered with a properly trimmed Bio-gide film, and then covered with CGF film

Locations

Country	Name	City	State
China	Lei Lihong	Hangzhou

Sponsors (1)

Lead Sponsor	Collaborator
Second Affiliated Hospital, School of Medicine, Zhejiang University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	CAL (clinical attachment level)	The distance from periodontal pocket bottom to CEJ was measured by periodontal probe (mm). Record six sites of each tooth (the mesial, median and distal site of the buccal and tongue surface ).In order to ensure the operability and scientificity of follow-up, it is defined as follows.	Baseline(V0),Change from Baseline at 12 weeks (V1),Change from Baseline at 24 weeks (V2),Change from Baseline at 48 weeks (V3)
Secondary	PD(probe depth)	use a periodontal probe (UNC-15,Hu-Friedy,Chicago,IL) paralleling to the long axis of the tooth to measure the distance from the bottom of the periodontal pocket to the gingival margin (mm), record six sites of each tooth (the mesial, median and distal site of the buccal and tongue surface ).	Baseline(V0),Change from Baseline at 12 weeks (V1),Change from Baseline at 24 weeks (V2),Change from Baseline at 48 weeks (V3)
Secondary	mobility	use a tweezer to clamp the incisal areas of the anterior teeth or the pit groove on the occlusal surface of the posterior teeth and shake the teeth faciolingually, mesiodistally and vertically I degree : abnormal mobility faciolingually or less than 1mm positioning II degree : abnormal mobility faciolingually and mesiodistally or loosening range of 1-2mm.; III degree : abnormal mobility faciolingually, mesiodistally and vertically or loosening range is greater than 2mm.	Baseline(V0),Change from Baseline at 12 weeks (V1),Change from Baseline at 24 weeks (V2),Change from Baseline at 48 weeks (V3)
Secondary	BOP(bleeding of probe)	observe for 10-15 seconds after probe to see whether it bleeds.Record six sites of each tooth (the mesial, median and distal site of the buccal and tongue surface ).	Baseline(V0),Change from Baseline at 12 weeks (V1),Change from Baseline at 24 weeks (V2),Change from Baseline at 48 weeks (V3)
Secondary	RBL(adiographic bone level)	Locate the reference point at the deepest PD site of the affected tooth:cemento-enamel junction(CEJ),alveolar crest(AC),bone defect(BD).RBL is the straight line distance from CEJ to BD (mm)	Baseline(V0),Change from Baseline at 24 weeks (V2),Change from Baseline at 48 weeks (V3)
Secondary	IC	IC is the straight line distance from AC to BD (mm)	Baseline(V0),Change from Baseline at 24 weeks (V2),Change from Baseline at 48 weeks (V3)
Secondary	regenerated bone volume parameters	in mimics software, threshold was set according to the gray value of the affected tooth and its surrounding alveolar bone, image editing and region growth were used to form a mask of the three-dimensional reconstruction area. The three-dimensional calculation function was used to reconstruct the three-dimensional shape of the alveolar bone in the target area. Furthermore, the structure of alveolar bone was optimized by remeshing and smooth. The volume of alveolar bone before and after operation was calculated by Boolean operation to obtain the model of regenerated alveolar bone and its volume was measured.	Baseline(V0),Change from Baseline at 24 weeks (V2),Change from Baseline at 48 weeks (V3)
Secondary	Defect fill (%)	Defect fill (%) = (preoperative IC- and postoperative IC) / preoperative IC × 100%	Baseline(V0),Change from Baseline at 24 weeks (V2),Change from Baseline at 48 weeks (V3)
Secondary	Defect resolution (%)	Defect resolution (%) = (preoperative RBL- and postoperative RBL) / preoperative RBL × 100%	Baseline(V0),Change from Baseline at 24 weeks (V2),Change from Baseline at 48 weeks (V3)