Clinical and Patient Outcomes of 4 mm Ultra-Short vs. 8 mm Implants With Bone Augmentation in the Back Upper Jaw

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversitat Internacional de Catalunya

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Inform consent signed.

Adult patients (≥18 years old).

No pregnant women or without the desire to stay.

Periodontal and peri-implant health in a pristine or reduced periodontium.

Disqualifiers

Patients with uncontrolled systemic diseases.

Smoker patients (≥10 cig/day).

Patients taking medications that affect bone metabolism or immunologic disorders.

Patients allergic to penicillin.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Ultra short implants

    Device

    Placement of an ultra short implant of 4mm in the posterior atrophic maxilla without any bone regeneration procedure

  • Long implants with bone augmentation

    Device

    Placement of long implants of 8mm in the posterior atrophic maxilla alongside bone augmentation

Treatment groups

35 Participants
are divided into 2 treatment groups
Group A: ultra-short implantsExperimental treatment 1 intervention
Group B: long implants with bone augmentationOther 1 intervention

Trial outcomes

Primary outcomes

1

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

Time frame
The day of the intervention after the surgery is finalized

Secondary outcomes

1

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

Time frame
at the day of the intervention, since the administration of the anesthesia until the placement of the last suture knot
2

Pain Intensity

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
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
3

Rescue medication

The need to intake rescue medication of Ibuprofen 600mg, Paracetamol 650mg or Amoxicilin 500mg with a nominal response of Yes or No

Time frame
After the surgery during the next 7 days
4

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

Time frame
The day of the surgery

Other outcomes

1

Age

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 and 7 days after the surgery
2

Gender

male/female. Expressed as absolute and relative frequency.

Time frame
The day of the inform consent and selection period
3

Smoking habit

Non-smoker, Smoker ≤ 10 cig per day or Former smoker. Expressed as absolute and relative frequencies.

Time frame
The day of inform consent and selection period
4

Bone density

Subjective evaluation during drilling. Type I, II, III, IV (Lekhom and Zarb, 1986). Expressed as absolute and relative frequencies.

Time frame
The day of the surgery

Locations

This trial has no locations.

Sponsors and contacts

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