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Clinical Trial on Soft-Tissue Management for Conventional Dental Impressions - Part 2

Clinical Trial on Soft-Tissue Management for Conventional Dental Impressions - Part 2 - WGM II

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
DRKS
Registry ID
DRKS00007809
Enrollment
40
Registered
2015-02-16
Start date
2015-02-23
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

K08.9 K05.0

Interventions

Group 1: Double-cord technique, primary cord: Roeko Retracto, Size 1, imprenated with aluminum-chlorite (Coltène/Whaledent, Langenau), secondary cord: Roeko Retracto, Size 2, non impregnated (Coltène/

Sponsors

Universitätsklinikum Ulm, Zentrum für Zahn-, Mund- und Kieferheilkunde, Klinik für Zahnärztliche Prothetik
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 80 Years

Inclusion criteria

Inclusion criteria: Eligible participants are between 18 and 80 years of age and do not suffer of any chronic or acute infection or disease. Female participants must not be pregnant. Also, there must be no alcohol or drug abusus. Participants should not have known allergies against the materials used in this trial (astrigens, anesthesia, impression material). The periodontal screening index (PSI) has to be equal to or below 2 (no periodontal disease, at the most little calculus on the inside of the lower front teeth). Both premolars and their neighboring teeth are present in the I. and II. quadrant of the upper jaw. Premolars and their neighboring teeth are either healthy or flawlessly restored with circularly at least 1 mm supragingivally located restoration margins. These teeth must not be restored with crowns.

Exclusion criteria

Exclusion criteria: All participants who do not meet the inclusion criteria. Participants who are not fully legally competent. Participants where - if necessary - a short-term restoration of carious lesions according to the following criteria is not possible. Participants with inlays, onlays, partial crowns on teeth 3 to 6 (canine to first molar) of the upper jaw, if restoration margins are not located at least 1 mm supragingival. Participants with crowns on teeth 3 to 6 of the upper jaw with equi- or subgingival margins.

Design outcomes

Primary

MeasureTime frame
The vertical and horizontal sulcus representation in the reference gypsum model compared with the intervention gypsum model after optical digitizing based on the 3D-difference between the computer-aidedly generated border-curves (splines) will be assessed (mm).

Secondary

MeasureTime frame
Persisting gingival recession compared with the base-line impression or the control side after 3, 6, 9, and 12 months

Countries

Germany

Contacts

Public ContactHeike Rudolph

Universitätsklinikum Ulm, Zentrum für Zahn-, Mund- und Kieferheilkunde, Klinik für Zahnärztliche Prothetik

heike.rudolph@computerzaehne.de0731-50064201

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Feb 4, 2026