Soft Tissue Augmentation at Dental ImplantsBFP - FGGNCT07327047
Autogenous Soft Tissue Grafts for Primary Closure Over Immediately Placed Dental Implants
A study testing Free autogenous soft tissue grafts in people with Soft Tissue Augmentation at Dental Implants and Marginal Bone Loss, run by Mansoura University at 1 site in Egypt.
Trial summary
The aim of this interventional study is to evaluate the best method to place the autogenous soft tissue grafts for primary closure over immediately-placed dental implants. Primary hypothesis, there is no differences between the two techniques of placement. Read more about this study
- Who is it for?
- Ages 18 to 45 years
- Conditions the study is for
- Soft Tissue Augmentation at Dental Implants, Marginal Bone Loss
- What is being tested?
- Free autogenous soft tissue grafts
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteEgypt
- Study dates
- 1 May 2025to 2 May 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 18 to 45 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Good oral hygiene.
- Medically free from systemic diseases that actually contraindicate implant surgery.
- Patient cooperation.
- The presence of the intact walls of the socket after tooth extraction.
Who cannot join
- General contraindications for dental and/or surgical treatments.
- Concurrent or previous radiotherapy of head area.
- Smoking.
- Pregnancy.
- Patients refused the procedure.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: How to Place Autogenous Soft Tissue Grafts Ideally for Primary Closure Over Immediately Placed Dental Implants? A Randomized Clinical Trial
The aim of this interventional study is to evaluate the best method to place the autogenous soft tissue grafts for primary closure over immediately-placed dental implants.
- Primary hypothesis, there is no differences between the two techniques of placement.
Read the detailed description
The peri-implant mucosa provides protection to the underlying bone via its immune response and protection from apical biofilm migration. An adequate band of attached keratinized mucosa limit early marginal bone loss and improved aesthetic outcomes around implant prostheses. There are several effective socket seal surgery (SSS) techniques to improve the clinical results in the preservation of the alveolar ridge and lessen bone resorption.
Autologous soft tissue grafts still provide the gold standard in gaining keratinized tissue and mucosal thickness compared to autologous substitutes on the market. Simultaneous soft tissue grafts at the time of implant placement can counteract the reduction in ridge width and maintain the ridge architecture regardless of the soft tissue phenotype at the site.
- Being tested
- Free autogenous soft tissue grafts
- Keywords
- Implantology, Buccal Fat Pad, Immediate Implant, Palatal Gingival Graft, Socket Seal, Soft tissue graft, Posterior Maxilla
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Free autogenous soft tissue graftsProcedure or surgery
Free autogenous soft tissue grafts (Buccal Pad Fat and Palatal Gingival Graft) that will be placed over immediately-placed dental implants
| Study group | Role | What they receive |
|---|---|---|
| Free autogenous soft tissue graft that will be placed without split thickness flaps | Other | Included 10 immediately-placed dental implants with free autogenous soft tissue graft that were placed without split thickness flaps. Receives: Procedure: Free autogenous soft tissue grafts |
| Free autogenous soft tissue graft that will be placed within the prepared split thickness flaps | Other | Included 10 immediately-placed dental implants with free autogenous soft tissue graft that were placed within the prepared split thickness flaps Receives: Procedure: Free autogenous soft tissue grafts |
What is being measured
The primary outcome is the main question the study is designed to answer.
Marginal Bone Loss
Marginal Bone Loss around immediately-placed dental implants will be measured in millimeters on cross-sectional view of CBCT
Measured: 6 months postoperative
Secondary outcomes (1)
Soft Tissue Healing
Using Pink Esthetic Score
Measured: At insertion of the prosthetic part (T0) After 2-month post-insertion of the prosthetic part
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jan 2026
- Study start1 May 2025
- Primary completion30 Mar 2026
- Study completion2 May 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Soft Tissue Augmentation at Dental ImplantsStudies 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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mansoura University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07327047
- Sponsor's protocol ID
- RP.25.05.3
- Acronym
- BFP - FGG
- Status last verified
- Aug 2026
- First submitted
- 26 Dec 2025
- Last updated
- 1 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- 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 1 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- How to Place Autogenous Soft Tissue Grafts Ideally for Primary Closure Over Immediately Placed Dental Implants? A Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT07327047
- Acronym / sponsor ID
- BFP - FGG / RP.25.05.3
- Keywords
- Implantology, Buccal Fat Pad, Immediate Implant, Palatal Gingival Graft, Socket Seal, Soft tissue graft, Posterior Maxilla
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Mansoura UniversityUniversity, hospital or other
- Study start
- 1 May 2025 (actual)
- Primary completion
- 30 Mar 2026 (actual)
- Study completion
- 2 May 2026 (actual)
- First posted
- 8 Jan 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.
The aim of this interventional study is to evaluate the best method to place the autogenous soft tissue grafts for primary closure over immediately-placed dental implants.
- Primary hypothesis, there is no differences between the two techniques of placement.
Detailed description
The peri-implant mucosa provides protection to the underlying bone via its immune response and protection from apical biofilm migration. An adequate band of attached keratinized mucosa limit early marginal bone loss and improved aesthetic outcomes around implant prostheses. There are several effective socket seal surgery (SSS) techniques to improve the clinical results in the preservation of the alveolar ridge and lessen bone resorption.
Autologous soft tissue grafts still provide the gold standard in gaining keratinized tissue and mucosal thickness compared to autologous substitutes on the market. Simultaneous soft tissue grafts at the time of implant placement can counteract the reduction in ridge width and maintain the ridge architecture regardless of the soft tissue phenotype at the site.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Free autogenous soft tissue graft that will be placed without split thickness flaps | Other | Procedure: Free autogenous soft tissue graftsIncluded 10 immediately-placed dental implants with free autogenous soft tissue graft that were placed without split thickness flaps. |
| Free autogenous soft tissue graft that will be placed within the prepared split thickness flaps | Other | Procedure: Free autogenous soft tissue graftsIncluded 10 immediately-placed dental implants with free autogenous soft tissue graft that were placed within the prepared split thickness flaps |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Good oral hygiene.
- Medically free from systemic diseases that actually contraindicate implant surgery.
- Patient cooperation.
- The presence of the intact walls of the socket after tooth extraction.
Key exclusion criteria (5 listed)
- General contraindications for dental and/or surgical treatments.
- Concurrent or previous radiotherapy of head area.
- Smoking.
- Pregnancy.
- Patients refused the procedure.
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 |
|---|---|---|
| Free autogenous soft tissue graftsFree autogenous soft tissue grafts (Buccal Pad Fat and Palatal Gingival Graft) that will be placed over immediately-placed dental implants | Procedure or surgery | Free autogenous soft tissue graft that will be placed within the prepared split thickness flaps, Free autogenous soft tissue graft that will be placed without split thickness flaps |
Primary outcome
Marginal Bone Loss
Time frame: 6 months postoperative
Marginal Bone Loss around immediately-placed dental implants will be measured in millimeters on cross-sectional view of CBCT
1 secondary outcome
Soft Tissue Healing
Time frame: At insertion of the prosthetic part (T0) After 2-month post-insertion of the prosthetic part
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 1 Sep 2026.
- 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Free autogenous soft tissue grafts in people with Soft Tissue Augmentation at Dental Implants and Marginal Bone Loss, run by Mansoura University 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 4 inclusion and 5 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 1 Sep 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?
Marginal Bone Loss (time frame: 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 1 Sep 2026.