Randomized, controlled, clinical trial for evaluation of the influence of platelet rich fibrin (PRF) in combination with bone substitute materials in use for regeneration of extraction sockets

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

DRKS

Registry ID

DRKS00024023

Enrollment

320

Registered

2021-01-21

Start date

2021-03-26

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

Bone- and soft tissue regeneration after tooth extraction K08.1

Interventions

Group 1: Pre-molars - Control 1: unfilled, untreated socket Group 2: Pre-molars: High-RCF-PRF Group 3: Pre-molars - test group 1: socket preservation (type I extraction sockets) or ridge preservation

Eligibility

Sex/Gender

All

Age

18 Years to 98 Years

Inclusion criteria

Inclusion criteria: - informed consent - tooth/teeth in need of extraction - patients planed for dental restoration via implantation - indication for socket preservation / ridge preservation - patients is suitable for two-timed intervention - patient will follow study-related requirements and guidelines

Exclusion criteria

Exclusion criteria: - severe periodontal disease or acute pericoronitis at remaining dentition - mucosal disease in treatment areas - antibiotic treatment - previous augmentation procedures in defect region - uncontrolled diabetes - alcohol abuse - inability to follow post-surgery instructions - inability to attend follow-up visits - insufficiency to follow study-related requirements and guidelines

Design outcomes

Primary

Measure	Time frame
Bone gain in augmented region planned for implantation [3 months post-augmentation]	—

Secondary

Measure	Time frame
- soft tissue healing (score 1-4) [7 days post-augmentation] - implant survival [up to 6 months post-implantation] - bone change in augmented region [3 months post-augmentation] - histological evaluation of vital bone, residual bone substitute material, connective tissue [3 months post-augmentation] - overall soft tissue healing [7 days post-surgery] - Oral Health Impact Profile questionnaire (OHIP-14) [pre-/post-surgery] - peri implant soft tissue and bone tissue changes [up to 6 months post-implantation] - further complications [up to 9 months post-augmentation] - implant-bone connection in follow-up according to radiological evaluation [up to 6 months post-implantation]	—

Measure

Time frame

- soft tissue healing (score 1-4) [7 days post-augmentation] - implant survival [up to 6 months post-implantation] - bone change in augmented region [3 months post-augmentation] - histological evaluation of vital bone, residual bone substitute material, connective tissue [3 months post-augmentation] - overall soft tissue healing [7 days post-surgery] - Oral Health Impact Profile questionnaire (OHIP-14) [pre-/post-surgery] - peri implant soft tissue and bone tissue changes [up to 6 months post-implantation] - further complications [up to 9 months post-augmentation] - implant-bone connection in follow-up according to radiological evaluation [up to 6 months post-implantation]

—

Countries

Germany

Contacts

Public ContactShahram Ghanaati

Universitätsklinikum der Goethe-Universität Frankfurt am Main Klinik für Mund-, Kiefer- und Plastische Gesichtschirurgie

Study-Unit-MKPG@kgu.de+49-69-6301-4492

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Aug 9, 2026