Clinical trial NCT06308536: Application of Concentrated Growth Factors in Alveolar Ridge Preservation
Official title: Study on the Effect of Concentrated Growth Factor in Promoting the Regeneration and Preservation of Soft and Hard Tissues
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Alveolar Ridge Preservation
Concentrated Growth Factor
Keywords: extraction site preservation
concentrated growth factor
CGF
soft and hard tissue regeneration
Lead sponsor: The Fourth Affiliated Hospital of Zhejiang University School of Medicine
Sponsor class: OTHER
First posted: 2024-03-13
Enrollment: 20
Sex: ALL
Minimum age (years): 25
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To explore the role of CGF in the regeneration or preservation of soft and hard tissues during tooth extraction site preservation surgery.

Detailed description: A prospective, randomized controlled trial is designed to explore the role of CGF in the regeneration or preservation of soft and hard tissues in extraction site preservation. Using random number table, 20 patients were randomly divided into 4 groups using different filling materials in the extraction socket and materials for the wound sealing. Group A (5cases): bone powder + collagen membrane; Group B (5 cases): bone powder + collagen membrane + CGF membrane; Group C (5 cases): bone powder mixed CGF gel + collagen membrane + CGF membrane; Group D (5 cases): bone powder + CGF membrane.

Extraction and site preservation surgery were performed by the same physician and clinical follow-up was more than 6 months after surgery. The four groups will be compared on several variables, including the changes in pain score, Landry wound healing index, membrane exposure area, keratinized gingival width, buccolingual gingival width, alveolar crest width and height.

Eligibility criteria: Inclusion Criteria:

Voluntarily participate in this trial and sign a written informed consent; Patients aged 25 ≤ age ≤ 45 years; The combination of intraoral and imaging examinations confirms that the affected tooth has no preservation value, requires tooth extraction, and the patient is willing to use site preservation; No progressive periodontal disease or acute apical periodontitis in the affected teeth; No long-term history of oral bisphosphonates; Non smoking patients； No systemic diseases such as diabetes and hypertension.

Exclusion Criteria:

Patients who have difficulty tolerating surgery; Patients under 25 years old or above 45 years old; The whole body is accompanied by hypertension, diabetes and other serious systemic diseases, which need to be controlled by drugs; Patients who take oral medication that affects bone metabolism for at least one month due to the need for disease treatment; Patients who take medication that may affect platelet function was used within 3 months due to the need for disease treatment; Patients unable to undergo X-ray imaging examination due to pregnancy or preparation after site preservation surgery; Patients who Smoke; The apical and periodontal inflammation is in the acute phase (purulent phase) Regular follow-up or follow-up for more than 6 months is not allowed

Primary outcomes:
measure: the width of keratinized gingiva
timeFrame: preoperative, 3 months and 6 months after surgery
measure: the horizontal width (from buccal to lingual at the alveolar top ) of gingiva
timeFrame: immediate , 3 months and 6 months postoperative
measure: the horizontal bone resorption of alveolar crest
timeFrame: immediate , 3 months and 6 months postoperative
measure: the vertical bone resorption of alveolar crest
timeFrame: immediate , 3 months and 6 months postoperative
measure: the average gray value of alveolar bone
timeFrame: immediate , 3 months and 6 months postoperative
Secondary outcomes:
measure: Landry wound healing index
timeFrame: 7 days and 12 days after surgery
measure: reduction in membrane exposure area
timeFrame: 7 days,12 days and one month after surgery
measure: pain score
timeFrame: 1day, 3days after surgerys
Other outcomes:
Locations:
city: Yiwu
country: China
facility: The Fourth Affiliated Hospital Zhejiang University School of Medicine
state: Zhejiang Procince
Study officials:
affiliation: The Fourth Affiliated Hospital Zhejiang University School of Medicine
name: Genying Zhuang, Master
role: STUDY_DIRECTOR
References:
citation: Li S, Yang H, Duan Q, Bao H, Li A, Li W, Chen J, He Y. A comparative study of the effects of platelet-rich fibrin, concentrated growth factor and platelet-poor plasma on the healing of tooth extraction sockets in rabbits. BMC Oral Health. 2022 Mar 23;22(1):87. doi: 10.1186/s12903-022-02126-0.
citation: Tan WL, Wong TL, Wong MC, Lang NP. A systematic review of post-extractional alveolar hard and soft tissue dimensional changes in humans. Clin Oral Implants Res. 2012 Feb;23 Suppl 5:1-21. doi: 10.1111/j.1600-0501.2011.02375.x.