Ultra short implants
DevicePlacement of an ultra short implant of 4mm in the posterior atrophic maxilla without any bone regeneration procedure
NCT Number: NCT07417293
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.
Trial opening soon.
Get Notified18 year and older
All sexes
Interventional
Not applicable
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Placement of an ultra short implant of 4mm in the posterior atrophic maxilla without any bone regeneration procedure
Placement of long implants of 8mm in the posterior atrophic maxilla alongside bone augmentation
Time frame: The day of the intervention after the surgery is finalized
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
Time frame: at the day of the intervention, since the administration of the anesthesia until the placement of the last suture knot
elapsed time since the administration of local anesthesia until the placement of the last suture knot, with a scale of the exact minutes
Time frame: 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
Subjective assessment of pain intensity using a 10-cm visual analog scale. The extremes of the scale are the extreme expressions of pain
Time frame: After the surgery during the next 7 days
The need to intake rescue medication of Ibuprofen 600mg, Paracetamol 650mg or Amoxicilin 500mg with a nominal response of Yes or No
Time frame: The day of the surgery
Any undesired event that happens during the surgical procedure, for example, profuse bleeding, Schneider membrane perforation, by a categorical nominal answer Yes or No
Time frame: 7 days after the surgery
Any undesired event that happens during the first week of healing
Time frame: From 10 weeks after surgery to 36 months, after restoration delivery
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
Time frame: The day of the surgery, 12 months after and 36 months after
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
Time frame: 12 months after surgery and 36 months after surgery
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.
Time frame: 12 months and 36 months after surgery
: presence or absence of bleeding when performing the peri-implant probing. By a categorical nominal answer Yes or No
Time frame: 12 months and 36 months after surgery
Presence or absence of suppuration when performing the peri- implant probing. By a categorical nominal answer Yes or No
Time frame: 12 months and 36 months after surgery
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
Time frame: 12 months and 36 months after surgery
exposure of any of the abutment or implant components, by a categorical nominal answer Yes or No
Time frame: 12 months and 36 months after surgery
Any undesired event in the prosthetic component (abutment or crown), for example, screw loosening, ceramic chipping
Time frame: The day of the inform consent and selection period and 7 days after the surgery
Elapsed time from the birthdate until the date of intervention assignment. Expressed in exact years.
Time frame: The day of the inform consent and selection period
male/female. Expressed as absolute and relative frequency.
Time frame: The day of inform consent and selection period
Non-smoker, Smoker ≤ 10 cig per day or Former smoker. Expressed as absolute and relative frequencies.
Time frame: The day of the surgery
Subjective evaluation during drilling. Type I, II, III, IV (Lekhom and Zarb, 1986). Expressed as absolute and relative frequencies.
Time frame: 12 months and 36 months after surgery
Proposed by O'Leary in 1972. Expressed as relative frequency.
Time frame: 12 months and 36 months after surgery
Proposed by Ainamo and Bay in 1975. Expressed as relative frequency.
Time frame: 6 months after surgery
Relationship between the crown and the implant length. Measured in periapical radiographs. Expressed as mean and SD/median or IQR.
Time frame: The day of Informed consent
1st or 2nd molar. Expressed as absolute and relative frequency.
Time frame: The day of the surgery and 10 weeks after surgery
Based on a resonance frequency analysis (with ISQ values). Expressed as means and SD /median and IQR.
Time frame: The day of the surgery
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.
Universitat Internacional de Catalunya
Other
Clinical- and Patient-related Outcomes of 4 mm Ultra-short Implants Compared to 8 Mm-long Implants With Bone Augmentation for the Rehabilitation of Posterior Atrophic Maxilla: a Randomized Controlled Clinical Trial.
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.