Extraction Socket Augmentation. A Clinical Study

NCT06378112 | Recruiting Phase 4

• 1 other identifier: 2734/CEIH/2022
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

Extraction socket preservation is defined as alveolar ridge preservation within the bone envelope remaining after tooth extraction, meanwhile ridge augmentation is defined as increasing the volume of alveolar ridge beyond the bony envelope at the time of tooth extraction. It is recommended to use in cases where extraction socket anatomy is intact. In contrast definition "extraction socket augmentation" defines alveolar ridge restoration when bony walls of the socket are partly or completely lost. In the case of severe loss (\> 50%) of the buccal bone plate, preservation of hard tissue with a prolonged healing time before implant placement has been suggested. The null hypothesis of this experimental work states that: (i) the two different bone graft materials gained the same amount of bone following horizontal ridge augmentation procedure; (i) the two different bone graft materials exhibit similar histological and histomorphometric results Therefore, the main purpose of the current study is to compare two different biomaterials using guided bone regeneration procedures in the ridge preservation/ augmentation (hard-tissue preservation).

Conditions

Edentulous Alveolar Ridge With Labial Resorption

Keywords

Bone; Regeneration; Alveolar; Biomaterial

Outcome Measures

Primary Outcomes (1)

• Dimensional bone changes

  Cone Beam Computed Tomography (CBCT) scans will be performed to each patient to evaluate the dimensional bone changes (height and width): one scan will be made immediately after regenerative surgery, and a second scan will be performed after a postoperative healing period of 6 months (prior to implant placement). Dimensional bone changes will be assessed superimposing and aligning the T0 (after regenerative surgery) and T1 (before implant placement).

  3, 6 and 9 months

Study Arms (2)

Group 1 (test group)

EXPERIMENTAL

Guided bone regeneration procedure with GTO® as bone graft and soft collagenated cortical membrane (OsteoBiol® Lamina; Tecnoss srl) as graft stabilizer.

Drug: GTO®

Group 2 (control)

ACTIVE COMPARATOR

Guided bone regeneration procedure with Apatos Mix® cortico-cancellous heterologous bone mix (OsteoBiol®; Tecnoss srl) as bone graft and soft collagenated cortical membrane (OsteoBiol® Lamina; Tecnoss srl) as graft stabilizer.

Drug: GTO®

Interventions

GTO® DRUG

After teeth extraction, a guided bone regeneration procedure will be performed using a bone graft and a soft collagenated cortical membrane as graft stabilizer. Implant placement surgery will also be performed.

Also known as: Apatos®

Group 1 (test group); Group 2 (control)

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age: ≥ 18 years.
• Good general health.
• Single-tooth implant treatment. Presence of adjacent teeth and opposing occluding teeth (for measurement stent indexing).
• Incisors, canines and premolars.
• Presence of three intact socket walls after tooth extraction with a defect of more than 50% loss of the buccal ridge wall and no fragment of root should be left.
• Reasons for tooth extraction: carious lesion, endodontic complication, root fracture and prosthetic reason.
• Good oral and periodontal health.
• Full-mouth plaque and bleeding \< 20%.
• Able and willing to follow study procedures and instructions.
• Informed consent.

You may not qualify if:

• ≤ 18 years.
• Comprised health. Existence of any systemic condition such as uncontrolled diabetes mellitus, cancer, HIV, disorders that compromise wound healing, chronic high dose steroid therapy, intravenous and oral bisphosphonate therapy, bone metabolic diseases, history of irradiation of the head and neck area, or any other immunosuppressive therapy that would contraindicate oral surgical treatment.
• Absence of any adjacent teeth or the opposing occluding teeth.
• Molars.
• More than one bone wall defect.
• Sinus pathology.
• Allergy or hypersensitivity to medications or any of the products used throughout the study.
• Heavy smokers (defined as \>10 cigarettes per day or \>1 cigar per day) or chew tobacco, including within 3 months prior to enrollment.
• Untreated periodontitis.
• Periapical or periodontal infection.
• Full-mouth plaque and bleeding \> 20%.
• No informed consent

Sponsors & Collaborators

• Universidad de Granada: lead

Study Sites (1)

Dental School

Granada, E18071, Spain

RECRUITING

Study Officials

• Manuel Toledano, Professor

  Universidad de Granada

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Manuel Toledano, Professor

CONTACT

34 958 243788; toledano@ugr.es

Raquel Osorio, Professor

CONTACT

34 958 243789; rosorio@ugr.es

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: * Group 1 (test group): Guided bone regeneration procedure with GTO® as bone graft and soft collagenated cortical membrane (OsteoBiol® Lamina; Tecnoss srl) as graft stabilizer. * Group 2 (control): Guided bone regeneration procedure with Apatos Mix® cortico-cancellous heterologous bone mix (OsteoBiol®; Tecnoss srl) as bone graft and soft collagenated cortical membrane (OsteoBiol® Lamina; Tecnoss srl) as graft stabilizer.

Study Record Dates

• First Submitted: April 17, 2024
• First Posted: April 22, 2024
• Study Start: May 20, 2022
• Primary Completion: January 15, 2025
• Study Completion: December 30, 2025
• Last Updated: April 22, 2024

Record last verified: 2024-04

Locations

ES (1)