RecruitingPhase 4NCT06378112

Extraction Socket Augmentation. A Clinical Study

Extraction Socket Augmentation Using GTO vs. Apatos. A Randomized Controlled Clinical Study


Sponsor

Universidad de Granada

Enrollment

40 participants

Start Date

May 20, 2022

Study Type

INTERVENTIONAL

Conditions

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).


Eligibility

Min Age: 18 YearsMax Age: 70 Years

Inclusion Criteria10

  • 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 Criteria12

  • ≤ 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

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

DRUGGTO®

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.


Locations(1)

Dental School

Granada, Spain

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

Visit

NCT06378112