Clinical trial NCT06378112: Extraction Socket Augmentation. A Clinical Study
Official title: Extraction Socket Augmentation Using GTO vs. Apatos. A Randomized Controlled Clinical Study
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE4
Conditions: Edentulous Alveolar Ridge With Labial Resorption
Keywords: Bone
Regeneration
Alveolar
Biomaterial
Lead sponsor: Universidad de Granada
Sponsor class: OTHER
First posted: 2024-04-22
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: * 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.
Primary purpose: TREATMENT

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).

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

Primary outcomes:
measure: Dimensional bone changes
timeFrame: 3, 6 and 9 months
Secondary outcomes:
Other outcomes:
Locations:
city: Granada
country: Spain
facility: Dental School
Study officials:
affiliation: Universidad de Granada
name: Manuel Toledano, Professor
role: PRINCIPAL_INVESTIGATOR
References: