Clinical study evaluating the survival and success rates of two dental implants with a narrow diameter made of a titanium-zirconium alloy supporting a dental bridge

• Register: ISRCTN
• Last refreshed on: 11 September 2023
• Main ID: ISRCTN23651018
• Date of registration: 28/11/2017
• Prospective Registration: No
• Primary sponsor: Universitat Internacional de Catalunya
• Public title: Clinical study evaluating the survival and success rates of two dental implants with a narrow diameter made of a titanium-zirconium alloy supporting a dental bridge
• Scientific title: Prospective clinical study of Straumann NNC dental implants for the treatment of partially edentulous patients
• Date of first enrolment: 15/09/2012
• Target sample size: 30
• Recruitment status: Completed
• URL: https://www.isrctn.com/ISRCTN23651018
• Study type: Observational
• Study design: Prospective clinical trial of a cohort study with a follow-up from 1 year to 5 years (Treatment)
• Phase: Not Applicable

Countries of recruitment

Spain

Contacts

• Name: Pablo Altuna

Key inclusion & exclusion criteria

Inclusion criteria: 1. Patients =18 years of age
2. Patients in need of multiple teeth restoration in the maxilla or mandible, of incisors, canines and bicuspids
3. Patients with narrow ridges where conventional implants with a diameter of 4.1 mm cannot be used (< 6 mm)
4. Patients with a full mouth plaque according to O’Leary = 25% at time of surgery
Exclusion criteria: 1. Patients with any conditions or circumstances which would interfere with the requirements for oral surgery
2. Patients allergic to any implant metallic component
3. Patients needing major bone regeneration techniques
4. Patients where the ridge allows the restoration with a conventional implant diameter of 4.1 mm

Age minimum:
Age maximum:
Gender: Both

Health Condition(s) or Problem(s) studied

Partially edentulous patients, missing 3 or four teeth in both jaws
Oral Health

Intervention(s)

Thirty patients with partial edentulism (missing 3 or 4 teeth from second premolar to second premolar of both jaws) will be recruited for the study at the School of Dentistry’s Clinic, Universitat Internacional de Catalunya, Barcelona. Two titanium-zirconium alloy (Roxolid (R)) narrow-diameter implants will be placed in each patient under local anesthesia. Rehabilitation with a bridge of 3 or 4 crowns. Only minor bone regeneration or soft tissue grafting would be performed if needed. The crowns would be placed after at least 8 weeks of healing.

Primary Outcome(s)

Success and survival rate of Straumann NNC implants 12 months after final restoration:
1. The success rate will be assessed according to the criteria of Buser (Buser et al., 1991):
1.1. No detectable clinical mobility (hand testing)
1.2. No radiolucency surrounding the total surface of the implant
1.3. No persistent pain refractory to medical therapy
1.4. No recurrent peri-implant infection
2. A surviving implant is an implant that is in place at the time of evaluation

Secondary Outcome(s)

Measured after 1 year, 3 years and 5 years:
1. Radiological measurements of the crestal bone level (mesial and distal), with bite registration and paralleling technique
2. Patient satisfaction and dentist satisfaction, measured using VAS
3. Periodontal evaluation: clinical attachment level, bleeding on probing, plaque index, pocket probing depth
4. Vestibular bone stability, measured using a small field CBCT
4. Survival, success and complications of the prostho treatment

Secondary ID(s)

IMP-ECL-2012-01

Source(s) of Monetary Support

Universitat Internacional de Catalunya, Institut Straumann AG (Switzerland)

Ethics review

Status:
Approval date:
Contact:

Old ethics approval format; Ethics board of Clinical Investigations of the Faculty of Dentistry, Universitat Internacional de Catalunya (Comitè Ètic d'Investigació Clínica (CEIC) of the Clinica Universitària d'Odontologia (CUO), Universitat Internacional de Catalunya, Barcelona), 16/07/2012, ref: IMP-ECL-2012-01

Results

• Results available: Yes
• Date Completed: 20/07/2021