Tooth LossNCT03090906
Soft Tissue Volume Gain and Stability Comparing Palate and Tuberosity
A study testing Soft tissue augmentation palate, Soft tissue augmentation tuberosity and Intraoral optical scan in people with Tooth Loss and Recession, Gingival, run by Universitat Internacional de Catalunya.
Trial summary
The goal of this study is to compare clinical and histologically the soft tissue changes in terms of volume gain and stability around dental implants in cases where a subepithelial connective tissue graft from the palate or from the tuberosity is used randomly Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Tooth Loss, Recession, Gingival
- What is being tested?
- Soft tissue augmentation palate, Soft tissue augmentation tuberosity and Intraoral optical scan
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- No sites listed yet
- Study dates
- Apr 2015to Aug 2017
- 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
- Patient must be ≥18 years and able to understand the nature of the proposed surgery and to a signed informed consent.
- Implant must be located between 2 fixed reference points i.e. clinical crowns.
- All implants locations with a need of a soft tissue volume augmentation.
- Palate must have ≥2mm of thickness at premolar area.
- Tuberosity > 12mm in length.
- Full mouth plaque and bleeding score <20%.
Who cannot join
- Previous soft tissue augmentation in the area.
- Heavy Smokers (> 10 cigarettes per day).
- Local or systemic conditions that would interfere with routine periodontal therapy (non controlled diabetes, liver function disorder, immunosuppressant disease, autoimmune disease).
- Allergy to Non-Steroidal Anti-Inflammatory Drugs.
- Patients taking medications that cause gingival enlargement
- Gingival idiopatic overgrowth
About this study
Official title: Clinical and Histological Analysis of Soft Tissue Volume Gain and Stability Around Dental Implants Using Autogenous Subepithelial Connective Tissue Grafts Harvested From the Palate or Tuberosity. A Randomized Controlled Clinical Study
The goal of this study is to compare clinical and histologically the soft tissue changes in terms of volume gain and stability around dental implants in cases where a subepithelial connective tissue graft from the palate or from the tuberosity is used randomly
Read the detailed description
Understanding the importance of the soft tissue around implants have lead clinicians to develop surgical approaches to augment it. The majority of them, are described as bilaminar techniques obtaining a subephitelial connective tissue graft (SCTG) from the palate (P). However, recent studies have demonstrated that tuberosity (T) tissue is a very dense and coarse tissue that seems to contain more collagen and less fat and glandular tissue than that from the P, and therefore may have better tissue qualities for soft tissue augmentation, but there is limited scientific evidence comparing these areas.
The main goal of this study is to compare the soft tissue volume gain and stability around implants in cases where a SCTG of the same dimensions from the P or T is used randomly. To calculate volume changes and stability an intraoral optical scan is used and three-dimensional images superimposed.
The secondary goal is to compare histologically both tissues and changes in clinical parameters. Histomorphometry and immunohistochemistry evaluating levels of Type I-III collagen, long lysyl hydroxylase, matrix metalloproteinase 1-2, and monoclonal antibody against cytokeratin 4-10-13 is performed.
- Conditions
- Tooth Loss, Recession, Gingival
- Being tested
- Soft tissue augmentation palate, Soft tissue augmentation tuberosity, Intraoral optical scan
- Keywords
- volume gain, soft tissue augmentation, dental implants, histology
- Medical subject headings
- Tooth Loss, Gingival Recession
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Soft tissue augmentation palateProcedure or surgery
Also called subepithelial connective tissue graft
Recipient site: Intrasulcular incision at the buccal side of the implant extending in one adjacent tooth for each side and a partial-thickness mucosal flap raised. The connective tissue was secured with suture. Allocation to either treatment was performed according to a randomization table.
Donor site A double-bladed scalpel handle 1,5mm was used in both areas to obtain the same thickness.
Palate (CG) The double incision was made approximately 2 to 3 mm apical to the gingival margins of premolars. The donor tissue was removed and cross-mattress sutures were used to approximate the wound on the palate.
In both groups the epithelial collar removed. Graft required dimensions for both groups:10mm height, 12mm length and 1,5mm thick.
Soft tissue augmentation tuberosityProcedure or surgery
Also called subepithelial connective tissue graft
Recipient site: Intrasulcular incision at the buccal side of the implant extending in one adjacent tooth for each side and a partial-thickness mucosal flap raised. The connective tissue was secured with suture. Allocation to either treatment was performed according to a randomization table.
Donor site A double-bladed scalpel handle 1,5mm was used in both areas to obtain the same thickness.
Tuberosity (TG) The double incision was made from the distal of the terminal tooth. A second incision was made perpendicular to the linear incision at a distal point, which joined the two linear incisions. The graft was removed and a crossed horizontal suspension suture was used.
Epithelial collar removed. Graft required dimensions for both groups:10mm height, 12mm length and 1,5mm thick.
Intraoral optical scanDevice
Intraoral optical scan was performed at both groups at baseline, 3 months, 4 months and 12 months to be able to compare volumetric changes.
| Study group | Role | What they receive |
|---|---|---|
| Control group: SCTG from palate | Experimental | Soft tissue augmentation palate Receives: Procedure: Soft tissue augmentation palate; Device: Intraoral optical scan |
| Test group: SCTG from tuberosity | Experimental | Soft tissue augmentation tuberosity Receives: Procedure: Soft tissue augmentation tuberosity; Device: Intraoral optical scan |
What is being measured
The primary outcome is the main question the study is designed to answer.
Soft tissue volume gain
Following soft tissue augmentation procedure volume gain is registered using intraoral optical scan. Superposition between three dimensional images from baseline (before augmentation procedure) and 3 months postoperative is done.
Measured: Baseline to 3 months postoperative
Soft tissue stability
To evaluate soft tissue stability an intraoral optical scan is performed at 4 and 12 months postoperative. Also a superimposition between 4 months and 12 months optical images is done.
Measured: 4 months postoperative to 12 months postoperative
Secondary outcomes (4)
Histology
Descriptive histology and immunohistochemistry evaluating: Type I-III collagen, long lysyl hydroxylase, matrix metalloproteinase 1-2, and monoclonal antibody against cytokeratin 4-10-13.
Measured: Baseline
Clinical periodontal parameters Plaque Index and Bleeding on probing
Plaque index, bleeding on probing expressed as a full mouth %.
Measured: Baseline, 3 months, 4 months, 12 months
Clinical periodontal parameters.Probing depth
Probing depth expressed in mm. Evaluated at implant and adjacent teeth. At Mesial, distal, buccal, lingual, mesiobuccal, mesiolingual, distobuccal and distolingual levels.
Measured: Baseline, 3 months, 4 months, 12 months
Clinical periodontal parameters. Width of keratinized tissue
Width of keratinized tissue expressed in mm, evaluated at medial point at implant and adjacent teeth one.
Measured: Baseline, 3 months, 4 months, 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Mar 2017
- Study startApr 2015
- Primary completionMar 2017
- Study completionAug 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Tooth LossStudies of the same condition, open and under way.
- 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
- Investigator, Outcomes assessor
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universitat Internacional de Catalunya
- Sponsor type
- University, hospital or other
- Collaborators
- Osteology Foundation
- Responsible party
- Principal investigator, Ernest Rojo Xicart, Universitat Internacional de Catalunya
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03090906
- Sponsor's protocol ID
- PER- ECL-2011-10-NF
- Status last verified
- May 2017
- First submitted
- 29 Jan 2017
- Last updated
- 4 May 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical and Histological Analysis of Soft Tissue Volume Gain and Stability Around Dental Implants Using Autogenous Subepithelial Connective Tissue Grafts Harvested From the Palate or Tuberosity. A Randomized Controlled Clinical Study
- ClinicalTrials.gov ID
- NCT03090906
- Acronym / sponsor ID
- PER- ECL-2011-10-NF
- Conditions
- Tooth Loss, Recession, Gingival
- Keywords
- volume gain, soft tissue augmentation, dental implants, histology
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Universitat Internacional de CatalunyaUniversity, hospital or other
- Collaborators
- Osteology Foundation
- Study start
- Apr 2015
- Primary completion
- Mar 2017 (actual)
- Study completion
- Aug 2017 (estimated)
- First posted
- 27 Mar 2017 (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.
The goal of this study is to compare clinical and histologically the soft tissue changes in terms of volume gain and stability around dental implants in cases where a subepithelial connective tissue graft from the palate or from the tuberosity is used randomly
Detailed description
Understanding the importance of the soft tissue around implants have lead clinicians to develop surgical approaches to augment it. The majority of them, are described as bilaminar techniques obtaining a subephitelial connective tissue graft (SCTG) from the palate (P). However, recent studies have demonstrated that tuberosity (T) tissue is a very dense and coarse tissue that seems to contain more collagen and less fat and glandular tissue than that from the P, and therefore may have better tissue qualities for soft tissue augmentation, but there is limited scientific evidence comparing these areas.
The main goal of this study is to compare the soft tissue volume gain and stability around implants in cases where a SCTG of the same dimensions from the P or T is used randomly. To calculate volume changes and stability an intraoral optical scan is used and three-dimensional images superimposed.
The secondary goal is to compare histologically both tissues and changes in clinical parameters. Histomorphometry and immunohistochemistry evaluating levels of Type I-III collagen, long lysyl hydroxylase, matrix metalloproteinase 1-2, and monoclonal antibody against cytokeratin 4-10-13 is performed.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control group: SCTG from palate | Experimental | Procedure: Soft tissue augmentation palate, Device: Intraoral optical scanSoft tissue augmentation palate |
| Test group: SCTG from tuberosity | Experimental | Procedure: Soft tissue augmentation tuberosity, Device: Intraoral optical scanSoft tissue augmentation tuberosity |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Patient must be ≥18 years and able to understand the nature of the proposed surgery and to a signed informed consent.
- Implant must be located between 2 fixed reference points i.e. clinical crowns.
- All implants locations with a need of a soft tissue volume augmentation.
- Palate must have ≥2mm of thickness at premolar area.
- Tuberosity > 12mm in length.
Key exclusion criteria (6 listed)
- Previous soft tissue augmentation in the area.
- Heavy Smokers (> 10 cigarettes per day).
- Local or systemic conditions that would interfere with routine periodontal therapy (non controlled diabetes, liver function disorder, immunosuppressant disease, autoimmune disease).
- Allergy to Non-Steroidal Anti-Inflammatory Drugs.
- Patients taking medications that cause gingival enlargement
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 augmentation palateAlso: subepithelial connective tissue graftRecipient site: Intrasulcular incision at the buccal side of the implant extending in one adjacent tooth for each side and a partial-thickness mucosal flap raised. The connective tissue was secured with suture. Allocation to either treatment was performed according to a randomization table. Donor site A double-bladed scalpel handle 1,5mm was used in both areas to obtain the same thickness. Palate (CG) The double incision was made approximately 2 to 3 mm apical to the gingival margins of premolars. The donor tissue was removed and cross-mattress sutures were used to approximate the wound on the palate. In both groups the epithelial collar removed. Graft required dimensions for both groups:10mm height, 12mm length and 1,5mm thick. | Procedure or surgery | Control group: SCTG from palate |
| Soft tissue augmentation tuberosityAlso: subepithelial connective tissue graftRecipient site: Intrasulcular incision at the buccal side of the implant extending in one adjacent tooth for each side and a partial-thickness mucosal flap raised. The connective tissue was secured with suture. Allocation to either treatment was performed according to a randomization table. Donor site A double-bladed scalpel handle 1,5mm was used in both areas to obtain the same thickness. Tuberosity (TG) The double incision was made from the distal of the terminal tooth. A second incision was made perpendicular to the linear incision at a distal point, which joined the two linear incisions. The graft was removed and a crossed horizontal suspension suture was used. Epithelial collar removed. Graft required dimensions for both groups:10mm height, 12mm length and 1,5mm thick. | Procedure or surgery | Test group: SCTG from tuberosity |
| Intraoral optical scanIntraoral optical scan was performed at both groups at baseline, 3 months, 4 months and 12 months to be able to compare volumetric changes. | Device | Control group: SCTG from palate, Test group: SCTG from tuberosity |
Primary outcome
Soft tissue volume gain
Time frame: Baseline to 3 months postoperative
Following soft tissue augmentation procedure volume gain is registered using intraoral optical scan. Superposition between three dimensional images from baseline (before augmentation procedure) and 3 months postoperative is done.
Soft tissue stability
Time frame: 4 months postoperative to 12 months postoperative
To evaluate soft tissue stability an intraoral optical scan is performed at 4 and 12 months postoperative. Also a superimposition between 4 months and 12 months optical images is done.
4 secondary outcomes
Histology
Time frame: Baseline
Clinical periodontal parameters Plaque Index and Bleeding on probing
Time frame: Baseline, 3 months, 4 months, 12 months
Clinical periodontal parameters.Probing depth
Time frame: Baseline, 3 months, 4 months, 12 months
Clinical periodontal parameters. Width of keratinized tissue
Time frame: Baseline, 3 months, 4 months, 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 May 2017.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Soft tissue augmentation palate, Soft tissue augmentation tuberosity and Intraoral optical scan in people with Tooth Loss and Recession, Gingival, run by Universitat Internacional de Catalunya.
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 6 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: status not confirmed, as of the sponsor's last update on 4 May 2017. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
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?
Soft tissue volume gain (time frame: Baseline to 3 months postoperative). 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?
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 4 May 2017.