Dental CrowdingNCT07097714
Evaluating the Clinical Efficacy of Collagen Scaffold (Ossix VOLUMAX) With Piezo-Surgical Decortication in Enhancing Orthodontic Treatment Outcomes: A Randomized Controlled Trial
A study testing Piezocision with ribose cross-linked collagen matrix (Ossix® Volumax) in people with Dental Crowding and Gingival Recession, run by NMSI DENTMASTER at 1 site in Russia.
Trial summary
Recent advances in orthodontic treatment have explored various materials to enhance treatment efficacy, particularly focusing on collagen scaffolds. Collagen, being a primary component of the bone matrix, has garnered attention for its biocompatibility, cell adhesion, and osteoconductivity properties. Read more about this study
- Who is it for?
- Ages 18 to 50 years
- Conditions the study is for
- Dental Crowding, Gingival Recession, Thin Phenotype
- What is being tested?
- Piezocision with ribose cross-linked collagen matrix (Ossix® Volumax)
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteRussia
- Study dates
- 25 Jun 2024to 25 Sep 2026
- Phase
- Interventional
- 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 to 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
None listed.
Who cannot join
- Existing Periodontal Disease: Individuals with active periodontal disease or significant periodontal bone loss that contraindicates orthodontic treatment.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Russia1 site, 1 recruiting
- Recruiting
Dental Clinic "Dental-Service" - Department of Oral and Maxillofacial Surgery, 77 S. Vanzetti Street
Novosibirsk, Novosibirsk Oblast, 630000
Tatiana Andreevna Gatilova, DDS, +79529399919, TAGatilova@gmail.com
Tatiana Andreevna Gatilova, DDS, TAGatilova@gmail.com
About this study
Recent advances in orthodontic treatment have explored various materials to enhance treatment efficacy, particularly focusing on collagen scaffolds. Collagen, being a primary component of the bone matrix, has garnered attention for its biocompatibility, cell adhesion, and osteoconductivity properties. Studies have shown that collagen scaffolds undergo natural degradation, mimicking biological processes, and play a significant role in tissue engineering (International Journal of Implant Dentistry, 2023). This aligns with the growing interest in minimally invasive methods that accelerate orthodontic treatment and improve tissue regeneration.
In this context, the application of collagen scaffolds, such as Ossix VOLUMAX, in conjunction with piezo-surgical decortication, presents a novel approach. This study aims to build upon the existing knowledge, exploring the efficacy of collagen scaffolds in enhancing orthodontic treatment outcomes, especially in patients with specific dental conditions like a thin gingival phenotype and malocclusion. The study\'s hypothesis is grounded in the promising properties of collagen-based materials in dental and orthodontic applications, as evidenced by recent research in the field.
Read the detailed description
Hypothesis:
The application of a Collagen Scaffold (Ossix VOLUMAX) in conjunction with piezo- surgical decortication enhances the efficacy of orthodontic treatment by increasing the thickness of gingiva and volume of alveolar bone in adults with a thin phenotype of gingiva and malocclusion, particularly in the mandibular incisors, more effectively than piezo- surgical decortication with a connective tissue graft alone. This combined treatment also reduces morbidity, decreases the risk of gingival recessions, and shortens the duration of surgery compared to the control group.
Study Groups:
In this clinical trial, the participants are divided into two groups to compare the outcomes of different surgical interventions in conjunction with orthodontic treatment:
Intervention Group:
This group will receive the novel treatment combination. Participants in this arm will undergo piezocisions, a minimally invasive surgical technique that aids in orthodontic tooth movement by creating vertical corticotomy grooves in the alveolar bone to facilitate its remodeling. Along with this procedure, a Collagen Scaffold (specifically, Ossix VOLUMAX) will be applied. The scaffold is likely designed to support the regeneration of bone and soft tissue, potentially enhancing the effects of the decortication and improving clinical outcomes such as bone volume and gingival thickness.
Control Group:
The control group will receive piezocisions will be performed in strategic locations to accelerate as well ensuring that any effects due to the decortication process itself are not attributed to the novel treatment.Instead of the collagen scaffold, participants of this group will receive a Deepitelized Free Gingival Graft (DFGG), which is a well-established technique for increasing a soft tissue volume and treating gingival recession. The DFGG serves as a standard comparison to evaluate the added benefit, if any of the collagen scaffold used in the intervention group.
Treatment methods:
Intervention Group: Collagen Scaffold with Piezocision
Piezcision:
Procedure: Decortication in alveolar bone was done using piezotome handpiece with piezo surgical knife, precise and selective vertical corticotomy grooves which are about 1.5-2 mm in depth will be made in the cortical bone around teeth that are targeted for movement in the interradicular area.
Technique: A minimally invasive full thickness flap will be raised to expose the alveolar bone. Vertical corticotomy grooves will be performed in strategic locations to accelerate orthodontic tooth movement.
Parameters: Vertical corticotomy grooves will be performed in strategic locations in the interradicular area which are about 1.5-2 mm in depth by gently working around the root of the tooth without damaging it, and distribution of the cuts will be standardized based on the best available evidence and will be documented for each patient.
Collagen Scaffold (Osssix VOLUMAX):
Application: After the decortication, the collagen scaffold will be applied directly onto the bone surface.
Characteristics: The scaffold is composed sugar cross-linked of byoresobable collagene 1 type (porcine), 1.5 mm thikness, resorption time 4 month.
Post-Operative Care: Standardized instructions will be provided for home care, including oral hygiene and medication, if any, to support scaffold integration.
- Conditions
- Dental Crowding, Gingival Recession, Thin Phenotype
- Being tested
- Piezocision with ribose cross-linked collagen matrix (Ossix® Volumax), control
- Keywords
- Corticotomy, Soft Tissue Augmantation, Bone Augmentation, Ossix Volume, Collagene Scaffold, Orthodontics, Piezocision
- Medical subject headings
- Crowding, Gingival Recession
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Piezocision with ribose cross-linked collagen matrix (Ossix® Volumax)Procedure or surgery
Also called Volumax, Ribose cross-linked collagen scaffold, Ossix collagen matrix
A full-thickness mucoperiosteal flap will be elevated to expose the alveolar bone. Vertical corticotomy grooves (piezocision) will be created in strategic locations to accelerate orthodontic tooth movement. The Ossix® Volumax collagen matrix will be trimmed and applied directly onto the decorticated bone surface to support bone regeneration and soft tissue augmentation.
controlProcedure or surgery
A minimally invasive full thickness flap will be raised to expose the alveolar bone. Vertical corticotomy grooves will be performed in strategic locations to accelerate orthodontic tooth movement. The Deepitelized Free Gingival Graft (DFGG) will be placed and secured over the areas of decortication to promote soft tissue healing and augmentation.
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | Description of Arm:
This group will receive the novel treatment combination. Participants will undergo piezocision-a minimally invasive surgical technique that creates vertical corticotomy grooves in the alveolar bone to stimulate bone remodeling and accelerate orthodontic tooth movement. In addition, a ribose cross-linked collagen matrix (Ossix® Volumax) will be applied over the decorticated bone surface. All participants are undergoing active orthodontic treatment with fixed appliances prior to the surgical procedure.
Intervention Name:
Procedure/Surgery: Piezocision with ribose cross-linked collagen matrix (Ossix® Volumax)
Intervention Description:
A minimally invasive full-thickness flap will be elevated to expose the alveolar bone. Vertical corticotomy grooves (piezocision) will be performed in strategic locations. The collagen matrix (Ossix® Volumax) will be trimmed and applied over the exposed decorticated bone to support bone and soft tissue regeneration.
Other Name(s): Receives: Procedure: Piezocision with ribose cross-linked collagen matrix (Ossix® Volumax) |
| Control | Active comparator | Description of Arm:
This group will receive the control treatment. Piezocision will be performed similarly to the experimental group, creating vertical corticotomy grooves to accelerate tooth movement. However, instead of a collagen matrix, participants will receive a deepithelialized free gingival graft (DFGG) harvested from the palatal mucosa. This well-established technique is commonly used to increase gingival thickness and volume and serves as a comparator for evaluating the potential added benefit of the collagen scaffold.
Intervention Name:
Procedure/Surgery: Piezocision with deepithelialized free gingival graft (DFGG)
Intervention Description:
A full-thickness mucoperiosteal flap will be elevated to expose the alveolar bone. Vertical corticotomy grooves will be created (piezocision) in strategic locations to accelerate orthodontic tooth movement. A deepithelialized free gingival graft harvested from the palate will then be placed and stabilized over the decorticated bone Receives: Procedure: control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Increase in Gingival Thickness and Alveolar Bone Volume
The primary endpoint is the quantifiable increase in gingival thickness and alveolar bone volume at the sites of orthodontic intervention. Gingival thickness will be defined as the distance from the gingival margin to the alveolar bone crest, and bone volume will be measured in cubic millimeters.
Measured: Baseline measurements will be taken prior to the surgical intervention. Subsequent measurements will be taken at 1 month, 6 months, and 1 year post-surgery. Each measurement will be conducted by blinded examiners to maintain objectivity.
Secondary outcomes (4)
Risk Reduction of Gingival Recession
A decrease in the incidence of gingival recession post-treatment, characterized by the exposure of the roots of the teeth as measured from the cementoenamel junction (CEJ) to the gingival margin.
Measured: Clinical periodontal probing and intraoral photographs will be used to measure and document changes in the gingival margin position.Measurements will be taken at baseline and at each subsequent follow-up visit, with comparison to pre-treatment levels.
Decrease in Duration of Surgery
This refers to the actual time taken to complete the surgical aspect of the treatment, from the initial incision to the final suture or equivalent closing procedure.
Measured: Surgical duration will be precisely recorded in minutes by the operating team.
Orthodontic Treatment Time
The time required from the initiation of orthodontic appliance placement to the achievement of the desired dental alignment and occlusion
Measured: Treatment duration will be monitored continuously, with records updated at each patient visit.
Patient Satisfaction and Quality of Life
This endpoint assesses the patient's subjective satisfaction with the treatment outcomes and the impact on their quality of life.
Measurement Tools: Validated questionnaires such as the Oral Health Impact Profile (OHIP) and patient satisfaction surveys will be utilized.
Measured: Surveys will be administered at 6 months and 1 year post-treatment to capture both short- term and long-term satisfaction and quality of life.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jul 2025
- Study start25 Jun 2024
- Primary completion25 Sep 2025 (estimated)
- Study completion25 Sep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dental CrowdingStudies 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Intervention Group: Participants in this arm will undergo piezocisions, a minimally invasive surgical technique that aids in orthodontic tooth movement by creating vertical corticotomy grooves in the alveolar bone to facilitate its remodeling. Along with this procedure, a Collagen Scaffold will be applied. The scaffold is likely designed to support the regeneration of bone and soft tissue, potentially enhancing the effects of the decortication . The control group will receive piezocisions will be performed in strategic locations to accelerate as well ensuring that any effects due to the decortication process itself are not attributed to the novel treatment.Instead of the collagen scaffold, participants of this group will receive a Deepitelized Free Gingival Graft (DFGG), which is a well-established technique for increasing a soft tissue volume and treating gingival recession.
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- NMSI DENTMASTER
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07097714
- Sponsor's protocol ID
- ДМ003
- Status last verified
- Jul 2025
- First submitted
- 10 Apr 2024
- Last updated
- 31 Jul 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: IPD will not be shared due to the single-patient nature of the study and associated confidentiality limitations.
Study at a glance
From the registry record, last updated by the sponsor on 31 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluating the Clinical Efficacy of Collagen Scaffold (Ossix VOLUMAX) With Piezo-Surgical Decortication in Enhancing Orthodontic Treatment Outcomes: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07097714
- Acronym / sponsor ID
- ДМ003
- Conditions
- Dental Crowding, Gingival Recession, Thin Phenotype
- Keywords
- Corticotomy, Soft Tissue Augmantation, Bone Augmentation, Ossix Volume, Collagene Scaffold, Orthodontics, Piezocision
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- NMSI DENTMASTERUniversity, hospital or other
- Study start
- 25 Jun 2024 (actual)
- Primary completion
- 25 Sep 2025 (estimated)
- Study completion
- 25 Sep 2026 (estimated)
- First posted
- 31 Jul 2025 (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.
Recent advances in orthodontic treatment have explored various materials to enhance treatment efficacy, particularly focusing on collagen scaffolds. Collagen, being a primary component of the bone matrix, has garnered attention for its biocompatibility, cell adhesion, and osteoconductivity properties. Studies have shown that collagen scaffolds undergo natural degradation, mimicking biological processes, and play a significant role in tissue engineering (International Journal of Implant Dentistry, 2023). This aligns with the growing interest in minimally invasive methods that accelerate orthodontic treatment and improve tissue regeneration.
In this context, the application of collagen scaffolds, such as Ossix VOLUMAX, in conjunction with piezo-surgical decortication, presents a novel approach. This study aims to build upon the existing knowledge, exploring the efficacy of collagen scaffolds in enhancing orthodontic treatment outcomes, especially in patients with specific dental conditions like a thin gingival phenotype and malocclusion. The study\'s hypothesis is grounded in the promising properties of collagen-based materials in dental and orthodontic applications, as evidenced by recent research in the field.
Detailed description
Hypothesis:
The application of a Collagen Scaffold (Ossix VOLUMAX) in conjunction with piezo- surgical decortication enhances the efficacy of orthodontic treatment by increasing the thickness of gingiva and volume of alveolar bone in adults with a thin phenotype of gingiva and malocclusion, particularly in the mandibular incisors, more effectively than piezo- surgical decortication with a connective tissue graft alone. This combined treatment also reduces morbidity, decreases the risk of gingival recessions, and shortens the duration of surgery compared to the control group.
Study Groups:
In this clinical trial, the participants are divided into two groups to compare the outcomes of different surgical interventions in conjunction with orthodontic treatment:
Intervention Group:
This group will receive the novel treatment combination. Participants in this arm will undergo piezocisions, a minimally invasive surgical technique that aids in orthodontic tooth movement by creating vertical corticotomy grooves in the alveolar bone to facilitate its remodeling. Along with this procedure, a Collagen Scaffold (specifically, Ossix VOLUMAX) will be applied. The scaffold is likely designed to support the regeneration of bone and soft tissue, potentially enhancing the effects of the decortication and improving clinical outcomes such as bone volume and gingival thickness.
Control Group:
The control group will receive piezocisions will be performed in strategic locations to accelerate as well ensuring that any effects due to the decortication process itself are not attributed to the novel treatment.Instead of the collagen scaffold, participants of this group will receive a Deepitelized Free Gingival Graft (DFGG), which is a well-established technique for increasing a soft tissue volume and treating gingival recession. The DFGG serves as a standard comparison to evaluate the added benefit, if any of the collagen scaffold used in the intervention group.
Treatment methods:
Intervention Group: Collagen Scaffold with Piezocision
Piezcision:
Procedure: Decortication in alveolar bone was done using piezotome handpiece with piezo surgical knife, precise and selective vertical corticotomy grooves which are about 1.5-2 mm in depth will be made in the cortical bone around teeth that are targeted for movement in the interradicular area.
Technique: A minimally invasive full thickness flap will be raised to expose the alveolar bone. Vertical corticotomy grooves will be performed in strategic locations to accelerate orthodontic tooth movement.
Parameters: Vertical corticotomy grooves will be performed in strategic locations in the interradicular area which are about 1.5-2 mm in depth by gently working around the root of the tooth without damaging it, and distribution of the cuts will be standardized based on the best available evidence and will be documented for each patient.
Collagen Scaffold (Osssix VOLUMAX):
Application: After the decortication, the collagen scaffold will be applied directly onto the bone surface.
Characteristics: The scaffold is composed sugar cross-linked of byoresobable collagene 1 type (porcine), 1.5 mm thikness, resorption time 4 month.
Post-Operative Care: Standardized instructions will be provided for home care, including oral hygiene and medication, if any, to support scaffold integration.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
- Model description
- Intervention Group: Participants in this arm will undergo piezocisions, a minimally invasive surgical technique that aids in orthodontic tooth movement by creating vertical corticotomy grooves in the alveolar bone to facilitate its remodeling. Along with this procedure, a Collagen Scaffold will be applied. The scaffold is likely designed to support the regeneration of bone and soft tissue, potentially enhancing the effects of the decortication . The control group will receive piezocisions will be performed in strategic locations to accelerate as well ensuring that any effects due to the decortication process itself are not attributed to the novel treatment.Instead of the collagen scaffold, participants of this group will receive a Deepitelized Free Gingival Graft (DFGG), which is a well-established technique for increasing a soft tissue volume and treating gingival recession.
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Procedure: Piezocision with ribose cross-linked collagen matrix (Ossix® Volumax)Description of Arm: This group will receive the novel treatment combination. Participants will undergo piezocision-a minimally invasive surgical technique that creates vertical corticotomy grooves in the alveolar bone to stimulate bone remodeling and accelerate orthodontic tooth movement. In addition, a ribose cross-linked collagen matrix (Ossix® Volumax) will be applied over the decorticated bone surface. All participants are undergoing active orthodontic treatment with fixed appliances prior to the surgical procedure. Intervention Name: Procedure/Surgery: Piezocision with ribose cross-linked collagen matrix (Ossix® Volumax) Intervention Description: A minimally invasive full-thickness flap will be elevated to expose the alveolar bone. Vertical corticotomy grooves (piezocision) will be performed in strategic locations. The collagen matrix (Ossix® Volumax) will be trimmed and applied over the exposed decorticated bone to support bone and soft tissue regeneration. Other Name(s): |
| Control | Active comparator | Procedure: controlDescription of Arm: This group will receive the control treatment. Piezocision will be performed similarly to the experimental group, creating vertical corticotomy grooves to accelerate tooth movement. However, instead of a collagen matrix, participants will receive a deepithelialized free gingival graft (DFGG) harvested from the palatal mucosa. This well-established technique is commonly used to increase gingival thickness and volume and serves as a comparator for evaluating the potential added benefit of the collagen scaffold. Intervention Name: Procedure/Surgery: Piezocision with deepithelialized free gingival graft (DFGG) Intervention Description: A full-thickness mucoperiosteal flap will be elevated to expose the alveolar bone. Vertical corticotomy grooves will be created (piezocision) in strategic locations to accelerate orthodontic tooth movement. A deepithelialized free gingival graft harvested from the palate will then be placed and stabilized over the decorticated bone |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (0 listed)
Key exclusion criteria (1 listed)
- Existing Periodontal Disease: Individuals with active periodontal disease or significant periodontal bone loss that contraindicates orthodontic treatment.
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 |
|---|---|---|
| Piezocision with ribose cross-linked collagen matrix (Ossix® Volumax)Also: Volumax, Ribose cross-linked collagen scaffold, Ossix collagen matrixA full-thickness mucoperiosteal flap will be elevated to expose the alveolar bone. Vertical corticotomy grooves (piezocision) will be created in strategic locations to accelerate orthodontic tooth movement. The Ossix® Volumax collagen matrix will be trimmed and applied directly onto the decorticated bone surface to support bone regeneration and soft tissue augmentation. | Procedure or surgery | Intervention |
| controlA minimally invasive full thickness flap will be raised to expose the alveolar bone. Vertical corticotomy grooves will be performed in strategic locations to accelerate orthodontic tooth movement. The Deepitelized Free Gingival Graft (DFGG) will be placed and secured over the areas of decortication to promote soft tissue healing and augmentation. | Procedure or surgery | Control |
Primary outcome
Increase in Gingival Thickness and Alveolar Bone Volume
Time frame: Baseline measurements will be taken prior to the surgical intervention. Subsequent measurements will be taken at 1 month, 6 months, and 1 year post-surgery. Each measurement will be conducted by blinded examiners to maintain objectivity.
The primary endpoint is the quantifiable increase in gingival thickness and alveolar bone volume at the sites of orthodontic intervention. Gingival thickness will be defined as the distance from the gingival margin to the alveolar bone crest, and bone volume will be measured in cubic millimeters.
4 secondary outcomes
Risk Reduction of Gingival Recession
Time frame: Clinical periodontal probing and intraoral photographs will be used to measure and document changes in the gingival margin position.Measurements will be taken at baseline and at each subsequent follow-up visit, with comparison to pre-treatment levels.
Decrease in Duration of Surgery
Time frame: Surgical duration will be precisely recorded in minutes by the operating team.
Orthodontic Treatment Time
Time frame: Treatment duration will be monitored continuously, with records updated at each patient visit.
Patient Satisfaction and Quality of Life
Time frame: Surveys will be administered at 6 months and 1 year post-treatment to capture both short- term and long-term satisfaction and quality of life.
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 31 Jul 2025.
- Individual participant dataSharing planned: No. IPD will not be shared due to the single-patient nature of the study and associated confidentiality limitations.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Piezocision with ribose cross-linked collagen matrix (Ossix® Volumax) in people with Dental Crowding and Gingival Recession, run by NMSI DENTMASTER at 1 site in Russia.
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 0 inclusion and 1 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 31 Jul 2025. 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 Russia. 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?
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 Tatiana Gatilova Tatyana Andreevna (0079529399919, tagatilova@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Increase in Gingival Thickness and Alveolar Bone Volume (time frame: Baseline measurements will be taken prior to the surgical intervention. Subsequent measurements will be taken at 1 month, 6 months, and 1 year post-surgery. Each measurement will be conducted by blinded examiners to maintain objectivity.). 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 31 Jul 2025.