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Randomized controlled clinical trial on the ridge preservation with the combination of collagen cone and collagen membrane „Sombrero“ successive to tooth extraction in comparison to a control group

Randomized controlled clinical trial on the ridge preservation with the combination of collagen cone and collagen membrane „Sombrero“ successive to tooth extraction in comparison to a control group - Sombrero

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
DRKS
Registry ID
DRKS00004769
Enrollment
60
Registered
2013-02-28
Start date
2013-03-04
Completion date
Unknown
Last updated
2025-04-07

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

Conditions

K08.1

Interventions

Group 1: The test group patients will receive a collagen cone, which is placed into the empty socket after tooth extraction. The wound will be covered with a collagen membrane. Cone and membrane will

Sponsors

Universitätsklinikum Ulm /Studienleiter: Prof. Dr. Ralph G. Luthardt, Klinik für Zahnärztliche Prothetik
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: Patients with at least one tooth that has to be extracted in the upper jaw. Reasons for extraction can be periodontal destruction or destruction due to caries or trauma, which precludes tooth preservation. Planned treatmant has to be implant insertion. Precondition for patients in both groups is a tooth or an existing implant as direct neighbor to the tooth to be extracted.

Exclusion criteria

Exclusion criteria: • Persons under the age of 18 and accordingly persons who are not legally competent • Visibel primary need for bone augmentation • Implant insertion through the implant template impossible (insufficient mouth opening) • Heavy smokers (more than 10 cigarettes/day) • Intake of bisphosphonate medication • Pregnant women • Alcohol or drug addicts • Patients with infectious diseases such as hepatitis or HIV/AIDS • Patients with an ill balanced severe diabetes mellitus. The long-term value for blood sugar HbA1c has to be below 6,7 %

Design outcomes

Primary

MeasureTime frame
Primary outcome is the metrically assessed bone preservation after 8 weeks at the time of the implant position planning. For this purpose the digitized impression data of the extraction wound will be aligned to the 3D x-ray (cone-beam computer tomography) and the difference in volume will be calculated using CAD-software.

Secondary

MeasureTime frame
Secondary outcomes are patient satisfaction (measured with a visual analogue scale, VAS) at the time of suture removal and examination 7 days after tooth extraction, the qualitative histological analysis of the newly grown bone (11 weeks after tooth extraction, immediately before implatation) and the added value in relation to costs (at the end of the treatment, seating of the restoration).

Countries

Germany

Contacts

Public ContactSigmar Schnutenhaus

Zahnarztpraxis

info@schnutenhaus.de+49 (0) 7731 182755

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Mar 6, 2026