Dental Implant Soft Tissue Defects in the Anterior MaxillaNCT01934530
A Randomized Control Trial Testing Connective Tissue Grafts vs. Allograft on Dental Implants
A study testing Soft Tissue Grafting in people with Dental Implant Soft Tissue Defects in the Anterior Maxilla, run by University of Michigan at 1 site in United States.
Trial summary
This randomized controlled clinical pilot trial compared the efficacy of two soft tissue grafting methods for correcting esthetic discrepancies associated with non-molar implants in the maxilla. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Dental Implant Soft Tissue Defects in the Anterior Maxilla
- What is being tested?
- Soft Tissue Grafting
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 13 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2009to Jul 2012
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
- Healthy adults of at least 18 years of age
- Maxillary non-molar implant with failing pink esthetic profile
- Implants with adjacent landmarks (only one can be an implant)
- Healthy implants measured by the lack of peri-implantitis and mucositis
- Good oral hygiene.
Who cannot join
- Unstable systemic diseases, compromised immune system, or unstable bleeding disorders
- History of radiation or cancer in the oral cavity
- Use of IV bisphosphonate or steroid medication
- Use of tobacco products (>1/2 pack per day)
- Pregnancy
- Mucogingival surgery or implant placement within the past six months
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Implant Associated Soft Tissue Defects in the Anterior Maxilla: A Randomized Control Trial Between Subepithelial Connective Tissue Graft and Acellular Dermal Matrix Allograft
This randomized controlled clinical pilot trial compared the efficacy of two soft tissue grafting methods for correcting esthetic discrepancies associated with non-molar implants in the maxilla. Specifically, it was explored whether defects treated with connective tissue grafts (SCTG) differed in their outcomes from defects treated with acellular dermal matrix allografts (ADM).
Read the detailed description
Thirteen patients who presented with implants displaying recession, thin biotype, concavity defects or a combination thereof associated with single crowned dental implants participated in this randomized control trial. The control group (N=7) received SCTG and the test group (N=6) received ADM, both under coronally positioned flaps. Data were collected before surgery, and 6 weeks, 3 months, and 6 months after the surgery. Outcome measures included soft tissue, hard tissue, and esthetics parameters and psychosocial data.
- Being tested
- Soft Tissue Grafting
- Keywords
- implant complications, esthetics, soft tissue grafting
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Soft Tissue GraftingProcedure or surgery
All patients were treated with infiltration of local anesthetic with vasoconstrictor if noted tolerable by the medical history. Surgeons were then notified if the patient was randomized to the test or control according to a blinded treatment assignment. In both groups, anesthesia was confirmed at the implant site and the palatal donor site if indicated. The recipient bed was then prepared.
Vertical incisions were made at the defect at line angles and horizontal incisions connected the two vertical releases intrasulcularly without involving the interdental papilla. The flap was reflected as a full thickness flap maintaining the integrity of the collagen attachment with de-epithelialization of papilla to allow for coronal advancement.
| Study group | Role | What they receive |
|---|---|---|
| Connective Tissue Graft - Control | Active comparator | The donor tissue was harvested from tissue palatal to maxillary premolars and anterior to the mesial of the first molars. A horizontal incision corresponding to the width of the recipient bed plus 4mm was made 3 mm apical to the gingival margin. A small secondary vertical incision was tolerated on the mesial aspect of the surgical site to allow for a split thickness technique. The flap was then positioned over the graft and sutured with attempts to cover the grafted tissue to 2mm coronal to the implant/abutment interface pending flap tension. Follow up was monitored over 6 months at various time-points. Receives: Procedure: Soft Tissue Grafting |
| Alloderm - Test | Experimental | ADM graft was prepared according to the manufacturer's instructions. The preparation requires rehydration in 50ml sterile saline or Ringers Solution for five minutes and repeated twice. The graft was then transferred to the recipient bed with the basement membrane side facing up and connective tissue on the periosteum. The allograft was trimmed to cover the defect dimensions up to the implant-abutment interface. There was a 4mm margin added to the width on each side to account for lateral contraction as with the connective tissue. With sterile moist gauze, pressure was applied to the graft for proper adaptation to the wound bed. The graft was sutured with a single sling and the flap with a double sling. Simple interrupted sutures were used to close vertical releases. Receives: Procedure: Soft Tissue Grafting |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recession Correction
Change in recession was recorded at baseline, 6 weeks, 3 months and 6 months after grafting.
Measured: 6 Months
Secondary outcomes (1)
Concavity Correction
At baseline, 6 weeks, 3 months, and 6 months after grafting, buccal concavities were measured.
Measured: 6 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Sep 2013 (estimated)
- Study startAug 2009
- Primary completionMay 2012
- Study completionJul 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dental Implant Soft Tissue Defects in the Anterior MaxillaStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 13 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Michigan
- Sponsor type
- University, hospital or other
- Collaborators
- BioHorizons, Inc.
- Responsible party
- Sponsor
- Investigators
- Hom-Lay Wang, DDS, MS, PhD, Study chair, University of Michigan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01934530
- Sponsor's protocol ID
- UM-Anderson-10
- Status last verified
- Feb 2017
- First submitted
- 29 Aug 2013
- Last updated
- 10 Feb 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Implant Associated Soft Tissue Defects in the Anterior Maxilla: A Randomized Control Trial Between Subepithelial Connective Tissue Graft and Acellular Dermal Matrix Allograft
- ClinicalTrials.gov ID
- NCT01934530
- Acronym / sponsor ID
- UM-Anderson-10
- Keywords
- implant complications, esthetics, soft tissue grafting
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 13 participants (actual)
- Lead sponsor
- University of MichiganUniversity, hospital or other
- Collaborators
- BioHorizons, Inc.
- Study start
- Aug 2009
- Primary completion
- May 2012 (actual)
- Study completion
- Jul 2012 (actual)
- First posted
- 4 Sep 2013 (estimated)
- 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 randomized controlled clinical pilot trial compared the efficacy of two soft tissue grafting methods for correcting esthetic discrepancies associated with non-molar implants in the maxilla. Specifically, it was explored whether defects treated with connective tissue grafts (SCTG) differed in their outcomes from defects treated with acellular dermal matrix allografts (ADM).
Detailed description
Thirteen patients who presented with implants displaying recession, thin biotype, concavity defects or a combination thereof associated with single crowned dental implants participated in this randomized control trial. The control group (N=7) received SCTG and the test group (N=6) received ADM, both under coronally positioned flaps. Data were collected before surgery, and 6 weeks, 3 months, and 6 months after the surgery. Outcome measures included soft tissue, hard tissue, and esthetics parameters and psychosocial data.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Connective Tissue Graft - Control | Active comparator | Procedure: Soft Tissue GraftingThe donor tissue was harvested from tissue palatal to maxillary premolars and anterior to the mesial of the first molars. A horizontal incision corresponding to the width of the recipient bed plus 4mm was made 3 mm apical to the gingival margin. A small secondary vertical incision was tolerated on the mesial aspect of the surgical site to allow for a split thickness technique. The flap was then positioned over the graft and sutured with attempts to cover the grafted tissue to 2mm coronal to the implant/abutment interface pending flap tension. Follow up was monitored over 6 months at various time-points. |
| Alloderm - Test | Experimental | Procedure: Soft Tissue GraftingADM graft was prepared according to the manufacturer's instructions. The preparation requires rehydration in 50ml sterile saline or Ringers Solution for five minutes and repeated twice. The graft was then transferred to the recipient bed with the basement membrane side facing up and connective tissue on the periosteum. The allograft was trimmed to cover the defect dimensions up to the implant-abutment interface. There was a 4mm margin added to the width on each side to account for lateral contraction as with the connective tissue. With sterile moist gauze, pressure was applied to the graft for proper adaptation to the wound bed. The graft was sutured with a single sling and the flap with a double sling. Simple interrupted sutures were used to close vertical releases. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Healthy adults of at least 18 years of age
- Maxillary non-molar implant with failing pink esthetic profile
- Implants with adjacent landmarks (only one can be an implant)
- Healthy implants measured by the lack of peri-implantitis and mucositis
- Good oral hygiene.
Key exclusion criteria (6 listed)
- Unstable systemic diseases, compromised immune system, or unstable bleeding disorders
- History of radiation or cancer in the oral cavity
- Use of IV bisphosphonate or steroid medication
- Use of tobacco products (>1/2 pack per day)
- Pregnancy
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 |
|---|---|---|
| Soft Tissue GraftingAll patients were treated with infiltration of local anesthetic with vasoconstrictor if noted tolerable by the medical history. Surgeons were then notified if the patient was randomized to the test or control according to a blinded treatment assignment. In both groups, anesthesia was confirmed at the implant site and the palatal donor site if indicated. The recipient bed was then prepared. Vertical incisions were made at the defect at line angles and horizontal incisions connected the two vertical releases intrasulcularly without involving the interdental papilla. The flap was reflected as a full thickness flap maintaining the integrity of the collagen attachment with de-epithelialization of papilla to allow for coronal advancement. | Procedure or surgery | Alloderm - Test, Connective Tissue Graft - Control |
Primary outcome
Recession Correction
Time frame: 6 Months
Change in recession was recorded at baseline, 6 weeks, 3 months and 6 months after grafting.
1 secondary outcome
Concavity Correction
Time frame: 6 Months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Feb 2017.
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, MS, PhD study chair
University of Michigan
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Soft Tissue Grafting in people with Dental Implant Soft Tissue Defects in the Anterior Maxilla, 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 5 inclusion and 6 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 10 Feb 2017. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Recession Correction (time frame: 6 Months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 10 Feb 2017.