Soft Tissue AugmentationNCT07434297
Pontic Site Soft Tissue Augmentation Using De-epithelized Connective Tissue Graft Versus Partially De-epithelized Connective Tissue Graft
A study testing Intervention in people with Soft Tissue Augmentation and Pontic Site Development, run by October University for Modern Sciences and Arts at 1 site in Egypt.
Trial summary
a comparative study to evaluate the pontic site soft tissue augmentation by partially de-epithelized connective tissue graft versus completely de-epithelized connective tissue graft (both grafts harvested from the hard palate). Read more about this study
- Who is it for?
- Ages 20 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Soft Tissue Augmentation, Pontic Site Development
- What is being tested?
- Intervention
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteEgypt
- Study dates
- 20 Dec 2024to 2 Feb 2026
- 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 20 to 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- age 20-45 years
- medically free
- bounded missing teeth
- patient accepting the fixed prosthetics as a treatment option
- restorable adjacent abutments
- periodontally healthy adjacent abutments
- motivated patient to have the treatment
- bleeding and plaque index less than 20%
Who cannot join
- systemic diseases
- smoking
- pregnancy
- patients with pervious soft tissue grafting
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Assessment of Soft Tissue Profile After Pontic Site Development Using De-Epithelized Connective Tissue Graft Versus Partially De-Epithelized Connective Tissue Graft: A Randomized Controlled Clinical Trial.
a comparative study to evaluate the pontic site soft tissue augmentation by partially de-epithelized connective tissue graft versus completely de-epithelized connective tissue graft (both grafts harvested from the hard palate). pontic site soft tissue augmentation allows the correction of soft tissue to allow proper fixed dental bridge fabrication (for esthetic and functional purposes)
- Conditions
- Soft Tissue Augmentation, Pontic Site Development
- Being tested
- Intervention, Control
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
InterventionProcedure or surgery
de-epithelized connective tissue graft for soft tissue augmentation for pontic site development
ControlProcedure or surgery
partially de-epithelized connective tissue graft for soft tissue grafting for pontic site development
| Study group | Role | What they receive |
|---|---|---|
| intervention (using autogenous de-epithelized connective tissue graft for pontic site) | Other | intervention (using autogenous de-epithelized connective tissue graft for pontic site soft tissue augmentation Receives: Procedure: Intervention |
| control group ( partially De-Epithelized connective tissue graft ) | Other | control group ( partially autogenous De-Epithelized connective tissue graft ) Receives: Procedure: Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
keratinized tissue thickness
Measured: time of enrollment, 3 and 6 months postoperative
Secondary outcomes (2)
soft tissue healing index
Measured: 6 months postoperative
Pain score
Measured: 3 and 7 days postoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Feb 2026
- Study start20 Dec 2024
- Primary completion1 Feb 2026
- Study completion2 Feb 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Soft Tissue AugmentationStudies 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
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- October University for Modern Sciences and Arts
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07434297
- Sponsor's protocol ID
- 9.1.1
- Status last verified
- Jan 2025
- First submitted
- 12 Jan 2026
- Last updated
- 25 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 25 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Soft Tissue Profile After Pontic Site Development Using De-Epithelized Connective Tissue Graft Versus Partially De-Epithelized Connective Tissue Graft: A Randomized Controlled Clinical Trial.
- ClinicalTrials.gov ID
- NCT07434297
- Acronym / sponsor ID
- 9.1.1
- Conditions
- Soft Tissue Augmentation, Pontic Site Development
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- October University for Modern Sciences and ArtsUniversity, hospital or other
- Study start
- 20 Dec 2024 (actual)
- Primary completion
- 1 Feb 2026 (actual)
- Study completion
- 2 Feb 2026 (actual)
- First posted
- 25 Feb 2026 (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.
a comparative study to evaluate the pontic site soft tissue augmentation by partially de-epithelized connective tissue graft versus completely de-epithelized connective tissue graft (both grafts harvested from the hard palate). pontic site soft tissue augmentation allows the correction of soft tissue to allow proper fixed dental bridge fabrication (for esthetic and functional purposes)
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| intervention (using autogenous de-epithelized connective tissue graft for pontic site) | Other | Procedure: Interventionintervention (using autogenous de-epithelized connective tissue graft for pontic site soft tissue augmentation |
| control group ( partially De-Epithelized connective tissue graft ) | Other | Procedure: Controlcontrol group ( partially autogenous De-Epithelized connective tissue graft ) |
Who may qualify
- Ages
- 20 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- age 20-45 years
- medically free
- bounded missing teeth
- patient accepting the fixed prosthetics as a treatment option
- restorable adjacent abutments
Key exclusion criteria (4 listed)
- systemic diseases
- smoking
- pregnancy
- patients with pervious soft tissue grafting
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 |
|---|---|---|
| Interventionde-epithelized connective tissue graft for soft tissue augmentation for pontic site development | Procedure or surgery | intervention (using autogenous de-epithelized connective tissue graft for pontic site) |
| Controlpartially de-epithelized connective tissue graft for soft tissue grafting for pontic site development | Procedure or surgery | control group ( partially De-Epithelized connective tissue graft ) |
Primary outcome
keratinized tissue thickness
Time frame: time of enrollment, 3 and 6 months postoperative
2 secondary outcomes
soft tissue healing index
Time frame: 6 months postoperative
Pain score
Time frame: 3 and 7 days postoperative
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 25 Feb 2026.
- Individual participant dataSharing planned: Undecided
Related trials for Soft Tissue Augmentation
Recruiting
Evaluating the Barrier Function, Regenerative Capacity, and Soft Tissue Outcomes of Acellular Dermal Matrix
Acellular Dermal Matrix, Bone Grafting
Not yet recruiting
Sandwich vs. Mixed Bone Augmentation for Implant Placement
Peri-implant Bone and Soft Tissues
Not yet recruitingPhase 1/2
Alveolar Ridge Preservation (ARP) Study Using Alloplastic Biomaterial and a Resorbable Synthetic Membrane. A Digital Workflow (CBCT/Scanner) Evaluates Hard and Soft Tissue Volumetric Changes at 4 Months, Validating Support for the Gingival Phenotype and Buccal Bone Plate.
Alveolar Ridge Augmentation, Bone Substitutes
Not yet recruiting
Evaluation of the Effect of Smoking on Palatal Donor Site Tissue Profile in the Success of Connective Tissue Grafts
Soft Tissue Augmentation, Gingival Recession Localized Moderate
Not yet recruiting
Keratinized Tissue Augmentation Using Augmented Gingival Matrix Compared to Free Gingival Graft Around Implants
Keratinized Tissue Augmentation Around Dental Implants
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intervention in people with Soft Tissue Augmentation and Pontic Site Development, run by October University for Modern Sciences and Arts at 1 site in Egypt.
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 8 inclusion and 4 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 25 Feb 2026. 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 Egypt. 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?
keratinized tissue thickness (time frame: time of enrollment, 3 and 6 months postoperative). 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 25 Feb 2026.