Clinical trial NCT06970184: Alveolar Ridge Preservation With Cortico-cancellous Porcine Bone
Official title: Alveolar Ridge Preservation With Cortico-cancellous Collagenic Porcine Bone
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Alveolar Ridge Preservation
Implant Therapy
Tooth Extraction Site Healing
Keywords: ARP
tooth extraction
dental implants
porcine bone
collagen
Lead sponsor: University of Pisa
Sponsor class: OTHER
First posted: 2025-05-14
Enrollment: 22
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients requiring hopeless tooth extraction followed by ARP and implant-prosthetic rehabilitation

Brief summary: Observational, prospective study conducted on patients requiring tooth extractions followed by ARP and subsequent implant placement.

Detailed description: The primary aim of this study is to compare the histomorphometric characteristics of two different formulations of CCPB used for ARP, and the secondary aim is to evaluate and compare clinical and aesthetic outcomes of dental implants placed in augmented sites.

Patients requiring the extraction of an hopeless tooth followed by ARP and subsequent implant placement are considered potentially eligible for the study.

At T0, Tooth extractions are performed trying to reduce the surgical trauma as possible. ARP is performed with 2 different combinations of a cortico-cancellous porcine bone with a thermogel (50:50 ratio, hand-mixed or 80:20 ratio, pre-mixed).

After 4 months of healing, patients undergo a radiographic examination before implant placement.

A T1, Implant site preparation is carried out using a trephine bur (to remove a core biopsy of the bone) followed by conventional osteotomy drills, and bone-level implants are placed. Bone samples are analyzed to evaluate new bone formation, presence of residual graft particles and marrow spaces.

Three months after placement, all implants are rehabilitated with screw-retained prosthetic crowns (T2).

Follow up is scheduled 1 year after prosthetic loading (T3).

Eligibility criteria: Inclusion Criteria:

* 18 yo
* Needing tooth extraction followed by ARP and implant-prosthetic rehabilitation

Exclusion Criteria:

* uncontrolled systemic diseases
* uncontrolled periodontitis
* undergoing previous or actual treatment with medications/radiations potentially impairing hard and soft tissues healing
* women during pregnancy or breastfeeding

Primary outcomes:
measure: Histomorphometric characteristics of the bone: Newly formed bone (NB)
timeFrame: T1= 4 months following tooth extraction + ARP
measure: Histomorphometric characteristics of the bone: marrow spaces (MS)
timeFrame: T1= 4 months following tooth extraction + ARP
measure: Histomorphometric characteristics of the bone: residual graft particles (RP)
timeFrame: T1= 4 months following tooth extraction + ARP
Secondary outcomes:
measure: Marginal Bone Level
timeFrame: T1= 4 months following tooth extraction + ARP
measure: Marginal Bone Level
timeFrame: T2= 3 months following implant placement
measure: Marginal Bone Level
timeFrame: T3= 1-year follow-up
measure: Horizontal alveolar measure
timeFrame: Day 1 = tooth extraction + ARP
measure: Horizontal alveolar measure
timeFrame: T1= 4 months following tooth extraction + ARP
measure: Vertical alveolar measure
timeFrame: Day 1 = tooth extraction + ARP
measure: Vertical alveolar measure
timeFrame: T1= 4 months following tooth extraction + ARP
measure: Aesthetic outcomes
timeFrame: T2= 3 months following implant placement
measure: Aesthetic outcomes
timeFrame: T3= 1-year follow-up
Other outcomes:
Locations:
city: Pisa
country: Italy
facility: U.O. Odontostomatologia e Chirurgia del Cavo Orale
Study officials:
References: