Efficacy of Socket Grafting for Alveolar Ridge Preservation

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

59 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-03-31

Study Completion Date

2014-10-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

The purpose of this study is to clinically and radiographically assess whether the use of a ridge preservation technique significantly minimizes alveolar ridge resorption following tooth extraction.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Determinants of Bone Dimensional Changes After Extraction and Alveolar Ridge Preservation

NCT06624982

Alveolar Bone Grafting Bone Healing Tooth Extraction Site Healing +1 more

RECRUITING

Alveolar Ridge Preservation Using Autogenous Tooth Graft Versus Autogenous Demineralized Dentin Graft.

NCT03447795

Alveolar Ridge Preservation Dentin Graft Autogenous Tooth Bone Graft

COMPLETED NA

Evaluation of Bone Changes After Immediate Implant Placement or Socket Preservation With or Without Surgical Flap in The Aesthetic Zone

NCT03690973

Alveolar Socket Preservation

COMPLETED PHASE4

Alveolar Ridge Preservation After Tooth Extraction Using Autologous Dentin Matrix

NCT06541236

To Evaluate the Quality of the Newly Formed Cortical Tissue in the Area of the Condylar Condyle Using Different Bone Grafting Materials

RECRUITING NA

Socket Preservation - A Randomized Clinical Implementation in a Student Setting

NCT06539299

Alveolar Bone Loss Dental Implant Bone Augmentation

NOT_YET_RECRUITING NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Subjects requiring single-rooted tooth extractions and future tooth replacement therapy with implant-supported restorations will be recruited. Subjects will be randomly assigned to either a control (tooth extraction alone) or an experimental group (tooth extraction and ridge preservation using an allograft to fill the alveolar socket covered with a non-absorbable, dense polytetrafluoroethylene membrane \[dPTFE\]). Clinical linear measurements of the ridge (horizontal and vertical) will be obtained using a tooth-supported stent. Following extraction, primary closure of the socket will not be attempted. Subjects will be re-evaluated at 1 and 4 weeks. Implant placement surgery will be performed at 16 weeks. Clinical measurements will be repeated upon surgical re-entry. Cone beam computed tomographic (CBCT) scans will be obtained at baseline (after tooth extraction) and at 14 weeks (prior to implant placement) to assess alveolar ridge volumetric changes (primary outcome). Secondary outcome measures include changes in bucco-lingual and apico-coronal clinical measurements of the ridge and changes in modified wound healing index changes overtime. The influence of the thickness of the facial and lingual bone of the alveolar ridge and the width of the keratinized tissue on the remodeling of the ridge will be evaluated.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Atrophy of Edentulous Alveolar Ridge

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Tooth extraction and grafting

Tooth extraction and grafting with allograft

Group Type EXPERIMENTAL

Tooth extraction and grafting with allograft

Intervention Type PROCEDURE

Alveolar ridge preservation using a bone grafting material (allograft) and a synthetic dPTFE (dense Polytetrafluoroethylene) barrier membrane

Tooth extraction

Group Type SHAM_COMPARATOR

Tooth extraction

Intervention Type PROCEDURE

Minimally traumatic single-rooted tooth extraction

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Tooth extraction and grafting with allograft

Alveolar ridge preservation using a bone grafting material (allograft) and a synthetic dPTFE (dense Polytetrafluoroethylene) barrier membrane

Intervention Type PROCEDURE

Tooth extraction

Minimally traumatic single-rooted tooth extraction

Intervention Type PROCEDURE

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Alveolar socket grafting

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Age: 18 to 75 years.
* Gender: No restriction.
* Subjects must require a single-rooted tooth extraction (Tooth deemed as periodontally and/or restoratively hopeless), except lower incisors and second premolars.
* Subjects must be able and willing to follow instructions related to the study procedures.
* Subjects must have read, understood and signed an informed consent form.

Exclusion Criteria

* Reported allergy or hypersensitivity to any of the products to be used in the study.
* Severe hematologic disorders, such as hemophilia or leukemia.
* Active severe infectious diseases that may compromise normal healing.
* Liver or kidney dysfunction/failure.
* Currently under cancer treatment or within 18 months from completion of radio- or chemotherapy.
* Subjects who have a long-term history of oral bisphosphonate use (i.e. 10 years or more).
* Subjects with a history of IV bisphosphonates.
* Subjects with uncontrolled diabetes.
* Subjects with severe metabolic bone diseases, such as Paget's disease of bone, will be excluded.
* Pregnant women or nursing mothers.
* Smokers: Subjects who have smoked within 6 months of study onset.
* Concomitant medications: Subjects on concomitant drug therapy for systemic conditions that may affect the outcomes of the study will not be included in the study.

NOTE: Occasional, short-term use (7-14 days) of analgesics or common cold medications is permitted. Use of such medications will be reviewed and recorded by the investigator.

\- Any other non-specified reason that from the point of views of the investigators will make a candidate not a suitable subject for the study (e.g. limited mouth opening).

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes