Extraction Socket Augmentation. A Clinical Study

NCT ID: NCT06378112

Last Updated: 2024-04-22

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE4
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-05-20
• Study Completion Date: 2025-12-30

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).

Detailed Description

Patients needing teeth extraction and unitary implant placement will be recruited at the Dental School of the University of Granada (Máster de Cirugía Bucal).

Two study groups will be stated:

• 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.

All employed Materials are commercially available and are completely approved to be used in humans. They are currently being used in dental practice in Europe, U.S.A. and many other countries. Eurofins Product Testing Italy S.r.l certifies that the manufacturer's full quality assurance system is compliant with Annex II of 93/42/EEC Medical Devices Directive and subsequent amenaments and upgrades (Certificate No. EPT0477.MDD.19/3209.1).

Conditions

Edentulous Alveolar Ridge With Labial Resorption

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

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 Type: EXPERIMENTAL

GTO®

Intervention Type: 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.

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.

Group Type: ACTIVE_COMPARATOR

GTO®

Intervention Type: 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.

Interventions

GTO®

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.

Intervention Type: DRUG

Other Intervention Names

Apatos®

Eligibility Criteria

Inclusion Criteria

• 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.

Exclusion Criteria

• ≤ 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Universidad de Granada

OTHER

Sponsor Role: lead

Responsible Party

Manuel Toledano

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Manuel Toledano, Professor

Role: PRINCIPAL_INVESTIGATOR

Universidad de Granada

Locations

Dental School

Granada, , Spain

Site Status: RECRUITING

Countries

Spain

Central Contacts

Manuel Toledano, Professor

Role: CONTACT

toledano@ugr.es

34 958 243788

Raquel Osorio, Professor

Role: CONTACT

rosorio@ugr.es

34 958 243789

Facility Contacts

Manuel Toledano, Professor

Role: primary

toledano@ugr.es

Raquel Osorio

Role: backup

rosorio@ugr.es

Other Identifiers

2734/CEIH/2022

Identifier Type: -

Identifier Source: org_study_id