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This study aims to compare 2 different groups of patients with both a healed site in the upper posterior sector after extractions, one treated with ultra-short implants, and another with long implants with bone regeneration. The objective is to evaluate if short-implants are superior in terms of better clinical outcomes, survival rates and safety, reduced surgical time, postoperative discomfort, and complication risk compared to conventional implants and bone regeneration.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ultra-short implants | Experimental | 4mm long implants |
|
| long implants with bone augmentation | Other | 8mm long implants after transcrestal sinus floor elevation with bone augmentation |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ultra short implants | Device | Placement of an ultra short implant of 4mm in the posterior atrophic maxilla without any bone regeneration procedure |
|
| Measure | Description | Time Frame |
|---|---|---|
| Satisfaction of the surgical procedure | The patient is gonna make a subjective assessment of satisfaction of the surgery once it is finished. For that, we are going to use a 10 centimeter visual analog scale. The extremes of the scale are the extreme expressions of satisfaction, where the extreme left represents a 0 (not satisfied) and 10 (very satisfied). The patient won't have numbers between 0-10 so he will not be influenced by them. Wherever he marks, we will measure it and it will represent in centimeters how was his satisfaction | The day of the intervention after the surgery is finalized |
| Measure | Description | Time Frame |
|---|---|---|
| Surgical time | elapsed time since the administration of local anesthesia until the placement of the last suture knot, with a scale of the exact minutes | at the day of the intervention, since the administration of the anesthesia until the placement of the last suture knot |
| Pain Intensity |
| Measure | Description | Time Frame |
|---|---|---|
| Age | Elapsed time from the birthdate until the date of intervention assignment. Expressed in exact years. | The day of the inform consent and selection period and 7 days after the surgery |
| Gender | male/female. Expressed as absolute and relative frequency. |
inclusion criteria:
exclusion criteria
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| Long implants with bone augmentation | Device | Placement of long implants of 8mm in the posterior atrophic maxilla alongside bone augmentation |
|
Subjective assessment of pain intensity using a 10-cm visual analog scale. The extremes of the scale are the extreme expressions of pain |
| Since the day of the intervention once the surgery is finalized , until the 7th day after the surgery, each day of the following 7 days |
| Rescue medication | The need to intake rescue medication of Ibuprofen 600mg, Paracetamol 650mg or Amoxicilin 500mg with a nominal response of Yes or No | After the surgery during the next 7 days |
| Intra-surgical complications | Any undesired event that happens during the surgical procedure, for example, profuse bleeding, Schneider membrane perforation, by a categorical nominal answer Yes or No | The day of the surgery |
| Post-surgical complications | Any undesired event that happens during the first week of healing | 7 days after the surgery |
| Implant survival | If the implant is present in the mouth regardless of the biological or technical complications. An implant will be considered as failed if explantation is needed for the following reasons: (i) lateral, vertical mobility or rotation; (ii) drastic decrease in the ISQ values over time; (iii) discomfort or pain; and (iv) peri-implant radiolucency compatible with fibrointegration. It will be evaluated in a categorical nominal answer Yes or No | From 10 weeks after surgery to 36 months, after restoration delivery |
| Marginal bone level changes | distance from the mucosal margin to the base of the peri-implant pocket as measured with a PCP UNC 15 periodontal probe. By a mm scale | The day of the surgery, 12 months after and 36 months after |
| Probing pocket depth | distance from the mucosal margin to the base of the peri-implant pocket as measured with a PCP UNC 15 periodontal probe. Scale in mm. | 12 months after surgery and 36 months after surgery |
| Bleeding on probing | : presence or absence of bleeding when performing the peri-implant probing. By a categorical nominal answer Yes or No | 12 months and 36 months after surgery |
| Suppuration on probing | Presence or absence of suppuration when performing the peri- implant probing. By a categorical nominal answer Yes or No | 12 months and 36 months after surgery |
| Keratinized mucosa width | distance from the mucogingival line to the peri-implant mucosal margin in the buccal site as measured with a PCP UNC 15 periodontal probe. In a mm scale | 12 months and 36 months after surgery |
| Soft tissue dehiscence | exposure of any of the abutment or implant components, by a categorical nominal answer Yes or No | 12 months and 36 months after surgery |
| Prosthetic complications | Any undesired event in the prosthetic component (abutment or crown), for example, screw loosening, ceramic chipping | 12 months and 36 months after surgery |
| The day of the inform consent and selection period |
| Smoking habit | Non-smoker, Smoker ≤ 10 cig per day or Former smoker. Expressed as absolute and relative frequencies. | The day of inform consent and selection period |
| Bone density | Subjective evaluation during drilling. Type I, II, III, IV (Lekhom and Zarb, 1986). Expressed as absolute and relative frequencies. | The day of the surgery |
| Full mouth plaque score | Proposed by O'Leary in 1972. Expressed as relative frequency. | 12 months and 36 months after surgery |
| Full mouth bleeding score | Proposed by Ainamo and Bay in 1975. Expressed as relative frequency. | 12 months and 36 months after surgery |
| Crown to implant ratio | Relationship between the crown and the implant length. Measured in periapical radiographs. Expressed as mean and SD/median or IQR. | 6 months after surgery |
| Implant position | 1st or 2nd molar. Expressed as absolute and relative frequency. | The day of Informed consent |
| Primary & secondary implant stability | Based on a resonance frequency analysis (with ISQ values). Expressed as means and SD /median and IQR. | The day of the surgery and 10 weeks after surgery |
| Vertical soft tissue height | Measured with a PCP UNC 15 periodontal probe as the distance from the bone crest to the most coronal portion of keratinized tissue once the buccal flap is raised. Expressed as means and SD /median and IQR. | The day of the surgery |