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Clinical cross-over study on soft-tissue management in impressions

Clinical cross-over study on soft-tissue management in impressions - WGM-I

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
DRKS
Registry ID
DRKS00003374
Enrollment
40
Registered
2011-11-30
Start date
2009-07-09
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 Group 2: aluminum chlorite containing kaolin paste

Sponsors

Universitätsklinikum Ulm Department Zahnheilkunde Klinik für Zahnärztliche Prothetik
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 80 Years

Inclusion criteria

Inclusion criteria: The probands should be healthy and between 18 and 80 years, do not suffer from chronic or acute infections or diseases; female probands should not be pregnant. Furthermore, alcohol or drug abuse may not be existent. Suituable probands do not have any known allergies against the materials used (astringent, anesthetic, impression material). The PSI (periodontal screening index) is 2 or less (= no periodontal disease, a little calculus in the lower front at most). Both premolars in the 1st and 2nd quadrant as well as the adjacent teeth are present. The premolars and the adjacent teeth are either healthy and untreated or perfectly restored where the complete restoration margins are at least 1 mm above the gingiva; crowns were excluded.

Exclusion criteria

Exclusion criteria: All probands, who do not fulfill the criteria for inclusion Probands, where a short-term restoration was impossible or where the complete healing before the end of the intervention phase of the study was not guaranteed Probands with inlays, onlays, or partial crowns at teeth Nos. 3 – 6 in the maxilla with margins of less than 1 mm above the gingiva Probands with crowns at teeth Nos. 3 – 6 in the maxilla with equigingival or subgingival margins Smokers Probands after an orthodontic extraction therapy of maxillary premolars since both premolars in both quadrants of the maxilla are required

Design outcomes

Primary

MeasureTime frame
The 3D differences between the sulcus representation in the reference gypsum model compared to the intervention gypsum model are calculated after digitizing and the computer-aided making of sulcus splines (µm). First healthy tissue conditions are tested and after 6 months artificial gingivitis conditions. The evaluation is made immediately after the intervention.

Secondary

MeasureTime frame
remaining gingival recession (compared to the reference side)

Countries

Germany

Contacts

Public ContactHeike Rudolph

Universitätsklinikum Ulm Department Zahnheilkunde Klinik für Zahnärztliche Prothetik

heike.rudolph@computerzaehne.de0731-50064201

Outcome results

None listed

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