Comparative Study of APRF/CGF Technology in GTR

NCT04953260 | Unknown

• 1 other identifier: 2020-1021
• Study Type: interventional
• Target: 78
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Chronic Periodontitis; Intrabony Periodontal Defect

Keywords

guided tissue regeneration; APRF; CGF; Intrabony defect; Chronic periodontitis

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (8)

• PD（probe depth）

  Baseline(V0)，Change from Baseline at 12 weeks (V1)，Change from Baseline at 24 weeks (V2)，Change from Baseline at 48 weeks (V3)

• mobility

  Baseline(V0)，Change from Baseline at 12 weeks (V1)，Change from Baseline at 24 weeks (V2)，Change from Baseline at 48 weeks (V3)

• BOP(bleeding of probe)

  Baseline(V0)，Change from Baseline at 12 weeks (V1)，Change from Baseline at 24 weeks (V2)，Change from Baseline at 48 weeks (V3)

• RBL（adiographic bone level）

  Baseline(V0)，Change from Baseline at 24 weeks (V2)，Change from Baseline at 48 weeks (V3)

• IC

  Baseline(V0)，Change from Baseline at 24 weeks (V2)，Change from Baseline at 48 weeks (V3)

Study Arms (3)

GTR group

NO INTERVENTION

only conventional GTR technique was used to treat periodontal bone defect,

APRF+GTR group

ACTIVE COMPARATOR

GTR technique combined with APRF was used to treat periodontal bone defect

Other: APRF

CGF+GTR group

ACTIVE COMPARATOR

GTR technique combined with CGF was used to treat periodontal bone defect

Other: CGF

Interventions

APRF OTHER

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

APRF+GTR group

CGF OTHER

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

CGF+GTR group

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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);
• Patients took any drug affecting platelet function or had a platelet count less than 200000/mm3 3 months before blood collection.
• Patients have taken antiepileptic drugs, antihistamines, antidepressants, sedatives, sedatives, anti-inflammatory drugs or daily analgesics within 1 month before operation;
• Patients with a history of diabetes or patients with abnormal blood glucose test (fasting blood glucose ≥ 7mmol/L);
• Liver and renal dysfunction (AST, ALT ≥ 1.5 times ULN, creatinine ≥ 1.5 times ULN);
• Patients with severe endocrine and metabolic diseases.
• Those with a history of grade 3 hypertension;
• Those with a history of osteoporosis;
• Those with a history of autoimmune diseases;
• Those with a history of malignant tumor or other serious diseases who are not suitable for surgery or cause observation of tooth loss;
• Pregnant or lactating women;
• Patients with local anesthetic allergy.
• 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
• 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;
• The affected teeth have root furcation lesions

Sponsors & Collaborators

• Second Affiliated Hospital, School of Medicine, Zhejiang University: lead

Study Sites (1)

Lei Lihong

Hangzhou, China

RECRUITING

MeSH Terms

Conditions

Chronic Periodontitis

Condition Hierarchy (Ancestors)

Periodontitis; Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Lihong Lei, associate senior doctor

CONTACT

13989463654; zjullh@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Researcher B is responsible for including the subjects and assigning the number of the subjects according to the order of treatment. During the operation, researcher B will give the sealed envelope to the surgeon L according to the number, then leave, and will not participate in surgery, measurement and other studies. Researcher C is responsible for measuring various indicators on a regular basis. Until the end of the experiment, C did not know the grouping of the subjects.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: This study is a single-center, simple, randomized parallel group design clinical trial in which each random group is allocated according to the proportion of 1:1:1

Study Record Dates

• First Submitted: January 11, 2021
• First Posted: July 7, 2021
• Study Start: August 25, 2020
• Primary Completion: March 1, 2022
• Study Completion: March 1, 2022
• Last Updated: July 7, 2021

Record last verified: 2021-01

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)