Peri-implant Bone and Soft TissuesNCT07832565
Sandwich vs. Mixed Bone Augmentation for Implant Placement
A study testing Sandwich bone augmentation and Mixed bone augmentation in people with Peri-implant Bone and Soft Tissues, run by University of California, San Francisco at 1 site in United States.
Trial summary
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 participant's dental implant(s). The investigators want to know which technique results in better bone augmentation. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Peri-implant Bone and Soft Tissues
- What is being tested?
- Sandwich bone augmentation and Mixed bone augmentation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Nov 2026to 31 Dec 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Systemic criteria:
- 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.)
- Intraoral criteria:
- Acute infection at/or adjacent to the edentulous site (e.g., sinus tract, swelling, etc.)
Show all 14Show fewer
- Observable gingival changes due to use of medications such as calcium antagonists, anticonvulsives, immunosuppressants, anti-inflammatory medications, etc.)
- Generalized uncontrolled dental diseases, e.g. caries, periodontal diseases, etc.
- Uncontrolled periodontal disease
- Poor oral hygiene (>20% plaque score)
- CBCT criteria:
- More than 7 mm of alveolar ridge with at the edentulous site present on CBCT scans
- Intraoperative criteria:
- An implant without primary stability >35N
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
Periodontology Clinic, UCSF School of Dentistry
San Francisco, California, 94143
Guo-Hao Lin, DDS, MS, 415-476-1731
About this study
Official title: Comparison of Dental Implant Placement With Simultaneous Sandwich Bone Augmentation vs. Mixed Bone Augmentation: a Randomized Controlled Pilot Study
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 participant's dental implant(s). The investigators want to know which technique results in better bone augmentation.
- Conditions
- Peri-implant Bone and Soft Tissues
- Being tested
- Sandwich bone augmentation, Mixed bone augmentation
- Keywords
- bone dehiscence, bone fenestration, dental implants
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sandwich bone augmentationProcedure or surgery
The exposed threads on the buccal side of the implant will be grafted with three distinct layers of grafting materials.
Mixed bone augmentationProcedure or surgery
The exposed threads on the buccal side of the implant will be grafted with three grafting materials mixed together.
| Study group | Role | What they receive |
|---|---|---|
| Sandwich bone augmentation | Experimental | Not described Receives: Procedure: Sandwich bone augmentation |
| Mixed bone augmentation | Active comparator | Not described Receives: Procedure: Mixed bone augmentation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dental Implant's 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.
Measured: 1 year after crown delivery
Secondary outcomes (2)
Implant Survival Rate 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.
Measured: 1 year after crown delivery
Pink Esthetic Score (PES) of Dental Implant Site 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.
Measured: 1 year after crown delivery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2026
- Study start1 Nov 2026 (estimated)
- Primary completion31 Dec 2028 (estimated)
- Study completion31 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Peri-implant Bone and Soft TissuesStudies of the same condition, open and under way.
- More trials run by University of California, San FranciscoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of California, San Francisco
- Sponsor type
- University, hospital or other
- Collaborators
- Geistlich Pharma AG
- Responsible party
- Sponsor
- Investigators
- Guo-Hao Lin, DDS, MS, Principal investigator, University of California, San Francisco
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07832565
- Sponsor's protocol ID
- 26-46484
- Other IDs
- CA-0285698
- Status last verified
- Oct 2026
- First submitted
- 14 Sep 2026
- Last updated
- 20 Oct 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Buser D, Wittneben J, Bornstein MM, Grutter L, Chappuis V, Belser UC. Stability of contour augmentation and esthetic outcomes of implant-supported single crowns in the esthetic zone: 3-year results of a prospective study with early implant placement postextraction. J Periodontol. 2011 Mar;82(3):342-9. doi: 10.1902/jop.2010.100408. Epub 2010 Sep 10.
PubMed 20831371Wang HL, Misch C, Neiva RF. "Sandwich" bone augmentation technique: rationale and report of pilot cases. Int J Periodontics Restorative Dent. 2004 Jun;24(3):232-45.
PubMed 15227771Buser D, Bragger U, Lang NP, Nyman S. Regeneration and enlargement of jaw bone using guided tissue regeneration. Clin Oral Implants Res. 1990 Dec;1(1):22-32. doi: 10.1034/j.1600-0501.1990.010104.x.
PubMed 2099209
Study at a glance
From the registry record, last updated by the sponsor on 20 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Dental Implant Placement With Simultaneous Sandwich Bone Augmentation vs. Mixed Bone Augmentation: a Randomized Controlled Pilot Study
- ClinicalTrials.gov ID
- NCT07832565
- Acronym / sponsor ID
- 26-46484
- Conditions
- Peri-implant Bone and Soft Tissues
- Keywords
- bone dehiscence, bone fenestration, dental implants
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- University of California, San FranciscoUniversity, hospital or other
- Collaborators
- Geistlich Pharma AG
- Study start
- 1 Nov 2026 (estimated)
- Primary completion
- 31 Dec 2028 (estimated)
- Study completion
- 31 Dec 2028 (estimated)
- First posted
- 22 Sep 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 participant's dental implant(s). The investigators want to know which technique results in better bone augmentation.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sandwich bone augmentation | Experimental | Procedure: Sandwich bone augmentation |
| Mixed bone augmentation | Active comparator | Procedure: Mixed bone augmentation |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (14 listed)
- Systemic criteria:
- Intraoral criteria:
- CBCT criteria:
- Intraoperative criteria:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Sandwich bone augmentationThe exposed threads on the buccal side of the implant will be grafted with three distinct layers of grafting materials. | Procedure or surgery | Sandwich bone augmentation |
| Mixed bone augmentationThe exposed threads on the buccal side of the implant will be grafted with three grafting materials mixed together. | Procedure or surgery | Mixed bone augmentation |
Primary outcome
Dental Implant's Horizontal Bone Gain (mm) Measured by Cone-Beam Computed Tomography (CBCT)
Time frame: 1 year after crown delivery
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.
2 secondary outcomes
Implant Survival Rate Assessed by Clinical Examination
Time frame: 1 year after crown delivery
Pink Esthetic Score (PES) of Dental Implant Site Assessed by a Blinded Examiner
Time frame: 1 year after crown delivery
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Oct 2026.
- Background: PubMed 20831371Buser D, Wittneben J, Bornstein MM, Grutter L, Chappuis V, Belser UC. Stability of contour augmentation and esthetic outcomes of implant-supported single crowns in the esthetic zone: 3-year results of a prospective study with early implant placement postextraction. J Periodontol. 2011 Mar;82(3):342-9. doi: 10.1902/jop.2010.100408. Epub 2010 Sep 10.
- Background: PubMed 15227771Wang HL, Misch C, Neiva RF. "Sandwich" bone augmentation technique: rationale and report of pilot cases. Int J Periodontics Restorative Dent. 2004 Jun;24(3):232-45.
- Background: PubMed 2099209Buser D, Bragger U, Lang NP, Nyman S. Regeneration and enlargement of jaw bone using guided tissue regeneration. Clin Oral Implants Res. 1990 Dec;1(1):22-32. doi: 10.1034/j.1600-0501.1990.010104.x.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Guo-Hao Lin, DDS, MS principal investigator
University of California, San Francisco
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Sandwich bone augmentation and Mixed bone augmentation in people with Peri-implant Bone and Soft Tissues, run by University of California, San Francisco at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 20 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Guo-Hao Lin, DDS, MS (415-476-1731, guo-hao.lin@ucsf.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Dental Implant's Horizontal Bone Gain (mm) Measured by Cone-Beam Computed Tomography (CBCT) (time frame: 1 year after crown delivery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07832565, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Oct 2026.