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Analysis of soft tissue healing over socket orifice sealed with platelet-rich fibrin membrane

Analysis of soft tissue healing over socket orifice sealed with platelet-rich fibrin membrane

Status
Active, not recruiting
Phases
Phase 1Phase 2
Study type
Interventional
Source
TCTR
Registry ID
TCTR20250812006
Enrollment
45
Registered
2025-08-12
Start date
2022-12-09
Completion date
Unknown
Last updated
2026-08-03

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

Conditions

Patients with the need of extraction of upper or lower tooth/teeth due to periodontal disease, deep caries, endodontic complications, radicular fractures, unrestorable restorative reasons, or orthodontic reasons Alveolar ridge preservation, Collagen sponge, L-PRF, Leukocyte and platelet-rich fibrin, Socket sealing surgery

Interventions

L-PRF preparation Patients whole blood was collected at the Faculty of Dentistry, Mahidol University before the surgical procedures. Venous blood from the antecubital vein was drawn with a 21G needle
L-PRF socket sealing,Collagen sponge socket sealing,Spontaneous healing group (Control group)

Sponsors

Faculty of Dentistry, Mahidol University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: 1. In good general health (ASA 1 or 2) with no contraindications for oral surgical procedures, 2. Extraction of upper or lower tooth/teeth due to periodontal disease, deep caries, endodontic complications, radicular fractures, unrestorable restorative reasons, or orthodontic reasons, 3. Presence of adjacent teeth or an implant at the extraction site, 4. Intact buccal bone plate, evaluated intraoperatively immediately after tooth extraction, 5. No history of allergy or hypersensitivity to any products used in the study

Exclusion criteria

Exclusion criteria: 1. History of receiving drugs that influence bone metabolism (e.g., bisphosphonates), 2. History of malignancy, radiotherapy, or chemotherapy for malignancy in the past 5 years, 3. Signs of acute inflammation, infection, or abscess, 4. Uncontrolled or untreated periodontal disease, 5. Smoking >10 cigarettes per day, 6. Inability to undergo radiographic examination, 7. Pregnancy or lactation, 8. Unwillingness to sign the consent form and comply with follow-up visits

Design outcomes

Primary

MeasureTime frame
Wound margin distance reduction percentage Measurements were used to calculate reduction percentage by subtraction baseline (Day 0) to follow-up values (Days 7, 14, 21) and calculate as a percentage. Wound margin distances were measured at the socket midpoint from Bucco-lingual and Mesio-distal aspects using a UNC-15 probe in millimeter (mm).,Postoperative soft tissue healing index Soft tissue healing index was measured at Day 7, 14 and 21 postoperatively. The healing index system was used to assess soft tissue healing including color of tissues, epithelialization of wound margins, presence of bleeding on palpation, granulation and suppuration.,Postoperative pain score Patients recorded pain scores four times daily on surgery day, and Days 1, 3, 5, and 7. Average scores were compared between groups. Postoperative pain was assessed using an 11-point numerical rating scale (NRS-11, 0 means no pain, 10 means severe pain).

Secondary

MeasureTime frame
Wound closure area reduction percentage The percentage of difference in wound area between day 0 and subsequent follow-up visits (Days 7, 14, 21) was defined as the wound closure area reduction percentage. The sockets in both test groups (L-PRF and Collagen sponge group) were scanned using an intraoral scanner and exported as a 3D model and were marked and measured wound area as square millimeters.

Countries

Thailand

Contacts

Public ContactRann Manlerd

Faculty of Dentistry, Mahidol University

manlerd.rann@gmail.com0847240000

Outcome results

None listed

Source: TCTR (via WHO ICTRP) · Data processed: Aug 10, 2026