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NCT Number: NCT06970184

Alveolar Ridge Preservation With Cortico-cancellous Porcine Bone

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

Active, Not Recruiting

This study is active but is not currently recruiting participants.

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Key information

Conditions

Alveolar Ridge Preservation Implant Therapy Tooth Extraction Site Healing

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

U.O. Odontostomatologia e Chirurgia del Cavo Orale

Pisa, Italy, 56126

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

tooth extraction with alveolar ridge preservation

Procedure

alveolar ridge preservation performed after tooth extraction

implant placement

Procedure

Implant placement

Primary outcomes

  1. Histomorphometric characteristics of the bone: Newly formed bone (NB)

    Time frame: T1= 4 months following tooth extraction + ARP

    The primary outcome is evaluated in terms of Percentages of newly formed bone (NB) in the in the histological samples.

  2. Histomorphometric characteristics of the bone: marrow spaces (MS)

    Time frame: T1= 4 months following tooth extraction + ARP

    The primary outcome is evaluated in terms of Percentages of marrow spaces (MS) in the histological samples

  3. Histomorphometric characteristics of the bone: residual graft particles (RP)

    Time frame: T1= 4 months following tooth extraction + ARP

    The primary outcome is evaluated in terms of Percentages of marrow spaces (MS) in the histological samples

Secondary outcomes

  1. Marginal Bone Level

    Time frame: T1= 4 months following tooth extraction + ARP

    Radiographic marginal bone level (measured in millimeters) taken at the mesial and distal aspect of the implant as the distance from the implant-abutment interface to the most apical bone-implant contact.

  2. Marginal Bone Level

    Time frame: T2= 3 months following implant placement

    Radiographic marginal bone level (measured in millimeters) taken at the mesial and distal aspect of the implant as the distance from the implant-abutment interface to the most apical bone-implant contact.

  3. Marginal Bone Level

    Time frame: T3= 1-year follow-up

    Radiographic marginal bone level (measured in millimeters) taken at the mesial and distal aspect of the implant as the distance from the implant-abutment interface to the most apical bone-implant contact.

  4. Horizontal alveolar measure

    Time frame: Day 1 = tooth extraction + ARP

    Maximum post-extractive buccal/lingual distance (measured in millimeters) of the socket evaluated with a UNC periodontal probe

  5. Horizontal alveolar measure

    Time frame: T1= 4 months following tooth extraction + ARP

    Maximum alveolar crest width at implant placement (measured in millimeters) evaluated with a UNC periodontal probe

  6. Vertical alveolar measure

    Time frame: Day 1 = tooth extraction + ARP

    Mean distance (measured in millimeters) between mesial and distal reference points and the alveolar crest measured with a UNC periodontal probe

  7. Vertical alveolar measure

    Time frame: T1= 4 months following tooth extraction + ARP

    Mean distance (measured in millimeters) between mesial and distal reference points and the alveolar crest measured with a UNC periodontal probe

  8. Aesthetic outcomes

    Time frame: T2= 3 months following implant placement

    evaluated with the Pink Esthetic Score (PES) according to seven variables: mesial papilla, distal papilla, soft tissue level, soft tissue contour, alveolar ridge deficiency, soft tissue color, and soft tissue texture. Each variable could have a score ranging between 0 to 2; the total PES has a maximum level of 14

  9. Aesthetic outcomes

    Time frame: T3= 1-year follow-up

    evaluated with the Pink Esthetic Score (PES) according to seven variables: mesial papilla, distal papilla, soft tissue level, soft tissue contour, alveolar ridge deficiency, soft tissue color, and soft tissue texture. Each variable could have a score ranging between 0 to 2; the total PES has a maximum level of 14

Sponsors and collaborators

Lead sponsor

University of Pisa

Other

Registry information

Official study title

Alveolar Ridge Preservation With Cortico-cancellous Collagenic Porcine Bone

Important dates

Study start
2021
Primary completion
2023
Study completion
2025
First posted
May 14, 2025
Registry last updated
May 20, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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