Free Gingival GraftNCT06645925
Tissue Augmentation Technique Using Free Gingival Graft Simultaneous With Posterior Mandibular Implant
A study testing One Step Protocol and Two Steps Protocol in people with Free Gingival Graft and Free Gingival Graft Volume Change, run by Misr International University at 1 site in Egypt.
Trial summary
Presence of keratinized tissue (KT) around dental implants, plays a crucial role in stability and health of peri-implant tissues. Several studies reported that, minimum of 2 mm keratinized tissue width is required to achieve long-term longevity. Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Free Gingival Graft, Free Gingival Graft Volume Change, Keratinized Tissue
- What is being tested?
- One Step Protocol and Two Steps Protocol
- 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
- 1 Nov 2024to 30 Dec 2025
- 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 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Adults at or above the age of 18.
- Lower Posterior missing tooth/ teeth with minimal KT \< 2mm
- Sufficient alveolar ridge length minimum 13-15 mm to IAN
- •. Sufficient alveolar ridge width minimum of 6 mm
- Patients able to tolerate surgical periodontal procedures.
- Patients who provided an informed consent and accepted the one-year follow-up period.
Who cannot join
- Patients diagnosed with periodontal diseases (Caton et al., 2018).
- Current or previous smokers.
- Pregnant and lactating females.
- Patients with medical conditions that would compromise the surgical procedures; uncontrolled diabetes mellitus, taking intravenous Bisphosphonates for treatment of osteoporosis.
- Patients with active infection related to the site of implant.
- Patients with parafunctional habits.
- Patients with shallow vestibule
Trial locations and contacts
1 site in 1 country.
Egypt1 site
International Dental Continuing Education
Cairo, Cairo Governorate, 11347
About this study
Official title: Soft Tissue Augmentation Technique Using Free Gingival Graft Simultaneous With Implant Placement in Posterior Mandible: A 1-year Randomized Clinical Trial
Presence of keratinized tissue (KT) around dental implants, plays a crucial role in stability and health of peri-implant tissues. Several studies reported that, minimum of 2 mm keratinized tissue width is required to achieve long-term longevity. Insufficient keratinized mucosa leads to biofilm accumulation, soft tissue inflammation, eventually peri-implant mucositis and peri-implantitis. Hence, the aim of the present trial is to evaluate KTW gain, linear and volumetric changes in buccal soft tissue along with hard tissue alterations following implant restoration at sites treated either with delayed implant placement \&amp; simultaneous FGG or the conventional FGG protocol prior to implant placement.
- Being tested
- One Step Protocol, Two Steps Protocol
- Keywords
- FGG, Delayed implant placement, Keratinized mucosa
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
One Step ProtocolProcedure or surgery
FGG will be done simultaneous with implant placement
Two Steps ProtocolProcedure or surgery
Conventional FGG protocol, prior to implant placement
| Study group | Role | What they receive |
|---|---|---|
| One Step Protocol | Experimental | FGG simultaneous with delayed implant placement Receives: Procedure: One Step Protocol |
| Two Steps protocol | Active comparator | Conventional FGG protocol, prior to implant placement Receives: Procedure: Two Steps Protocol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Keratinized tissue width
Optical scans using intraoral scanner (Runyes® Model V5) were obtained at baseline, 3, 6 and 12 months post-operative for each patient. All the optical scans in standard tessellation language (STL) format, were imported to the digital software (Exocad). The best-fit algorithm was used to superimpose digital surface models, when comparing each area of interest (AOI) throughout out the follow up period. KTW (mm) was measured from the preoperative MGJ to the new MGJ using distance measurement tool in the software. KTW measurements were taken at mesial, mid-buccal and distal sites on the buccal side of the implant, values at the three sites were then averaged. Difference between KTW baseline and KTW follow-up was then analyzed to present the changes in KTW
Measured: 12 months
Secondary outcomes (3)
Bucco-lingual width bone changes
Postoperative CBCT evaluation was performed to all the recruited patients after 1 year to assess bucco-lingual (BL) bone width changes at three levels; at implant platform, 2mm and 5mm below the implant platform. To perform radiographic measurements and comparisons and to ensure standardization and reproducibility of the CBCT images, superimposition of DICOM file sets of each patient were done using Fusion module software (OnDemand3D ver, 1.0.9, Cybermed), which allowed sub-voxel accuracy. On the fusion module, both initial and postoperative volumes were superimposed and loaded at the same time. To measure the bucco-lingual (BL) bone width changes, the lingual surface of the implant was used as a reference point. A reference line was constructed along the lingual surface of the implant on the cross-sectional cut of the postoperative CBCT volume. Then, both baseline and postoperative CBCT volumes we
Measured: 12 Months
Survival Rate
Implant survival criteria were chosen according to Albrektsson et al. (1986). Surgical and prosthetic complications were also evaluated throughout the follow up timeline.
Measured: 12 Months
Total volume Changes
Total volume change (mm3) was calculated at 3 and 12 months postoperative via surface volume analysis within the AOI for each patient. The best-fit algorithm (iterative closet point algorithm) was used to superimpose digital surface models, when comparing each AOI throughout out the follow up periods. To measure the volume gain, the solid preoperative scans were subtracted from the follow-up scans using the Boolean operations software tool. This step will produce a new virtual object representing the volume gained. A three-dimensional (3D) inspection and metrology software (Geomagic Control X, 2022.1.0) was used to calculate the volume gain in mm3 using the measure volume tool.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Oct 2024
- Study start1 Nov 2024
- Primary completion30 Nov 2025
- Study completion30 Dec 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Free Gingival GraftStudies 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
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Misr International University
- Sponsor type
- University, hospital or other
- Collaborators
- International Dental Contiuing Education
- Responsible party
- Principal investigator, Ahmed Abo El Futtouh, International Dental Contiuing Education
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06645925
- Sponsor's protocol ID
- IDCE - 13
- Status last verified
- Aug 2026
- First submitted
- 5 Sep 2024
- Last updated
- 13 Aug 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 13 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Soft Tissue Augmentation Technique Using Free Gingival Graft Simultaneous With Implant Placement in Posterior Mandible: A 1-year Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT06645925
- Acronym / sponsor ID
- IDCE - 13
- Keywords
- FGG, Delayed implant placement, Keratinized mucosa
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Misr International UniversityUniversity, hospital or other
- Collaborators
- International Dental Contiuing Education
- Study start
- 1 Nov 2024 (actual)
- Primary completion
- 30 Nov 2025 (actual)
- Study completion
- 30 Dec 2025 (actual)
- First posted
- 17 Oct 2024 (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.
Presence of keratinized tissue (KT) around dental implants, plays a crucial role in stability and health of peri-implant tissues. Several studies reported that, minimum of 2 mm keratinized tissue width is required to achieve long-term longevity. Insufficient keratinized mucosa leads to biofilm accumulation, soft tissue inflammation, eventually peri-implant mucositis and peri-implantitis. Hence, the aim of the present trial is to evaluate KTW gain, linear and volumetric changes in buccal soft tissue along with hard tissue alterations following implant restoration at sites treated either with delayed implant placement \&amp; simultaneous FGG or the conventional FGG protocol prior to implant placement.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| One Step Protocol | Experimental | Procedure: One Step ProtocolFGG simultaneous with delayed implant placement |
| Two Steps protocol | Active comparator | Procedure: Two Steps ProtocolConventional FGG protocol, prior to implant placement |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Adults at or above the age of 18.
- Lower Posterior missing tooth/ teeth with minimal KT \< 2mm
- Sufficient alveolar ridge length minimum 13-15 mm to IAN
- •. Sufficient alveolar ridge width minimum of 6 mm
- Patients able to tolerate surgical periodontal procedures.
Key exclusion criteria (7 listed)
- Patients diagnosed with periodontal diseases (Caton et al., 2018).
- Current or previous smokers.
- Pregnant and lactating females.
- Patients with medical conditions that would compromise the surgical procedures; uncontrolled diabetes mellitus, taking intravenous Bisphosphonates for treatment of osteoporosis.
- Patients with active infection related to the site of implant.
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 |
|---|---|---|
| One Step ProtocolFGG will be done simultaneous with implant placement | Procedure or surgery | One Step Protocol |
| Two Steps ProtocolConventional FGG protocol, prior to implant placement | Procedure or surgery | Two Steps protocol |
Primary outcome
Keratinized tissue width
Time frame: 12 months
Optical scans using intraoral scanner (Runyes® Model V5) were obtained at baseline, 3, 6 and 12 months post-operative for each patient. All the optical scans in standard tessellation language (STL) format, were imported to the digital software (Exocad). The best-fit algorithm was used to superimpose digital surface models, when comparing each area of interest (AOI) throughout out the follow up period. KTW (mm) was measured from the preoperative MGJ to the new MGJ using distance measurement tool in the software. KTW measurements were taken at mesial, mid-buccal and distal sites on the buccal side of the implant, values at the three sites were then averaged. Difference between KTW baseline and KTW follow-up was then analyzed to present the changes in KTW
3 secondary outcomes
Bucco-lingual width bone changes
Time frame: 12 Months
Survival Rate
Time frame: 12 Months
Total volume Changes
Time frame: 12 months
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 13 Aug 2026.
- Individual participant dataSharing planned: No
Related trials for Free Gingival Graft
Recruiting
Palatal Wound Healing After Free Gingival Graft Harvest in Diabetic Patients: A Clinical Trial
Diabetes Mellitus, Gingival Recession, Generalized
Recruiting
Effects of Low-Level Laser Therapy and Hyaluronic Acid After Free Gingival Graft
Gingival Recession, Mucogingival Surgery
Not yet recruiting
Keratinized Tissue Augmentation Using Augmented Gingival Matrix Compared to Free Gingival Graft Around Implants
Keratinized Tissue Augmentation Around Dental Implants
Not yet recruiting
Comparison of the Keratinized Tissue Gain in Frenal Relocation Alone to Frenal Relocation Combined With the Application of Free Gingival Graft in High Frenum Attachment in Adults
Keratinized Tissue Gain
Not yet recruiting
Apical Flap Repositioning vs. Mucosa Excision With Free Gingival Grafts for Peri-Implant Keratinized Mucosa Augmentation
Keratinized Mucosa Deficiency, Peri-implant Soft Tissue
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 One Step Protocol and Two Steps Protocol in people with Free Gingival Graft and Free Gingival Graft Volume Change, run by Misr International 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 6 inclusion and 7 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 13 Aug 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 width (time frame: 12 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 13 Aug 2026.