Bone Graft; Complications, Infection or InflammationNCT03774888
To Compare Different Soft Tissue Grafts at the Time of Lateral Ridge Augmentation Procedure.
A study testing Connective tissue graft at time of bone graft, Acellular Demal Matrix at time of bone graft and No soft tissue grafting at time of bone graft in people with Bone Graft; Complications, Infection or Inflammation and Ridge Deficency, run by University of Alabama at Birmingham at 1 site in United States.
Trial summary
This study will compare two commonly used soft tissue grafting techniques (connective tissue graft, CTG vs Acellular Dermal Matrix, ADM) to augment the soft tissue at the time of lateral ridge augmentation procedure. Read more about this study
- Who is it for?
- Ages 18 to 99 yearsHealthy volunteers can take part
- Conditions the study is for
- Bone Graft; Complications, Infection or Inflammation, Ridge Deficency, Dental Implant
- What is being tested?
- Connective tissue graft at time of bone graft, Acellular Demal Matrix at time of bone graft and No soft tissue grafting at time of bone graft
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteUnited States
- Study dates
- 3 Oct 2019to 5 Jul 2023
- 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 to 99 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Be a registered University of Alabama at Birmingham (UAB) dental school patient
- English Speaking
- Healthy enough to undergo the proposed therapy
- Demonstrated willingness to comply with study directions and time-line
- Insufficient alveolar ridge width for endosseous implant placement defined as 5mm or less as determined by bone sounding and cone beam computed tomography (CBCT) scan.
- Able to read and understand the informed consent form
- Need for implants to replace missing tooth or teeth in at least one quadrant of the mouth.
Who cannot join
- No English Speaking
- Smokers/ tobacco users (>10 cigarettes a day)
- Less than 18 years old
- Know hypersensitivity to titanium
- Patients with significant medical conditions or habbits expected to interfere with bony healing.
- Patient is a poor compliance risk (i.e., poor oral hygiene, history of alcohol or drug abuse)
- Bone dehiscence of >4mm following tooth extraction or Vertical loss of bone at edentulous ridge
Trial locations and contacts
1 site in 1 country.
United States1 site
Unversity of Alabama at Birmingham, School of Dentistry
Birmingham, Alabama, 35294-0007
About this study
Official title: A Randomized Controlled Trial to Compare the Histomorphometric and Clinical Outcomes of Soft Tissue Augmentation at the Time of Lateral Ridge Augmentation Procedures
This study will compare two commonly used soft tissue grafting techniques (connective tissue graft, CTG vs Acellular Dermal Matrix, ADM) to augment the soft tissue at the time of lateral ridge augmentation procedure.
Following ridge augmentation procedure, most of the times there is a need for soft tissue augmentation to change the quality of the tissue around future implant's site. To our knowledge, the influence of soft tissue augmentation at the time of ridge augmentation procedure has not been tested defects.
Read the detailed description
Research data and daily clinical observations reveal that implants with lack of surrounding keratinized mucosa KM (gingiva-like tissue that normally surrounds natural teeth) are more prone to persistent gingival inflammation, faster disease progression and compromised plaque control. Ridge augmentation procedure can alter the quality of tissue in the sites where it will receive dental implants. Soft tissue grating aims at changing the nature of peri-implant soft tissue by creating or increasing the zone of keratinized mucosa (KM) surrounding implants. CTG or ADM will be grafted at the same time of lateral ridge augmentation procedure.
Specific aims for this project include the evaluation of:
- To evaluate the quality of soft tissue regenerated with the use of the two available soft tissue grafts via histological analysis.
- To evaluate whether CTG or ADM influences the outcomes of Guided Bone Regeneration (GBR) procedures.
- To quantify the soft tissue augmentation achieved by the two available soft tissue grafts by direct clinical measurements after the healing
- Being tested
- Connective tissue graft at time of bone graft, Acellular Demal Matrix at time of bone graft, No soft tissue grafting at time of bone graft
- Keywords
- Keratinized Tissue, Keratinized mucosa, attached mucosa, dental implants, ridge augmentation, guided bone regeneration, connective tissue graft, acellular demral matrix
- Medical subject headings
- Infections, Inflammation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Connective tissue graft at time of bone graftProcedure or surgery
following the placement of the bone graft and the membrane, a CTG will be harvested and sutured to the membrane and then the flaps passively sutured on top on the bone and soft tissue graft
Acellular Demal Matrix at time of bone graftProcedure or surgery
following the placement of the bone graft and the membrane, an ADM will be sutured to the membrane and then the flaps passively sutured on top on the bone and soft tissue graft
No soft tissue grafting at time of bone graftProcedure or surgery
Following the placement of the bone graft and the membrane, the flaps passively sutured on top on the bone. No soft tissue graft will be added.
| Study group | Role | What they receive |
|---|---|---|
| connective tissue graft | Experimental | Connective tissue grafting (CTG) will be placed at the time of lateral ridge augmentation.Following the placement of the bone graft and the membrane, a CTG will be harvested and sutured to the membrane and then the flaps passively sutured on top on the bone and soft tissue graft Receives: Procedure: Connective tissue graft at time of bone graft |
| Acellular Dermal Matrix | Experimental | Acellular Dermal matrix (ADM) will be placed at the time of lateral ridge augmentation.Following the placement of the bone graft and the membrane, an ADM will be sutured to the membrane and then the flaps passively sutured on top on the bone and soft tissue graft Receives: Procedure: Acellular Demal Matrix at time of bone graft |
| No soft tissue graft (Control) | Active comparator | Control group where no soft tissue graft is added to the lateral ridge augmentation.Following the placement of the bone graft and the membrane, the flaps passively sutured on top on the bone. No soft tissue graft will be added. Receives: Procedure: No soft tissue grafting at time of bone graft |
What is being measured
The primary outcome is the main question the study is designed to answer.
Measure Changes Clinically in Crestal Soft Tissue Thickness (in mm)
The changes in clinical vertical crestal soft tissue thickness by using an endodontic file and periodontal probe.
Measured: From baseline to 6 months
Measure Changes Digitally in Crestal Soft Tissue Thickness (in mm)
The changes in soft tissue thickness digitally with superimposition of the intraoral scan and cone-bone computed tomography scan.
Measured: From baseline to 6 months
Measure Changes Clinically in Soft Tissue Thickness at 4mm Apical From Gingival Margin
The changes in clinical soft tissue thickness at 4mm apical form the gingival margin by using an endodontic file and periodontal probe.
Measured: From baseline to 6 months
Measure Changes Digitally in Soft Tissue Thickness at 4mm Apical Form Gingival Margin
The changes in soft tissue thickness digitally with superimposition of the intraoral scan and cone-bone computed tomography scan.
Measured: From baseline to 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Dec 2018
- Study start3 Oct 2019
- Primary completion10 May 2021
- Study completion5 Jul 2023
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.
- Other trials for Bone Graft; Complications, Infection or InflammationStudies of the same condition, open and under way.
- More trials run by University of Alabama at BirminghamThe 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
- None (open label)
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Alabama at Birmingham
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hussein Basma, University of Alabama at Birmingham
- Investigators
- Hussein Basma, DDS, MS, Principal investigator, University of Alabama at Birmingham
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03774888
- Sponsor's protocol ID
- IRB-300002688
- Status last verified
- Nov 2023
- First submitted
- 11 Dec 2018
- Last updated
- 9 May 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Controlled Trial to Compare the Histomorphometric and Clinical Outcomes of Soft Tissue Augmentation at the Time of Lateral Ridge Augmentation Procedures
- ClinicalTrials.gov ID
- NCT03774888
- Acronym / sponsor ID
- IRB-300002688
- Keywords
- Keratinized Tissue, Keratinized mucosa, attached mucosa, dental implants, ridge augmentation, guided bone regeneration, connective tissue graft, acellular demral matrix
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- University of Alabama at BirminghamUniversity, hospital or other
- Study start
- 3 Oct 2019 (actual)
- Primary completion
- 10 May 2021 (actual)
- Study completion
- 5 Jul 2023 (actual)
- First posted
- 13 Dec 2018 (actual)
- Results
- Posted 9 May 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study will compare two commonly used soft tissue grafting techniques (connective tissue graft, CTG vs Acellular Dermal Matrix, ADM) to augment the soft tissue at the time of lateral ridge augmentation procedure.
Following ridge augmentation procedure, most of the times there is a need for soft tissue augmentation to change the quality of the tissue around future implant's site. To our knowledge, the influence of soft tissue augmentation at the time of ridge augmentation procedure has not been tested defects.
Detailed description
Research data and daily clinical observations reveal that implants with lack of surrounding keratinized mucosa KM (gingiva-like tissue that normally surrounds natural teeth) are more prone to persistent gingival inflammation, faster disease progression and compromised plaque control. Ridge augmentation procedure can alter the quality of tissue in the sites where it will receive dental implants. Soft tissue grating aims at changing the nature of peri-implant soft tissue by creating or increasing the zone of keratinized mucosa (KM) surrounding implants. CTG or ADM will be grafted at the same time of lateral ridge augmentation procedure.
Specific aims for this project include the evaluation of:
- To evaluate the quality of soft tissue regenerated with the use of the two available soft tissue grafts via histological analysis.
- To evaluate whether CTG or ADM influences the outcomes of Guided Bone Regeneration (GBR) procedures.
- To quantify the soft tissue augmentation achieved by the two available soft tissue grafts by direct clinical measurements after the healing
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| connective tissue graft | Experimental | Procedure: Connective tissue graft at time of bone graftConnective tissue grafting (CTG) will be placed at the time of lateral ridge augmentation.Following the placement of the bone graft and the membrane, a CTG will be harvested and sutured to the membrane and then the flaps passively sutured on top on the bone and soft tissue graft |
| Acellular Dermal Matrix | Experimental | Procedure: Acellular Demal Matrix at time of bone graftAcellular Dermal matrix (ADM) will be placed at the time of lateral ridge augmentation.Following the placement of the bone graft and the membrane, an ADM will be sutured to the membrane and then the flaps passively sutured on top on the bone and soft tissue graft |
| No soft tissue graft (Control) | Active comparator | Procedure: No soft tissue grafting at time of bone graftControl group where no soft tissue graft is added to the lateral ridge augmentation.Following the placement of the bone graft and the membrane, the flaps passively sutured on top on the bone. No soft tissue graft will be added. |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Be a registered University of Alabama at Birmingham (UAB) dental school patient
- English Speaking
- Healthy enough to undergo the proposed therapy
- Demonstrated willingness to comply with study directions and time-line
- Insufficient alveolar ridge width for endosseous implant placement defined as 5mm or less as determined by bone sounding and cone beam computed tomography (CBCT) scan.
Key exclusion criteria (7 listed)
- No English Speaking
- Smokers/ tobacco users (>10 cigarettes a day)
- Less than 18 years old
- Know hypersensitivity to titanium
- Patients with significant medical conditions or habbits expected to interfere with bony healing.
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 |
|---|---|---|
| Connective tissue graft at time of bone graftfollowing the placement of the bone graft and the membrane, a CTG will be harvested and sutured to the membrane and then the flaps passively sutured on top on the bone and soft tissue graft | Procedure or surgery | connective tissue graft |
| Acellular Demal Matrix at time of bone graftfollowing the placement of the bone graft and the membrane, an ADM will be sutured to the membrane and then the flaps passively sutured on top on the bone and soft tissue graft | Procedure or surgery | Acellular Dermal Matrix |
| No soft tissue grafting at time of bone graftFollowing the placement of the bone graft and the membrane, the flaps passively sutured on top on the bone. No soft tissue graft will be added. | Procedure or surgery | No soft tissue graft (Control) |
Primary outcome
Measure Changes Clinically in Crestal Soft Tissue Thickness (in mm)
Time frame: From baseline to 6 months
The changes in clinical vertical crestal soft tissue thickness by using an endodontic file and periodontal probe.
Measure Changes Digitally in Crestal Soft Tissue Thickness (in mm)
Time frame: From baseline to 6 months
The changes in soft tissue thickness digitally with superimposition of the intraoral scan and cone-bone computed tomography scan.
Measure Changes Clinically in Soft Tissue Thickness at 4mm Apical From Gingival Margin
Time frame: From baseline to 6 months
The changes in clinical soft tissue thickness at 4mm apical form the gingival margin by using an endodontic file and periodontal probe.
Measure Changes Digitally in Soft Tissue Thickness at 4mm Apical Form Gingival Margin
Time frame: From baseline to 6 months
The changes in soft tissue thickness digitally with superimposition of the intraoral scan and cone-bone computed tomography scan.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 May 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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.
Hussein Basma, DDS, MS principal investigator
University of Alabama at Birmingham
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Connective tissue graft at time of bone graft, Acellular Demal Matrix at time of bone graft and No soft tissue grafting at time of bone graft in people with Bone Graft; Complications, Infection or Inflammation and Ridge Deficency, run by University of Alabama at Birmingham 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 7 inclusion and 7 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 9 May 2024. 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 9 May 2024). 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?
Measure Changes Clinically in Crestal Soft Tissue Thickness (in mm) (time frame: From baseline to 6 months). The study lists 4 primary outcomes in all. 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 9 May 2024.