Implant stability in the posterior maxilla: a controlled clinical trial

• Register: ISRCTN
• Last refreshed on: 24 July 2017
• Main ID: ISRCTN33469250
• Date of registration: 22/04/2017
• Prospective Registration: No
• Primary sponsor: University of Porto
• Public title: Implant stability in the posterior maxilla: a controlled clinical trial
• Scientific title: Controlled clinical trial about the effects of bone regeneration in the implant stability during the healing phase
• Date of first enrolment: 01/09/2014
• Target sample size: 60
• Recruitment status: Completed
• URL: http://isrctn.com/ISRCTN33469250
• Study type: Interventional
• Study design: Interventional prospective non-randomised study (Treatment)

Countries of recruitment

Portugal

Contacts

• Name: Raquel Zita Gomes

Key inclusion & exclusion criteria

Inclusion criteria: 1. Aged 18 years and over
2. In good medical and oral condition
3. Need one or more dental implants in the posterior maxilla, for supporting fixed rehabilitations (single crowns or fixed partial prostheses)
4. Willing to fully participate in the study, attending all the requested follow-up sessions
Exclusion criteria: 1. Uncontrolled systemic diseases (uncompensated oral diabetes)
2. History of head/neck irradiation
3. Haemophilia
4. Immune system severe deficiencies
5. On pharmacological therapies that could alter bone metabolism (patients treated with oral/intravenous amino- bisphosphonates)
6. Pregnancy and lactation
7. Smoking >20 cigarettes/day (heavy smokers)

Age minimum:
Age maximum:
Gender: Both

Health Condition(s) or Problem(s) studied

Implant dentistry
Oral Health
Implant dentistry

Intervention(s)

Following provision of informed consent, eligible participants are allocated into one (or more) of three study groups depending on the levels of osseous-regeneration needed in Superior Posterior (SP) area of the maxilla. Implants in the same patient can be of different groups and are always considered as independent. Dental implants placed in different situations of bone regeneration (none, partial, almost total) are therefore examined in this study rather than individual patients. So one patient can be allocated in different groups because he could have different implants placed in different regeneration situations.

Group 1: Patients have a posterior non-regenerated (NR) maxillary bone (healed site) that needs one or more implants. The intervention in this group is the implant placement only (patients received one or more dental implants) with no regeneration prior or concomitant.

Group 2: Patients have a posterior partially regenerated (PR) maxillary bone at the time of implant placement. The interventions on this group is the implant placement and the simultaneous bone regeneration in cases of small bone defects or post extractional implants. The bone graft is done at the surgery of the implant placement.

Group 3: Patients have the necessity of major regeneration with a sinus lift and filling (almost nearly total regenerated (TR) site) healed in the posterior maxilla to permit the implant placement. So the interventions in this group are the bone regeneration of the maxillary sinus (sinus lift and filling) and the implant placement after the healing of the bone graft on the sinus (8 to 10 months).

The study is performed over a period of one year and three months. The cases with sinus lift and filling had at least 8 to 10 months of healing prior to the implant placement. For those in group 3 there is a longer follow up period, because the monitoring is from the bone graft (healing controlled clinically and by X-ray every 3 months) on the sinus until t

Primary Outcome(s)

Dental implants primary stability is assessed using Insertion Torque (IT) and Implant Stability Quotient (ISQ) measurements after implant placement.

Secondary Outcome(s)

Dental implants secondary stability and its progression is asssessed using Implant Stability Quotient (ISQ) at 15, 30, 45 and 60 days.

Secondary ID(s)

University of Oporto Trial Number #890573

Source(s) of Monetary Support

Universidade do Porto