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

Not Applicable

• Conditions: K08.9; K05.0; Disorder of teeth and supporting structures, unspecified; Acute gingivitis

• Registration Number: DRKS00003374
• Lead Sponsor: niversitätsklinikum UlmDepartment ZahnheilkundeKlinik für Zahnärztliche Prothetik

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Completion: 2011-11-08
• Study Start: 2011-11-30
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 46

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

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

Study & Design

• Study Type: interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
remaining gingival recession (compared to the reference side)