Soft Tissue AtrophyPhase 4NCT04766255
Behavioral Comparison of Three Different Graft Materials to Increase Soft Tissue Thickness Around Dental Implants.
A Phase 4 study testing Soft Tissue graft augmentation and Implant Placement in people with Soft Tissue Atrophy and Mucogingival Deformity on Edentulous Ridge, run by Universitat Internacional de Catalunya at 1 site in Spain.
Trial summary
The purpose of the study is to compare soft tissue volume changes in terms of volume gain and stability around dental implants and PROMS in cases where a sub-epithelial connective tissue graft (SCTG) from the palate, Porcine collagen matrix (CM) or Porcine Acellular dermal matrix (PADM) is used after 3 and 15 months… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Soft Tissue Atrophy, Mucogingival Deformity on Edentulous Ridge, Edentulous Alveolar Ridge
- What is being tested?
- Soft Tissue graft augmentation and Implant Placement
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteSpain
- Study dates
- 1 May 2021to 30 Dec 2026
- Phase
- Phase 4
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patients referred to Department of Periodontology (CUO) in need of a single implant and need of soft tissue augmentation such as buccal defects, thin biotype, lack of keratinized tissue and aesthetic compromised situation.
- The patient must be ≥18 years and able to understand the nature of the proposed surgery and must sign an informed consent.
- The implant must be located between 2 fixed reference points (i.e. clinical crowns).
- Anterior and premolar teeth (from premolar to premolar).
- Enough crestal bone width to leave a minimum thickness of 2mm at the buccal bone plate when placing the implant.
- Palate must have ≥2mm of thickness at premolar area.
- Full mouth plaque and bleeding score <20%.
Who cannot join
- Pregnant or lactation.
- Active periodontal disease.
- Previous soft tissue augmentation in the area.
- Need of guided bone regeneration (GBR) during or after the placement of the implant.
- Heavy smokers (> 10 cigarettes per day).
- Local or systemic conditions that would interfere with routine periodontal therapy (non-controlled diabetes mellitus, cancer, HIV, Chronic High dose steroid therapy, bone metabolic diseases, radiation, immunosuppressive disorders, liver function disorder, immunosuppressant disease, autoimmune disease).
- Allergy to non-steroidal anti-inflammatory drugs.
- Patients taking medications that cause gingival enlargement.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Spain1 site, 1 recruiting
- Recruiting
Universitat Internacional de Catalunya
Sant Cugat del Vallès, Barcelona, 08195
Andres M Pascual La Rocca, Dentist, pascuallarocca@hotmail.com
Cristina V Valles Vega, Dentist, cvalles@hotmail.com
About this study
Official title: Behavioral Comparison of Three Different Graft Materials to Increase Soft Tissue Thickness Around Dental Implants in Terms of Volume Gain and Stability Over Time: A Randomized Clinical Trial.
The purpose of the study is to compare soft tissue volume changes in terms of volume gain and stability around dental implants and PROMS in cases where a sub-epithelial connective tissue graft (SCTG) from the palate, Porcine collagen matrix (CM) or Porcine Acellular dermal matrix (PADM) is used after 3 and 15 months after implant placement.
- Conditions
- Soft Tissue Atrophy, Mucogingival Deformity on Edentulous Ridge, Edentulous Alveolar Ridge
- Being tested
- Soft Tissue graft augmentation, Implant Placement
- Keywords
- soft tissue graft, acellular dermal graft, collagen matrix
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Soft Tissue graft augmentationProcedure or surgery
Donor site:
SCTG group: The SCTG will be harvested in the palat,In order to extract the same thickness in each grafts a double-bladed knife (separated by 1,5mm) will be used. The donor area will be sutured.
Recipient site:
SCTG group: the connective tissue graft will be trimmed to the correct dimensions (10mm height, 12mm length and 1,5mm thick) and placed and secured at the recipient site with a resorbable 5-0 suture CM group: The CM graft (Geistlich Fibro-gide) will be trimmed to the indicated dimensions (10mm height, 12mm length) and placed and secured at the recipient site with resorbable 5-0 suture PADM Group: the ADM (NovoMatrix, Biohorizons, Birmingham AL) graft will be trimmed to the indicated dimensions (10mm height, 12mm length) and placed and secured at the recipient site with resorbable 5-0 suture
Implant PlacementProcedure or surgery
A crestal incision will be made in the implant reception area, extending from the distal of the most mesial tooth to the mesial of the most distal tooth. A mucoperiosteal flap will be elevated in the most crestal part of the ridge. The receptor bed will be prepared following the established drilling protocol for the placement of a BioHorizons Tapered Pro Implant (Biohorizons, Birmingham AL). The diameter and length of the implant will be previously established during the implant study. Later a healing abutment will be placed.
| Study group | Role | What they receive |
|---|---|---|
| Control Group | Active comparator | Implant placement and prosthetic rehabilitation of the missing tooth Receives: Procedure: Implant Placement |
| SCTG group | Experimental | Implant placement, soft tissue augumentation of Connective Tissue Graft (from the palate) (SCTG) at the implant site and prosthetic rehabilitation of the missing tooth. Receives: Procedure: Soft Tissue graft augmentation; Procedure: Implant Placement |
| CM group | Experimental | Implant placement, soft tissue augumentation of porcine collagen matrix (CM) at the implant site and prosthetic rehabilitation of the missing tooth. Receives: Procedure: Soft Tissue graft augmentation; Procedure: Implant Placement |
| PADM group | Experimental | Implant placement, soft tissue augumentation of Porcine acellular dermal matrix (PADM) at the implant site and prosthetic rehabilitation of the missing tooth. Receives: Procedure: Soft Tissue graft augmentation; Procedure: Implant Placement |
What is being measured
The primary outcome is the main question the study is designed to answer.
soft tissue volume gain
Optical scans superposition
Measured: after 3 months
Secondary outcomes (8)
soft tissue volume stability
Optical scans superposition
Measured: after 15 months
Plaque index (PI)
Each tooth will be divided in 4 surfaces: buccal, lingual, mesial, distal. After the application of erythrosine, O'Leary plaque index will be registered (O'Leary et al. 1972)
Measured: at baseline, after 12 weeks and after 15 months.
Bleeding on probing (BI)
Each tooth will be divided in 4 surfaces: buccal, lingual, mesial, distal. After a gentle probing if the gingiva bleeds will be positive.
Measured: at baseline, after 12 weeks and after 15 months.
Probing depth (PD)
in the implant area (implant and both tooth next to it). Distance from the gingival margin to the bottom of the gingival sulcus using periodontal probe (UNC 15). Measured in 6 points: mesiobuccal, buccal, distobuccal, mesiolingual, lingual and distolingual.
Measured: at baseline, after 12 weeks and after 15 months.
Width of keratinized tissue (KT)
in the implant area (implant and both teeth nxt to it). Measured in the medial buccal point of the tooth/implant. Distance from mucogingival junction to the most apical portion of the crest of the marginal gingiva. The mucogingival junction will be identified by the roll technique, wherein the mucosa is rolled until the non-movable portion of the attached keratinized tissue is seen
Measured: at baseline, after 12 weeks and after 15 months.
Phenotype evaluation (PT)
the gingival biotype was categorized as thin or thick based on the transparency of a periodontal probe (CP15 UNC; Hu-Friedy, Chicago, IL, USA) through the soft tissues while probing the buccal sulcus of the contra-lateral tooth (17-19)
Measured: at baseline, after 12 weeks and after 15 months.
Patient reported outcome measures (PROMs)
patient pain/discomfort will be evaluated (a questionnaire will be provided to each patient after all the surgery procedures and it will be recollected the day of suture removal)
Measured: after the surgery procedures (baseline) and after 7 days (suture removal)
Pink Esthetic Score (PES)
will be registered to obtain information related to the papilla, the level of soft-tissue margin, the alveolar process, the color, contour and texture of the same soft tissue
Measured: After 2 weeks of the definite crown placement (around 16 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Feb 2021
- Study start1 May 2021
- Primary completion30 Dec 2025 (estimated)
- Study completion30 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Soft Tissue AtrophyStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- controlled randomized prospective clinical study.
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universitat Internacional de Catalunya
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Andres Pascual La Rocca, Universitat Internacional de Catalunya
- Investigators
- Andres Pascual La Rocca, DDS, Principal investigator, Universitat Internacional de Catalunya
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04766255
- Sponsor's protocol ID
- PER-ECL-2017-07
- Status last verified
- Dec 2024
- First submitted
- 17 Feb 2021
- Last updated
- 11 Dec 2024
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Behavioral Comparison of Three Different Graft Materials to Increase Soft Tissue Thickness Around Dental Implants in Terms of Volume Gain and Stability Over Time: A Randomized Clinical Trial.
- ClinicalTrials.gov ID
- NCT04766255
- Acronym / sponsor ID
- PER-ECL-2017-07
- Conditions
- Soft Tissue Atrophy, Mucogingival Deformity on Edentulous Ridge, Edentulous Alveolar Ridge
- Keywords
- soft tissue graft, acellular dermal graft, collagen matrix
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Universitat Internacional de CatalunyaUniversity, hospital or other
- Study start
- 1 May 2021 (actual)
- Primary completion
- 30 Dec 2025 (estimated)
- Study completion
- 30 Dec 2026 (estimated)
- First posted
- 23 Feb 2021 (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 purpose of the study is to compare soft tissue volume changes in terms of volume gain and stability around dental implants and PROMS in cases where a sub-epithelial connective tissue graft (SCTG) from the palate, Porcine collagen matrix (CM) or Porcine Acellular dermal matrix (PADM) is used after 3 and 15 months after implant placement.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 4
- Model description
- controlled randomized prospective clinical study.
| Arm | Type | Receives |
|---|---|---|
| Control Group | Active comparator | Procedure: Implant PlacementImplant placement and prosthetic rehabilitation of the missing tooth |
| SCTG group | Experimental | Procedure: Soft Tissue graft augmentation, Procedure: Implant PlacementImplant placement, soft tissue augumentation of Connective Tissue Graft (from the palate) (SCTG) at the implant site and prosthetic rehabilitation of the missing tooth. |
| CM group | Experimental | Procedure: Soft Tissue graft augmentation, Procedure: Implant PlacementImplant placement, soft tissue augumentation of porcine collagen matrix (CM) at the implant site and prosthetic rehabilitation of the missing tooth. |
| PADM group | Experimental | Procedure: Soft Tissue graft augmentation, Procedure: Implant PlacementImplant placement, soft tissue augumentation of Porcine acellular dermal matrix (PADM) at the implant site and prosthetic rehabilitation of the missing tooth. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Patients referred to Department of Periodontology (CUO) in need of a single implant and need of soft tissue augmentation such as buccal defects, thin biotype, lack of keratinized tissue and aesthetic compromised situation.
- The patient must be ≥18 years and able to understand the nature of the proposed surgery and must sign an informed consent.
- The implant must be located between 2 fixed reference points (i.e. clinical crowns).
- Anterior and premolar teeth (from premolar to premolar).
- Enough crestal bone width to leave a minimum thickness of 2mm at the buccal bone plate when placing the implant.
Key exclusion criteria (8 listed)
- Pregnant or lactation.
- Active periodontal disease.
- Previous soft tissue augmentation in the area.
- Need of guided bone regeneration (GBR) during or after the placement of the implant.
- Heavy smokers (> 10 cigarettes per day).
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 graft augmentationDonor site: SCTG group: The SCTG will be harvested in the palat,In order to extract the same thickness in each grafts a double-bladed knife (separated by 1,5mm) will be used. The donor area will be sutured. Recipient site: SCTG group: the connective tissue graft will be trimmed to the correct dimensions (10mm height, 12mm length and 1,5mm thick) and placed and secured at the recipient site with a resorbable 5-0 suture CM group: The CM graft (Geistlich Fibro-gide) will be trimmed to the indicated dimensions (10mm height, 12mm length) and placed and secured at the recipient site with resorbable 5-0 suture PADM Group: the ADM (NovoMatrix, Biohorizons, Birmingham AL) graft will be trimmed to the indicated dimensions (10mm height, 12mm length) and placed and secured at the recipient site with resorbable 5-0 suture | Procedure or surgery | CM group, PADM group, SCTG group |
| Implant PlacementA crestal incision will be made in the implant reception area, extending from the distal of the most mesial tooth to the mesial of the most distal tooth. A mucoperiosteal flap will be elevated in the most crestal part of the ridge. The receptor bed will be prepared following the established drilling protocol for the placement of a BioHorizons Tapered Pro Implant (Biohorizons, Birmingham AL). The diameter and length of the implant will be previously established during the implant study. Later a healing abutment will be placed. | Procedure or surgery | CM group, Control Group, PADM group, SCTG group |
Primary outcome
soft tissue volume gain
Time frame: after 3 months
Optical scans superposition
8 secondary outcomes
soft tissue volume stability
Time frame: after 15 months
Plaque index (PI)
Time frame: at baseline, after 12 weeks and after 15 months.
Bleeding on probing (BI)
Time frame: at baseline, after 12 weeks and after 15 months.
Probing depth (PD)
Time frame: at baseline, after 12 weeks and after 15 months.
Width of keratinized tissue (KT)
Time frame: at baseline, after 12 weeks and after 15 months.
Phenotype evaluation (PT)
Time frame: at baseline, after 12 weeks and after 15 months.
Patient reported outcome measures (PROMs)
Time frame: after the surgery procedures (baseline) and after 7 days (suture removal)
Pink Esthetic Score (PES)
Time frame: After 2 weeks of the definite crown placement (around 16 months)
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 11 Dec 2024.
- 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.
Andres Pascual La Rocca, DDS principal investigator
Universitat Internacional de Catalunya
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Soft Tissue graft augmentation and Implant Placement in people with Soft Tissue Atrophy and Mucogingival Deformity on Edentulous Ridge, run by Universitat Internacional de Catalunya at 1 site in Spain.
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 8 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: looking for participants now, as of the sponsor's last update on 11 Dec 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 Spain. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 Andres Pascual La Rocca, DDS (0034627725044, pascuallarocca@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
soft tissue volume gain (time frame: after 3 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 11 Dec 2024.