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The goal of this randomized clinical trial is to compare biting force and patient satisfaction in three groups. Patients in the control group number one will receive a CoCr removable partial denture, and in the other two groups, implants will be inserted to restore missed posterior teeth (second mandibular premolar and second mandibular molar) in the span area. After three months, implants will be loaded with three units of anatomical PFM-fixed partial dentures in group number two, while in group number three, implants will be loaded with three units of anatomical Zirconia-fixed partial dentures. Biting force will be measured bilaterally at the time of delivery of the removable partial denture and delivery of fixed partial dentures after two, four, and six months. Patient satisfaction will be assessed through a quality-of life questionnaire at the six-months recall appointment
Thirty-three partially edentulous patients will be recruited. Patients will be randomly divided into three groups. Patients in the control group number one will receive a CoCr removable partial denture; in the other two groups, implants will be inserted to restore missed posterior teeth (second mandibular premolar and second mandibular molar) in the span area using a two-stage surgical technique with the help of a radiographic and surgical stent. Pre-surgical and post-surgical prescription of antibiotics, anti-inflammatory drugs, analgesic drugs, and mouthwash for one week, then a follow-up will be done at the suture removal appointment. After a three-month osseointegration period, implants will be loaded with three units of anatomical PFM-fixed partial dentures in group number two, while in group number three, implants will be loaded with three units of anatomical Zirconia-fixed partial dentures. Recall appointments will be scheduled for the patients two, four, and six months after loading for the collection of the data. Biting force will be measured using a biting force sensor for both the intact and restored sides at the time of delivery of the removable partial denture and at the loading of implants after two, four, and six months. Patient satisfaction will be assessed through a quality-of-life questionnaire at the six-months recall appointment.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control group Cobalt Chromium Removable Partial Denture | Active Comparator | The patient will receive a Cobalt Chromium Removable Partial Denture to restore missing posterior teeth in Kennedy Class II cases. The denture will be fabricated by conventional lost-wax and processing techniques. |
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| Implant-Supported Porcelain-Fused-to-Metal-Fixed Partial Denture | Experimental | Two dental implants will be placed to restore missed posterior teeth (second mandibular premolar and second mandibular molar) in Kennedy Class II cases by using a two-stage surgical technique with the help of a radiographic and surgical stent. After a three-month osseointegration period, implants will be loaded with three units of anatomical Implant-Supported Porcelain-Fused-to-Metal-Fixed Partial Denture |
|
| Implant-Supported Zirconia fixed partial denture | Experimental | Two dental implants will be placed to restore missed posterior teeth (second mandibular premolar and second mandibular molar) in Kennedy Class II cases by using a two-stage surgical technique with the help of a radiographic and surgical stent. After a three-month osseointegration period, implants will be loaded with three units of anatomical implant-supported Zirconia fixed partial dentures |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cobalt Chromium Removable Partial Denture | Device | The patient will receive Removable Partial Denture to restore missing teeth in Kennedy Class II cases. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Evaluation of biting force | improvement of Biting force in two different implants supported partial dentures. | Biting force will be measured by newtons unit per minute using a biting force sensor for both the intact and restored sides at the time of delivery of the removable partial denture ( baseline ) and at loading of implants, after 2, 4, and 6 months. |
| Measure | Description | Time Frame |
|---|---|---|
| Oral health-related quality of life ( OHRQoL ) Measurement | OHRQoL was measured by using the original version of the Oral Health Impact Profile OHIP-14, which has been shown to be valid and reliable. The questionnaire included sevendomains-functional limitation, physical pain, psychological discomfort, physical disability, psychological disability, social disability, and handicap-with two questions each. For each item responses were never, hardly ever, occasionally, fairly often and very often. Items were scored on a 5-point scale ranging from 0 (never), to 1 (hardly ever), 2 (occasionally), 3 (fairly often) and 4 (very often) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Ali M Fouda | Contact | 1099662269 | +20 | Ali_fouda97@yahoo.com |
| Name | Affiliation | Role |
|---|---|---|
| Ingy T Lebshtien, PHD | Faculty of Dentistry Ain Shams University | Study Director |
| Noha M El Hussieny, PHD | Faculty of Dentistry Ain Shams University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Faculty of Dentistry, Ain Shams University | Recruiting | Cairo | 11566 | Egypt |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35014207 | Background | Bandiaky ON, Lokossou DL, Soueidan A, Le Bars P, Gueye M, Mbodj EB, Le Guehennec L. Implant-supported removable partial dentures compared to conventional dentures: A systematic review and meta-analysis of quality of life, patient satisfaction, and biomechanical complications. Clin Exp Dent Res. 2022 Feb;8(1):294-312. doi: 10.1002/cre2.521. Epub 2022 Jan 11. | |
| 28042277 |
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IPD that will be published will include the patients' gender, age and the outcome results without disclosing any personal data of the individuals.
The IPD will be available after the end of the study, and it will be available for 12 months after the publication date of the study.
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Control group (1) will receive a CoCr removable partial denture; in the other two groups (2) and (3), implants will be inserted to restore missed posterior teeth (second mandibular premolar and second mandibular molar) in the span area using a two-stage surgical technique with the help of a radiographic and surgical stent. After a three-month osseointegration period, implants will be loaded with three units of anatomical PFM fixed partial dentures in group (2), while in group (3), implants will be loaded with three units of anatomical Zirconia fixed partial dentures. Biting force will be measured using a biting force sensor for both the intact and restored sides at the time of delivery of the removable partial denture and at loading of implants, after 2, 4, and 6 months. Patient satisfaction will be assessed through a quality-of-life questionnaire at the recall appointments.
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|
| Implant-Supported Porcelain-Fused-to-Metal-Fixed Partial Denture | Device | The patient will receive Implant-Supported Porcelain-Fused-to-Metal-Fixed Partial Denture to restore missing teeth in Kennedy Class II cases. |
|
|
| Implant-Supported Zirconia Fixed Partial Denture. | Device | The patient will receive Implant-Supported Zirconia Fixed Partial Denture to restore missing teeth in Kennedy Class II cases. |
|
|
| At the time of delivery of the removable partial denture ( baseline ) and at loading of implants, after 2, 4, and 6 months. Patient satisfaction will be assessed through a quality-of-life questionnaire at the recall appointments. |
| Omnia MS Refai, PHD |
| Faculty of Dentistry Ain Shams University |
| Principal Investigator |
| Ali M Fouda | Faculty of Dentistry Ain Shams University | Principal Investigator |
| Bural C, Buzbas B, Ozatik S, Bayraktar G, Emes Y. Distal extension mandibular removable partial denture with implant support. Eur J Dent. 2016 Oct-Dec;10(4):566-570. doi: 10.4103/1305-7456.195180. |
| 22371834 | Background | Behr M, Zeman F, Passauer T, Koller M, Hahnel S, Buergers R, Lang R, Handel G, Kolbeck C. Clinical performance of cast clasp-retained removable partial dentures: a retrospective study. Int J Prosthodont. 2012 Mar-Apr;25(2):138-44. |
| 21094484 | Background | Erkmen E, Meric G, Kurt A, Tunc Y, Eser A. Biomechanical comparison of implant retained fixed partial dentures with fiber reinforced composite versus conventional metal frameworks: a 3D FEA study. J Mech Behav Biomed Mater. 2011 Jan;4(1):107-16. doi: 10.1016/j.jmbbm.2010.09.011. Epub 2010 Oct 1. |
| 28243301 | Background | Nazari V, Ghodsi S, Alikhasi M, Sahebi M, Shamshiri AR. Fracture Strength of Three-Unit Implant Supported Fixed Partial Dentures with Excessive Crown Height Fabricated from Different Materials. J Dent (Tehran). 2016 Nov;13(6):400-406. |
| 21209994 | Background | Gokcen-Rohlig B, Saruhanoglu A, Cifter ED, Evlioglu G. Applicability of zirconia dental prostheses for metal allergy patients. Int J Prosthodont. 2010 Nov-Dec;23(6):562-5. |
| 22930766 | Background | Pelaez J, Cogolludo PG, Serrano B, Serrano JF, Suarez MJ. A four-year prospective clinical evaluation of zirconia and metal-ceramic posterior fixed dental prostheses. Int J Prosthodont. 2012 Sep-Oct;25(5):451-8. |
| 33898409 | Background | Gu Y, Bai Y, Xie X. Bite Force Transducers and Measurement Devices. Front Bioeng Biotechnol. 2021 Apr 9;9:665081. doi: 10.3389/fbioe.2021.665081. eCollection 2021. |
| ID | Term |
|---|---|
| D009066 | Mouth, Edentulous |
| ID | Term |
|---|---|
| D009059 | Mouth Diseases |
| D009057 | Stomatognathic Diseases |
| D014076 | Tooth Diseases |
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