Skip to content

Comparing dental implant placement with or without bone graft materials in maxillary sinus elevation

Maxillary sinus floor elevation: implant placement with and without grafting materials. a randomized controlled clinical trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN55027167
Enrollment
20
Registered
2025-11-17
Start date
2024-04-29
Completion date
Unknown
Last updated
2025-12-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Atrophic maxilla Oral Health

Interventions

Participants will be randomly allocated into two parallel groups using sealed opaque envelopes prepared by an investigator not involved in surgery. Test group: Sinus floor elevation without grafting

Sponsors

Ardec Academy
Lead Sponsor

Eligibility

Sex/Gender
All
Age
21 Years to 80 Years

Inclusion criteria

Inclusion criteria: 1. Adults aged 21 years or older 2. Patients requiring oral rehabilitation with implants placed in conjunction with maxillary sinus floor elevation 3. Residual bone height = 6 mm 4. Clinically and radiographically healthy maxillary sinuses 5. Ability to obtain adequate primary implant stability in the residual alveolar bone

Exclusion criteria

Exclusion criteria: 1. Presence of any uncontrolled systemic disease 2. Current or past chemotherapy or radiotherapy 3. Smoking >10 cigarettes per day 4. Previous bone regeneration procedures in the area of interest 5. History or presence of maxillary sinus pathology, including: 5.1. Chronic or recurrent sinusitis 5.2. Mucosal cysts or polyps affecting the surgical area 5.3. Ostium obstruction 5.4. Previous sinus surgery 5.5. Sinonasal tumors or structural abnormalities 6. Acute upper respiratory infections at the time of surgery 7. Severe nasal septum deviation compromising sinus ventilation 8. Allergy or contraindication to local anesthetics, antibiotics, or medications required for the procedure 9. Pregnancy or breastfeeding 10. Insufficient oral hygiene or poor compliance expected with follow-up 11. Bruxism or parafunctional habits judged potentially detrimental to implant stability

Countries

Cuba

Contacts

Public ContactDaniele Botticelli
daniele.botticelli@ardec.it+39 333 070450

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026