Alveolar Ridge Preservation After Tooth Extraction

NCT06546826 | Active Not Recruiting DMC

• 1 other identifier: 207_2022
• Study Type: observational
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

Post-extractive alveolar ridge remodeling represents a physiological phenomenon that may hamper successive implant insertion. Several techniques have been proposed without any significant difference of efficacy among them. Moreover several research protocols of analysis have been proposed, including histomorphometric, radiological, clinical analysis. The purpose of the present study is to test different alveolar ridge preservation techniques using histomorphometric and optical scanning analysis.

Conditions

Alveolar Bone Loss

Keywords

tooth extraction; implant insertion; post extraction bone remodeling

Outcome Measures

Primary Outcomes (1)

• alveolar volume

  optical scanning comparison

  6 months post-extractive

Secondary Outcomes (1)

• histomorphometric analysis

  6 months post-extraction

Study Arms (4)

BARP

collagen-bonegraft-collagen

Procedure: BARP

unassisted

unassisted healing

Procedure: simple tooth extraction

Tooth root

tooth root and PRF

Procedure: tooth root and PRF

Ice Cream Cone Technique

bonegraft and collagen membrane

Interventions

BARP PROCEDURE

deep layers of collagen, medium-superficial heterologous bone graft, superficial collagen layer

Also known as: Biologically-oriented Alveolar Ridge Preservation

BARP

simple tooth extraction PROCEDURE

tooth extraction without grafting procedure.

unassisted

tooth root and PRF PROCEDURE

Autogenous roots derived from the extracted hopeless tooth and stabilized with osteosynthesis screws to reconstruct the missing buccal wall of the socket. The defect was then filled with PRF.

Tooth root

Ice cream cone technique PROCEDURE

xenogeneic granules and a resorbable collagen membrane

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients needing for tooth extraction and possible implant insertion meeting inclusion and exclusion criteria were eligible

You may qualify if:

• Age between 18 and 80 years;
• Single-rooted tooth with indication for extraction and presenting adjacent teeth;
• Presence of type II defect;
• Sufficient bone height of the extraction site for the insertion of a standard implant (≥8.5 mm);
• Healthy oral mucosa with at least 3 mm of keratinized tissue;
• American Society of Anesthesiologists 3;
• Periodontal health or stability;
• Signature of informed consent.

You may not qualify if:

• Presence of general contraindications for oral surgery;
• Presence of inflammatory and autoimmune diseases;
• Uncontrolled diabetes (HbA1c 7%);
• History of tumors requiring chemotherapy or radiotherapy in the last 5 years;
• Previous therapy with bisphosphonates or high-dose corticosteroid therapy;
• Smoking (10 cigarettes/day);
• Allergy to bovine collagen;
• Pregnancy or breastfeeding;
• Lack of compliance.

Sponsors & Collaborators

• International Piezosurgery Academy: lead
• Universidade do Porto: collaborator
• University of Trieste: collaborator

Study Sites (1)

University of Trieste, Departmen of Medicine, Surgery, Health Sciences

Trieste, Trieste, 34100, Italy

Location

Related Publications (3)

• Pramstraller M, Farina R, Simonelli A, Gotz W, Trombelli L. A Simplified Procedure for Biologically Oriented Alveolar Ridge Preservation: Clinical and Histological Findings From a Case Report. Clin Adv Periodontics. 2021 Dec;11(4):189-194. doi: 10.1002/cap.10120. Epub 2020 Sep 18.

  PMID: 32945629 BACKGROUND

• Schwarz F, Obreja K, Mayer S, Ramanauskaite A, Sader R, Parvini P. Efficacy of autogenous tooth roots for a combined vertical and horizontal alveolar ridge augmentation and staged implant placement. A prospective controlled clinical study. J Clin Periodontol. 2022 May;49(5):496-505. doi: 10.1111/jcpe.13609. Epub 2022 Mar 8.

  PMID: 35258131 BACKGROUND

• Araujo MG, Silva CO, Misawa M, Sukekava F. Alveolar socket healing: what can we learn? Periodontol 2000. 2015 Jun;68(1):122-34. doi: 10.1111/prd.12082.

  PMID: 25867983 BACKGROUND

Biospecimen

Retention: SAMPLES WITH DNA

alveolar bone specimens withdrawn with trephine bur

MeSH Terms

Conditions

Alveolar Bone Loss

Interventions

Prolactin-Releasing Hormone

Condition Hierarchy (Ancestors)

Bone Resorption; Bone Diseases; Musculoskeletal Diseases; Periodontal Atrophy; Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases

Intervention Hierarchy (Ancestors)

Hypothalamic Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Neuropeptides; Peptides; Amino Acids, Peptides, and Proteins; Nerve Tissue Proteins; Proteins

Study Officials

• Claudio Stacchi, Dr.

  University of Trieste, Department of Medicine, Surgery and Health Sciences

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of Scientific committe of International Piezosurgery Academy

Study Record Dates

• First Submitted: August 6, 2024
• First Posted: August 9, 2024
• Study Start: January 6, 2024
• Primary Completion: December 6, 2024
• Study Completion: January 31, 2026
• Last Updated: July 31, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)