Sandwich vs. Mixed Bone Augmentation for Implant Placement

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity of California, San Francisco

About this trial

This study is being done to see which of two common grafting techniques-mixing two different grafting materials or layering two grafting materials-works better to augment bone volume next to your dental implant(s). We want to know which technique results in better bone augmentation.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Minimum dentition of 20 permanent teeth

Single edentulous site at maxillary premolar, canine, lateral incisor, or central incisor

Adjacent teeth present with sufficient clearance for an implant crown

Ridge width between 4 mm and 7 mm at the edentulous site

Disqualifiers

Current heavy smokers (>10 cigarettes per day) or heavy smokers who quitted less than 1 year

Pregnancy or lactating mothers

Diseases of the immune system or any medical condition that may influence the treatment outcome (for examples uncontrolled diabetes (HbA1c >7), uncontrolled cardiovascular disease, neurologic or psychiatric disorders, systemic infections, history of radiation therapy in the head and neck area, current use of oral bisphosphonates for >3 years or history of IV bisphosphonates use, current alcoholism or drug abuse, etc.)

Acute infection at/or adjacent to the edentulous site (e.g., sinus tract, swelling, etc.)

Trial design

Design model

Parallel

Treatments tested in this trial

  • Sandwich bone augmentation

    Procedure/Surgery

    The exposed threads on the buccal side of the implant will be grafted with three distinct layers of grafting materials.

  • Mixed bone augmentation

    Procedure/Surgery

    The exposed threads on the buccal side of the implant will be grafted with three grafting materials mixed together.

Treatment groups

30 Participants
are divided into 2 treatment groups
Group A: Sandwich bone augmentationExperimental treatment 1 intervention
Group B: Mixed bone augmentationActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Horizontal Bone Gain (mm) Measured by Cone-Beam Computed Tomography (CBCT)

Horizontal bone gain will be measured in millimeters (mm) by comparing CBCT images obtained at baseline and follow-up. Measurements will be performed using computer-based imaging software to quantify changes in horizontal alveolar ridge width at the treated site.

Time frame
1 year after crown delivery

Secondary outcomes

1

Implant Survival Assessed by Clinical Examination

Implant survival will be assessed by the treating provider through clinical examination at the specified follow-up time point. An implant will be considered surviving if it remains present and in function at the time of evaluation.

Time frame
1 year after crown delivery
2

Pink Esthetic Score (PES) Assessed by a Blinded Examiner

Peri-implant esthetic outcomes will be evaluated by a blinded examiner using the Pink Esthetic Score (PES). The PES will be determined according to the predefined components of the scoring system, with higher scores indicating a more favorable peri-implant soft-tissue esthetic outcome.

Time frame
1 year after crown delivery

Other outcomes

Sponsors and contacts

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This trial is not recruiting at the moment. You can still explore other options: