Randomized, controlled, clinical trial for clinical, functional, and histomorphometrical evaluation of bone substitute materials in combination with PRF in use for socket preservation

Randomized, controlled, clinical trial for clinical, functional, and histomorphometrical evaluation of bone substitute materials in combination with PRF in use for socket preservation - Socket Preservation Biomaterial - PRF

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

DRKS

Registry ID

DRKS00019228

Enrollment

Registered

2019-12-30

Start date

2020-10-01

Completion date

Unknown

Last updated

2025-11-24

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: Group 1 - Bone Substitute Material (Ctrl-Group) Group 2: Group 2 - Bone Substitute Material combined with PRF type 1 (Treatment-Group 1) Group 3: Group 3 - Bone Substitute Material combined w

Eligibility

Sex/Gender

All

Age

18 Years to 98 Years

Inclusion criteria

Inclusion criteria: - Age 18 to 98 years - Patients informed consent - One or more tooth/teeth not worth to be preserved - Patients is suitable for two-timed procedure - Patient agrees to follow all study related instructions (eg. instruction regarding oral hygiene, compliance regarding follow-up visits and treatments)

Exclusion criteria

Exclusion criteria: - previous augmentations in the defect area - uncontrolled diabetes (non-compliance regarding physicians instruction for treatment, diet, and/or alcohol consumption; A1c-Level above 8%) - non-compliance regarding study-related instructions - active periodontal disease at the remaining teeth - mucosal disease in defect area

Design outcomes

Primary

Measure	Time frame
Bone gain in augmentation bed / supposed area for implantation	—

Secondary

Measure	Time frame
- Implant survival - Implant success - Change in bone volume in augmentation area / planned implant area - Histological evaluation ratio of: vial bone, residual bone substitute material, connective tissue, further non-bone tissue - Soft tissue healing - Evaluation of oral health via questionnaire (Oral Health Impact Profile questionnaire OHIP-14) - Peri-implant soft tissue and hard tissue changes - Biological or technical complications - Bone-to-implant contact throughout study via radiological parameter	—

Measure

Time frame

- Implant survival - Implant success - Change in bone volume in augmentation area / planned implant area - Histological evaluation ratio of: vial bone, residual bone substitute material, connective tissue, further non-bone tissue - Soft tissue healing - Evaluation of oral health via questionnaire (Oral Health Impact Profile questionnaire OHIP-14) - Peri-implant soft tissue and hard tissue changes - Biological or technical complications - Bone-to-implant contact throughout study via radiological parameter

—

Countries

Germany

Contacts

Public ContactAnja Heselich

Universitätsklinikum derGoethe-Universität Frankfurt am MainKlinik 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: Feb 4, 2026