Influence of the Gingival Condition on the Performance of Different Gingival Displacement Methods—A Randomized Clinical Study
Abstract
:1. Introduction
2. Materials and Methods
2.1. Trial Design
2.2. Participants
- Between 18 and 80 years of age
- Healthy, not suffering from chronic or acute infections or diseases
- No alcohol or drug abuse
- No known allergies to the materials used (astringent, anesthetics, impression material)
- Presence of both premolars in I. and II. quadrants in the upper jaw with their adjacent teeth
- Premolars and adjacent teeth in upper jaw naturally healthy or restored in a defect-free state with restoration margins located at least 1 mm supragingivally
- Legally competent
- Pregnancy
- Smoker
- Upper premolar restored with full-coverage crown
- Periodontal Screening Index (PSI; definition by the German Society for Periodontology) above 2 in at least one sextant
2.3. Interventions
2.3.1. Intervention A
2.3.2. Intervention B
2.4. Outcomes
2.4.1. Sulcus Representation
2.4.2. Marginal Gingiva Height
2.5. Sample Size
2.6. Randomisation
2.7. Blinding
2.8. Statistical Methods
- Point in time (including the gingival condition (healthy/mildly inflamed))
- Tooth (first/second premolar)
- Quadrant (first/second quadrant)
- Intervention (yes/no)
- Gender (female/male)
- GI-value
- PSI-value
- Maximum pocket depth (out of six-point pocket measurements)
3. Results
3.1. Participant Flow
3.2. Recruitment
3.3. Baseline Data
3.4. Numbers Analyzed
- Two values (both premolars) for the control quadrant for B (paste group) at the 3-month follow-up visit after the second intervention.
- Two values (both premolars) for the intervention quadrant for A (cord group) at the 6-month follow-up visit after the second intervention.
- GI value of 2 at the first intervention (A: two probands; B: one proband)
- GI of 1 at the second intervention (A: two probands; B: four probands)
3.5. Outcomes
3.5.1. Sulcus Representation (Primary Outcome), t-Test for Dependent Samples
Influence of an Intervention Performed
Influence of the Gingival Displacement Method
Influence of Gingival Condition
3.5.2. Sulcus Representation (Primary Outcome)-Regression Analysis
Regression Analysis Excluding Cases with Strongly Deviated GI
3.5.3. Marginal Gingiva Height Change (Secondary Outcome)-t-Test for Dependent Samples
3.6. Ancillary Analyses
3.7. Harms
4. Discussion
5. Conclusions
- For healthy gingiva, the cord technique achieved a better gingival displacement in vertical direction (sulcus representation) than the paste technique, with the impression material flowing deeper into the sulcus for the cord technique.
- Mild gingivitis worsened the sulcus representation when using the cord technique but had no influence on the sulcus representation of the paste technique. This means that the advantage of the cord technique with regard to a better sulcus representation was lost to a great extent under the condition of mild gingivitis.
- Neither cord nor paste technique showed—with gentle application in this study—permanent gingival recessions at the palatal study sites up to six months, neither for healthy nor for mildly inflamed gingiva.
Author Contributions
Funding
Institutional Review Board Statement
Informed Consent Statement
Data Availability Statement
Acknowledgments
Conflicts of Interest
References
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Group A (Cord; n = 20) (Mean ± SD) | Group B (Paste; n = 20) (Mean ± SD) | p-Value * | |
---|---|---|---|
Age (baseline) | 25.85 ± 6.82 | 27.40 ± 9.91 | 0.57 (n.s.) |
PSI (baseline) | 1.65 ± 0.49 | 1.55 ± 0.61 | 0.57 (n.s.) |
GI (first intervention, healthy gingiva) | 0.75 ± 0.64 | 0.55 ± 0.61 | 0.32 (n.s.) |
GI (second intervention; artificial gingivitis) | 1.90 ± 0.31 | 1.80 ± 0.41 | 0.39 (n.s.) |
Healthy Gingiva | Artificial Gingivitis | |||||
---|---|---|---|---|---|---|
Gingival Displacement Method (HG: n = 40; AG: n = 40) | Mean Difference [mm] | LL 95%CI | UL 95%CI | Mean Difference [mm] | LL 95%CI | UL 95%CI |
Cord | −0.37 | −0.50 | −0.24 | −0.18 | −0.26 | −0.10 |
Paste | −0.10 | −0.20 | −0.00 | −0.07 | −0.15 | 0.01 |
Group A (Cord; n = 20) HG versus AG | Group B (Paste; n = 20) HG versus AG | |||
---|---|---|---|---|
First premolar | Second premolar | First Premolar | Second Premolar | |
p-value * | 0.02 | 0.07 (n.s.) | 0.37 (n.s.) | 0.74 (n.s.) |
Sulcus Representation | Marginal Gingiva Height Change | |
---|---|---|
Mean RMS Error ± SD | 14.6 µm ± 4.5 | 20.5 µm ± 8.2 |
Percentage of RMS Errors Below the Threshold of 32 µm | 100% | 96.3% |
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Kuhn, K.; Rudolph, H.; Zügel, D.; Just, B.A.; Hrusa, M.; Martin, T.; Schnutenhaus, S.; Dreyhaupt, J.; Luthardt, R.G. Influence of the Gingival Condition on the Performance of Different Gingival Displacement Methods—A Randomized Clinical Study. J. Clin. Med. 2021, 10, 2747. https://doi.org/10.3390/jcm10132747
Kuhn K, Rudolph H, Zügel D, Just BA, Hrusa M, Martin T, Schnutenhaus S, Dreyhaupt J, Luthardt RG. Influence of the Gingival Condition on the Performance of Different Gingival Displacement Methods—A Randomized Clinical Study. Journal of Clinical Medicine. 2021; 10(13):2747. https://doi.org/10.3390/jcm10132747
Chicago/Turabian StyleKuhn, Katharina, Heike Rudolph, David Zügel, Benjamin A. Just, Michael Hrusa, Thomas Martin, Sigmar Schnutenhaus, Jens Dreyhaupt, and Ralph G. Luthardt. 2021. "Influence of the Gingival Condition on the Performance of Different Gingival Displacement Methods—A Randomized Clinical Study" Journal of Clinical Medicine 10, no. 13: 2747. https://doi.org/10.3390/jcm10132747
APA StyleKuhn, K., Rudolph, H., Zügel, D., Just, B. A., Hrusa, M., Martin, T., Schnutenhaus, S., Dreyhaupt, J., & Luthardt, R. G. (2021). Influence of the Gingival Condition on the Performance of Different Gingival Displacement Methods—A Randomized Clinical Study. Journal of Clinical Medicine, 10(13), 2747. https://doi.org/10.3390/jcm10132747