Gingival TissueNCT02925078
Influence of Mucosa Tissue Thickness on Marginal Bone Loss of Implants With Smooth Collars
A study testing Biohorizons Tapered Internal Implant, Laser-Lok, Resorbable Blast Textured (RBT) in people with Gingival Tissue, run by University of Michigan at 1 site in United States.
Trial summary
The primary objective of this study is to compare the amount of implant marginal bone loss radiographically and probing depth in between thin and thick mucosa group that will receive a machined collar implant. Null hypothesis is mucosa thickness does not affect implant marginal bone loss on implant with smooth collar. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Gingival Tissue
- What is being tested?
- Biohorizons Tapered Internal Implant, Laser-Lok, Resorbable Blast Textured (RBT)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 21 Nov 2016to 16 Dec 2019
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Male or Female
- Aged ≥18
- In need of one dental implant in the Maxillary or Mandibular area, can be an anterior, premolar, or 1st molar tooth
- Natural adjacent teeth
- Bone height of ≥10mm
- Bone width of ≥5mm
Show all 9Show fewer
- Good oral hygiene
- Stable periodontium
- Willingness to fulfill all study requirements
Who cannot join
- Need bone augmentation
- Need one dental implant that is a 2nd or 3rd molar tooth
- Current smoker or quit smoking less than one year
- Pregnant or plan to get pregnant
- Uncontrolled diabetes (HbA1C > 7)
- Medical conditions that may influence the outcome of the study (neurologic or psychiatric disorders, systemic infections )
Show all 11Show fewer
- Current use of oral bisphosphonates
- History of IV bisphosphonates
- History of radiation therapy in the head and neck area within 4 years
- Poor oral hygiene (plaque score more than 40% based on O'Leary plaque score)
- Once a group has been filled, subjects who meet the criteria of that group will be excluded
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Michigan School of Dentistry
Ann Arbor, Michigan, 48109
About this study
Official title: The Influence of Mucosa Tissue Thickness on Marginal Bone Loss of Implants With Smooth Collars: A Prospective Controlled Trial
The primary objective of this study is to compare the amount of implant marginal bone loss radiographically and probing depth in between thin and thick mucosa group that will receive a machined collar implant.
Null hypothesis is mucosa thickness does not affect implant marginal bone loss on implant with smooth collar.
Read the detailed description
Twenty eight adult patients who fulfill the inclusion criteria will be divided into 2 groups based upon the mucosa thickness (<2 mm and ≥2 mm). A signed written informed consent will be obtained from all subjects. Subjects will not be screened or treated until an informed consent has been obtained. Patient information will be protected according to the privacy regulations of the federal Health Insurance Portability and Accountability Act of 1996 (HIPAA).
The enrolled patients will receive implants with 1 mm polished collar. Implants will be restored at 4 (±1) months after placement. Outcome analyses will be performed until 1 (±1 month) year after loading and clinical and radiographic parameters will be evaluated to compare clinical outcomes between groups. The primary outcome is implant marginal bone loss and probing depth from clinical and radiographic measurements.
- Conditions
- Gingival Tissue
- Being tested
- Biohorizons Tapered Internal Implant, Laser-Lok, Resorbable Blast Textured (RBT)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Biohorizons Tapered Internal Implant, Laser-Lok, Resorbable Blast Textured (RBT)Device
Placement of implant in a subject with <2 mm mucosa thickness or a subject with ≥2 mm mucosa thickness.
| Study group | Role | What they receive |
|---|---|---|
| <2 mm mucosa thickness | Other | A Biohorizons Tapered Internal Implant, Laser-Lok, Resorbable Blast Textured (RBT) will be placed in subjects that have <2 mm mucosa thickness. Receives: Device: Biohorizons Tapered Internal Implant, Laser-Lok, Resorbable Blast Textured (RBT) |
| ≥2 mm mucosa thickness | Other | A Biohorizons Tapered Internal Implant, Laser-Lok, Resorbable Blast Textured (RBT) will be placed in subjects that have ≥2 mm mucosa thickness. Receives: Device: Biohorizons Tapered Internal Implant, Laser-Lok, Resorbable Blast Textured (RBT) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Radiographic Peri-implant Bone Change (Measured in Millimeters) Between Baseline and 12 Months Follow-up.
Radiographic change in remaining bone level (measured in millimeters) between the surgery visit (baseline) and the 12 month follow up visit.
Measured: 12 months
Peri-implant Probing Depth Change (Measured in Millimeters) Between Baseline and 12 Months Follow-up.
Change in probing depths (measured in millimeters) around the dental implant between the crown delivery visit and the 12 month follow-up visit.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Oct 2016 (estimated)
- Study start21 Nov 2016
- Primary completion16 Dec 2019
- Study completion16 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (12)Papers the sponsor has linked to this study.
- Other trials for Gingival TissueStudies of the same condition, open and under way.
- More trials run by University of MichiganThe 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
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Michigan
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hom-Lay Wang, DDS, MSD, Ph D, University of Michigan
- Investigators
- Hom-Lay Wang, DDS MSD PhD, Principal investigator, Department of Periodontics and Oral Medicine University of Michigan School of Dentistry
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02925078
- Sponsor's protocol ID
- HUM00095933
- Status last verified
- Oct 2020
- First submitted
- 3 Oct 2016
- Last updated
- 26 Oct 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Berglundh T, Lindhe J. Dimension of the periimplant mucosa. Biological width revisited. J Clin Periodontol. 1996 Oct;23(10):971-3. doi: 10.1111/j.1600-051x.1996.tb00520.x.
PubMed 8915028Linkevicius T, Apse P, Grybauskas S, Puisys A. The influence of soft tissue thickness on crestal bone changes around implants: a 1-year prospective controlled clinical trial. Int J Oral Maxillofac Implants. 2009 Jul-Aug;24(4):712-9.
PubMed 19885413Balshe AA, Assad DA, Eckert SE, Koka S, Weaver AL. A retrospective study of the survival of smooth- and rough-surface dental implants. Int J Oral Maxillofac Implants. 2009 Nov-Dec;24(6):1113-8.
PubMed 20162117Ochsenbein C, Ross S. A reevaluation of osseous surgery. Dent Clin North Am. 1969 Jan;13(1):87-102. No abstract available.
PubMed 5249439Anderegg CR, Metzler DG, Nicoll BK. Gingiva thickness in guided tissue regeneration and associated recession at facial furcation defects. J Periodontol. 1995 May;66(5):397-402. doi: 10.1902/jop.1995.66.5.397.
PubMed 7623260Claffey N, Shanley D. Relationship of gingival thickness and bleeding to loss of probing attachment in shallow sites following nonsurgical periodontal therapy. J Clin Periodontol. 1986 Aug;13(7):654-7. doi: 10.1111/j.1600-051x.1986.tb00861.x.
PubMed 3531244Abrahamsson I, Berglundh T, Wennstrom J, Lindhe J. The peri-implant hard and soft tissues at different implant systems. A comparative study in the dog. Clin Oral Implants Res. 1996 Sep;7(3):212-9. doi: 10.1034/j.1600-0501.1996.070303.x.
PubMed 9151585Albrektsson T, Zarb G, Worthington P, Eriksson AR. The long-term efficacy of currently used dental implants: a review and proposed criteria of success. Int J Oral Maxillofac Implants. 1986 Summer;1(1):11-25. No abstract available.
PubMed 3527955Peri-implant mucositis and peri-implantitis: a current understanding of their diagnoses and clinical implications. J Periodontol. 2013 Apr;84(4):436-43. doi: 10.1902/jop.2013.134001. No abstract available.
PubMed 23537178Aparna IN, Dhanasekar B, Lingeshwar D, Gupta L. Implant crest module: a review of biomechanical considerations. Indian J Dent Res. 2012 Mar-Apr;23(2):257-63. doi: 10.4103/0970-9290.100437.
PubMed 22945720Wennerberg A, Albrektsson T, Andersson B. Design and surface characteristics of 13 commercially available oral implant systems. Int J Oral Maxillofac Implants. 1993;8(6):622-33.
PubMed 8181824Sabri H, Hazrati P, Tavelli L, Garaicoa-Pazmino C, Calatrava J, Wang HL, Barootchi S. Impact of Peri-Implant Phenotype on Implant Therapy Outcomes: A 5-Year Cohort Analysis on Soft Tissue-Level Implants. J Clin Periodontol. 2026 Mar;53(3):394-406. doi: 10.1111/jcpe.70062. Epub 2025 Dec 12.
PubMed 41387987
Study at a glance
From the registry record, last updated by the sponsor on 26 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Influence of Mucosa Tissue Thickness on Marginal Bone Loss of Implants With Smooth Collars: A Prospective Controlled Trial
- ClinicalTrials.gov ID
- NCT02925078
- Acronym / sponsor ID
- HUM00095933
- Conditions
- Gingival Tissue
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- University of MichiganUniversity, hospital or other
- Study start
- 21 Nov 2016 (actual)
- Primary completion
- 16 Dec 2019 (actual)
- Study completion
- 16 Dec 2019 (actual)
- First posted
- 5 Oct 2016 (estimated)
- Results
- Posted 26 Oct 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The primary objective of this study is to compare the amount of implant marginal bone loss radiographically and probing depth in between thin and thick mucosa group that will receive a machined collar implant.
Null hypothesis is mucosa thickness does not affect implant marginal bone loss on implant with smooth collar.
Detailed description
Twenty eight adult patients who fulfill the inclusion criteria will be divided into 2 groups based upon the mucosa thickness (<2 mm and ≥2 mm). A signed written informed consent will be obtained from all subjects. Subjects will not be screened or treated until an informed consent has been obtained. Patient information will be protected according to the privacy regulations of the federal Health Insurance Portability and Accountability Act of 1996 (HIPAA).
The enrolled patients will receive implants with 1 mm polished collar. Implants will be restored at 4 (±1) months after placement. Outcome analyses will be performed until 1 (±1 month) year after loading and clinical and radiographic parameters will be evaluated to compare clinical outcomes between groups. The primary outcome is implant marginal bone loss and probing depth from clinical and radiographic measurements.
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| <2 mm mucosa thickness | Other | Device: Biohorizons Tapered Internal Implant, Laser-Lok, Resorbable Blast Textured (RBT)A Biohorizons Tapered Internal Implant, Laser-Lok, Resorbable Blast Textured (RBT) will be placed in subjects that have <2 mm mucosa thickness. |
| ≥2 mm mucosa thickness | Other | Device: Biohorizons Tapered Internal Implant, Laser-Lok, Resorbable Blast Textured (RBT)A Biohorizons Tapered Internal Implant, Laser-Lok, Resorbable Blast Textured (RBT) will be placed in subjects that have ≥2 mm mucosa thickness. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Male or Female
- Aged ≥18
- In need of one dental implant in the Maxillary or Mandibular area, can be an anterior, premolar, or 1st molar tooth
- Natural adjacent teeth
- Bone height of ≥10mm
Key exclusion criteria (11 listed)
- Need bone augmentation
- Need one dental implant that is a 2nd or 3rd molar tooth
- Current smoker or quit smoking less than one year
- Pregnant or plan to get pregnant
- Uncontrolled diabetes (HbA1C > 7)
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 |
|---|---|---|
| Biohorizons Tapered Internal Implant, Laser-Lok, Resorbable Blast Textured (RBT)Placement of implant in a subject with <2 mm mucosa thickness or a subject with ≥2 mm mucosa thickness. | Device | <2 mm mucosa thickness, ≥2 mm mucosa thickness |
Primary outcome
Radiographic Peri-implant Bone Change (Measured in Millimeters) Between Baseline and 12 Months Follow-up.
Time frame: 12 months
Radiographic change in remaining bone level (measured in millimeters) between the surgery visit (baseline) and the 12 month follow up visit.
Peri-implant Probing Depth Change (Measured in Millimeters) Between Baseline and 12 Months Follow-up.
Time frame: 12 months
Change in probing depths (measured in millimeters) around the dental implant between the crown delivery visit and the 12 month follow-up visit.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Oct 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 8915028Berglundh T, Lindhe J. Dimension of the periimplant mucosa. Biological width revisited. J Clin Periodontol. 1996 Oct;23(10):971-3. doi: 10.1111/j.1600-051x.1996.tb00520.x.
- Background: PubMed 19885413Linkevicius T, Apse P, Grybauskas S, Puisys A. The influence of soft tissue thickness on crestal bone changes around implants: a 1-year prospective controlled clinical trial. Int J Oral Maxillofac Implants. 2009 Jul-Aug;24(4):712-9.
- Background: PubMed 20162117Balshe AA, Assad DA, Eckert SE, Koka S, Weaver AL. A retrospective study of the survival of smooth- and rough-surface dental implants. Int J Oral Maxillofac Implants. 2009 Nov-Dec;24(6):1113-8.
- Background: PubMed 5249439Ochsenbein C, Ross S. A reevaluation of osseous surgery. Dent Clin North Am. 1969 Jan;13(1):87-102. No abstract available.
- Background: PubMed 7623260Anderegg CR, Metzler DG, Nicoll BK. Gingiva thickness in guided tissue regeneration and associated recession at facial furcation defects. J Periodontol. 1995 May;66(5):397-402. doi: 10.1902/jop.1995.66.5.397.
- Background: PubMed 3531244Claffey N, Shanley D. Relationship of gingival thickness and bleeding to loss of probing attachment in shallow sites following nonsurgical periodontal therapy. J Clin Periodontol. 1986 Aug;13(7):654-7. doi: 10.1111/j.1600-051x.1986.tb00861.x.
- Background: PubMed 9151585Abrahamsson I, Berglundh T, Wennstrom J, Lindhe J. The peri-implant hard and soft tissues at different implant systems. A comparative study in the dog. Clin Oral Implants Res. 1996 Sep;7(3):212-9. doi: 10.1034/j.1600-0501.1996.070303.x.
- Background: PubMed 3527955Albrektsson T, Zarb G, Worthington P, Eriksson AR. The long-term efficacy of currently used dental implants: a review and proposed criteria of success. Int J Oral Maxillofac Implants. 1986 Summer;1(1):11-25. No abstract available.
- Background: PubMed 23537178Peri-implant mucositis and peri-implantitis: a current understanding of their diagnoses and clinical implications. J Periodontol. 2013 Apr;84(4):436-43. doi: 10.1902/jop.2013.134001. No abstract available.
- Background: PubMed 22945720Aparna IN, Dhanasekar B, Lingeshwar D, Gupta L. Implant crest module: a review of biomechanical considerations. Indian J Dent Res. 2012 Mar-Apr;23(2):257-63. doi: 10.4103/0970-9290.100437.
- Background: PubMed 8181824Wennerberg A, Albrektsson T, Andersson B. Design and surface characteristics of 13 commercially available oral implant systems. Int J Oral Maxillofac Implants. 1993;8(6):622-33.
- Derived from this study: PubMed 41387987Sabri H, Hazrati P, Tavelli L, Garaicoa-Pazmino C, Calatrava J, Wang HL, Barootchi S. Impact of Peri-Implant Phenotype on Implant Therapy Outcomes: A 5-Year Cohort Analysis on Soft Tissue-Level Implants. J Clin Periodontol. 2026 Mar;53(3):394-406. doi: 10.1111/jcpe.70062. Epub 2025 Dec 12.
- 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. This study is not recruiting at the moment.
Hom-Lay Wang, DDS MSD PhD principal investigator
Department of Periodontics and Oral Medicine University of Michigan School of Dentistry
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Biohorizons Tapered Internal Implant, Laser-Lok, Resorbable Blast Textured (RBT) in people with Gingival Tissue, run by University of Michigan 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 9 inclusion and 11 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: finished, as of the sponsor's last update on 26 Oct 2020. 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?
Yes. Results are posted in the registry (first posted 26 Oct 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Radiographic Peri-implant Bone Change (Measured in Millimeters) Between Baseline and 12 Months Follow-up. (time frame: 12 months). The study lists 2 primary outcomes in all. 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 NCT02925078, which also lists 12 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 26 Oct 2020.