Comparison of Open-Mouth and Closed-Mouth Impression Techniques for Complete Dentures
Comparison of Open Mouth Vs Closed Mouth Edentulous Impression Technique: A Hospital Based Study
This randomized controlled trial compares two final impression techniques for complete dentures, the open mouth technique and the closed mouth technique. Completely edentulous adults with well-formed ridges will be randomly assigned 1:1 to one of the two techniques. All dentures will be made by a single operator using the same materials and laboratory. Six weeks after insertion, an examiner blinded to group allocation will assess denture retention using the Kapur index, and patient satisfaction will be recorded using a 5-item Likert questionnaire.
Studieoversikt
Status
Forhold
Intervensjon / Behandling
Detaljert beskrivelse
In the open mouth group, border molding and the wash impression are made with the patient's mouth open and no occlusal contact. In the closed mouth group, occlusal rims are attached to the custom trays at a predetermined occlusal vertical dimension, and the impression is made while the patient closes and performs functional movements. Jaw relations, try-in, and insertion follow the same protocol for both groups. Retention is scored separately for the maxillary and mandibular dentures, with a score of 2 or 3 counted as adequate. Satisfaction scores range from 5 to 25, and a score of 16 or above counts as satisfied.
Studietype
Registrering (Antatt)
Fase
- Ikke aktuelt
Kontakter og plasseringer
Studiekontakt
- Navn: Fatima Shakeel, BDS
- Telefonnummer: +92 335 8416673
- E-post: fatimasmir25@gmail.com
Studiesteder
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Punjab Province
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Rawalpindi, Punjab Province, Pakistan, 46000
- Department of Prosthodontics, Watim Medical and Dental College, Rawat, Rawalpindi, Punjab, Pakistan
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Ta kontakt med:
- Fatima Shakeel, BDS
- Telefonnummer: +92 335 8416673
- E-post: fatimasmir25@gmail.com
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Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Beskrivelse
Inclusion Criteria:
- Adults aged 18 to 70 years
- Completely edentulous in both maxilla and mandible for at least six months, confirmed by clinical examination and orthopantomogram
- Well-formed ridges, ACP classification Class I or Class II
Exclusion Criteria:
- Flabby or hypermobile ridges
- Atrophic ridges
- Ridges with bony exostosis
- Active oral pathology
- History of radiotherapy to head and neck
- Uncontrolled systemic disease
- Neuromuscular or neurological disorders
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Enkelt
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
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Aktiv komparator: Group A: Open Mouth Technique
Final impressions made in custom trays with sectional border molding using low fusing impression compound and a zinc oxide eugenol wash, with the mouth open and no occlusal contact. |
Secondary impression of the edentulous arch made in a custom acrylic tray. Border molding is done in sections with low fusing impression compound, followed by a zinc oxide eugenol wash impression. The clinician manipulates the tissues and the patient performs functional movements, with the mouth open and no occlusal contact. All steps are done by a single trained operator using the same materials and laboratory as the comparison group.
Andre navn:
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Aktiv komparator: Group B: Closed Mouth Technique
Final impressions made in custom trays with attached occlusal rims set to a predetermined vertical dimension. Border molding and the wash impression are made while the patient closes into occlusion and performs functional movements. |
Secondary impression made in custom trays with occlusal rims attached and adjusted to a predetermined occlusal vertical dimension. Maxillary and mandibular trays are inserted together. Border molding with low fusing impression compound and a zinc oxide eugenol wash impression are made while the patient closes into occlusion and performs functional movements, recording the denture bearing areas under simulated functional load. All steps are done by a single trained operator using the same materials and laboratory as the comparison group.
Andre navn:
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Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Adequate retention of maxillary denture
Tidsramme: 6 weeks after denture insertion
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Kapur index score (0 nil, 1 poor, 2 fair, 3 good) assessed by a blinded examiner. A score of 2 or 3 is adequate and 0 or 1 is inadequate. |
6 weeks after denture insertion
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Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Adequate retention of mandibular denture
Tidsramme: 6 weeks after denture insertion
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Kapur index score assessed the same way as the maxillary denture. |
6 weeks after denture insertion
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Patient satisfaction
Tidsramme: 6 weeks after denture insertion
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5-item Likert questionnaire covering retention, comfort, mastication, phonetics, and overall satisfaction, with a total score of 5 to 25. A score of 16 or above counts as satisfied. |
6 weeks after denture insertion
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Samarbeidspartnere og etterforskere
Sponsor
Etterforskere
- Hovedetterforsker: Fatima Shakeel, BDS, Watim Medical and Dental College
- Studieleder: Zarah Afreen, BDS, FCPS, Watim Medical and Dental College
Studierekorddatoer
Studer hoveddatoer
Studiestart (Antatt)
Primær fullføring (Antatt)
Studiet fullført (Antatt)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Faktiske)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Andre studie-ID-numre
- WMDC/R&D(ERB)/2025/241
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
IPD-planbeskrivelse
Individual participant data will not be shared publicly to protect participant confidentiality. Summary results will be published in a peer-reviewed journal.
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