Overview
Sponsor-declared trial summary
The medical condition that the patients have in this trial is edentulism in a posterior maxillary quadrant of the mouth with a sinus pneumatisation/ decreased crestal bone heigh defect requiring augmentation and rehabilitation with 1-3 implants. We want to investigate the effect of amoxicillin after this procedure in terms of complications and patient-centered outcomes.
To evaluate the effect of systemic antibiotic administration on postsurgical complications, in patients undergoing oral implant therapy with simultaneous lateral approach sinus floor elevation and guided bone regeneration (GBR).
Key facts
- Sponsor
- Complutense University Of Madrid
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Dentistry [E06]
- Trial duration
- 9 Apr 2025 → ongoing
- Decision date (initial)
- 2025-03-18
- Transition trial
- Yes
- Low-intervention
- Yes
- Rare-disease indication
- No
- Vulnerable population
- No
- Funding sources
- ETEP Research Group · ITI Foundation
External identifiers
- EU CT number
- 2025-521185-10-00
- EudraCT number
- 2021-001885-40
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Therapy
To evaluate the effect of systemic antibiotic administration on postsurgical complications, in patients undergoing oral implant therapy with simultaneous lateral approach sinus floor elevation and guided bone regeneration (GBR).
Secondary objectives 1
- To evaluate the effect of systemic antibiotic administration on postsurgical complications, in patients undergoing oral implant therapy with simultaneous lateral approach sinus floor elevation and guided bone regeneration (GBR).
Conditions and MedDRA coding
The medical condition that the patients have in this trial is edentulism in a posterior maxillary quadrant of the mouth with a sinus pneumatisation/ decreased crestal bone heigh defect requiring augmentation and rehabilitation with 1-3 implants. We want to investigate the effect of amoxicillin after this procedure in terms of complications and patient-centered outcomes.
Regulatory references
- Plan to share IPD
- No
| EU CT number | Title | Sponsor |
|---|---|---|
| 2024-520059-26-00 | The effect of systemic antibiotics on post-surgical complications and patient-centered outomes in patients undergoing implant surgery with the guided bone regeneration and simultaneous sinus floor elevation. | Complutense University Of Madrid |
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 1
- 1. Medically healthy adult (ASA classification I-II), age # 21 years old 2. Non-smoker, previous smoker (quit # 5 years); light smoker with less than 10 cigarettes/ day 3. Not allergic to Amoxicillin/Penicillin antibiotics, NSAIDS or corn-starch 4. Edentulous spaces in the posterior maxilla in one or 2 posterior quadrants with an alveolar bone defect requiring sinus floor elevation and allowing implant placement of up to 3 dental implants and simultaneous GBR (residual crest height 3-5 mm; per implant site (Felice et al. 2012; Park et al. 2019). 5. Absence of signs of pathology of the sinus membrane and acute sinusitis requiring ongoing management
Exclusion criteria 1
- Medically compromised subjects (ASA classification III-V); General contraindications against implant treatment or augmentative procedures (e.g. immunodeficiency, advanced systemic diseases, corticosteroid medication); Those taking Bisphosphonates/anti-angiogenic/RANKL inhibitor medications or receiving local radio-therapy; Heavy smoker or previous heavy smoker (quit < 5 years; ≥ 10 cigarettes/day); Allergic to Amoxicillin or Penicillin antibiotics, NSAIDS and / or corn starch; Use of any form of antibiotics in the last 3 months or subjects requiring regular antibiotic prophylaxis prior to dental treatment; Pregnant or breast feeding. Self-declared intend to conceive (A pregnancy test will be performed for all female patients); Need for 2 stage sinus augmentation; Acute or unmanaged symptomatic sinusitis; Type 1 implant placement (immediate implant placement following extraction); Need for simultaneous soft tissue augmentation; Residual bone height of > 5mm; Subjects aged < 21 years old
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 1
- Patient Reported Outcome Measures (PROMs): Visual analogue scores VAS on the wound (pain, swelling, bruising (haematoma), bleeding) and discomfort of the sinuses (nosebleed, nasal congestion, rhinorrhea (excessive nasal discharge including posterior nasal drip), feeling of pressure, hyposmia (reduction in smell)
Secondary endpoints 1
- Clinical recordings of post-surgical complications: flap closure/dehiscence, purulent discharge, swelling and implant stability and early implant loss.
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 1
AMOXICILINA NORMON 500 mg Cápsulas duras EFG
PRD11781689 · Product
- Active substance
- Amoxicillin
- Substance synonyms
- AMOXICILLINE, AMOXICILLINUM
- Pharmaceutical form
- CAPSULE, HARD
- Route of administration
- ORAL
- Max daily dose
- 4 g gram(s)
- Max total dose
- 21 g gram(s)
- Max treatment duration
- 21 Day(s)
- Authorisation status
- Authorised
- ATC code
- J01CA04 — AMOXICILLIN
- Marketing authorisation
- 62.437
- MA holder
- LABORATORIOS NORMON, S.A.
- MA country
- Spain
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Placebo 1
N/A · Product
- Other product name
- N/A
- Pharmaceutical form
- N/A
- ATC code
- N/A — N/A
- Marketing authorisation
- N/A
- MA holder
- N/A
- MA country
- Iceland
- Paediatric formulation
- No
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Complutense University Of Madrid
- Sponsor organisation
- Complutense University Of Madrid
- Address
- Plaza De Ramon Y Cajal S/N
- City
- Madrid
- Postcode
- 28040
- Country
- Spain
Scientific contact point
- Organisation
- Complutense University Of Madrid
- Contact name
- Mariano Sanz Alonso
Public contact point
- Organisation
- Complutense University Of Madrid
- Contact name
- Mariano Sanz Alonso
Locations
1 EU/EEA country · 1 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Spain | Ongoing, recruiting | 30 | 1 |
| Rest of world | — | 0 | — |
Investigational sites
Country notifications
Trial-start, recruitment-start, end and early-termination notifications submitted per Member State
| Country | Trial start | Trial end | Recruitment start | Recruitment end | Early termination |
|---|---|---|---|---|---|
| Spain | 2025-04-09 | 2025-04-24 |
Results and documents
Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial
Documents 4 files
Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.
| Type | Title | Version |
|---|---|---|
| Protocol (for publication) | Study Protocol SystAB+ Sinus 21_10_2021 | 1 |
| Recruitment arrangements (for publication) | 06_Recruitment_agreement_sinus | 1 |
| Subject information and informed consent form (for publication) | Hoja_info_pac_consent_v3_limpio | 1 |
| Synopsis of the protocol (for publication) | resumen protocolo_2021_10_21 | 1 |
Application history
2 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2025-02-12 | Spain | Acceptable with conditions 2025-02-12
|
2025-03-18 |
| 2 | SUBSTANTIAL MODIFICATION | SM-3 | 2025-03-24 | Spain | Acceptable 2025-04-09
|
2025-04-09 |