Implant DentistryNCT07892820
Evaluation of Different Grafting Technique of Thin Gingival Phenotype With Delayed Dental Implants
A study testing De-epithelized connective tissue graft and Sub-epithelized connective tissue graft in people with Implant Dentistry and Connective Tissue Graft, run by Future University in Egypt at 1 site in Egypt.
Trial summary
Implant dentistry has become a fundamental aspect of modern dental practice, with its success now determined by more than just Osseo integration. Various factors play a critical role in the long-term success of dental implants, one of the most important being the stability of the peri-implant soft tissues, which are… Read more about this study
- Who is it for?
- Ages 20 to 50 years
- Conditions the study is for
- Implant Dentistry, Connective Tissue Graft
- What is being tested?
- De-epithelized connective tissue graft and Sub-epithelized connective tissue graft
- Type of treatment
- Pill or oral medicine, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteEgypt
- Study dates
- 30 Jan 2025to 30 Jan 2027
- 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 20 to 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Thin gingival phenotype < 1.5mm.[6]
- Medical free.
- Single edentulous area.
- Age range is between 20 to 50 years.
- Gingival recession.
- Free from any periodontal disease.
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- Positive patient's acceptance for participating in the study.
- Patients able to sign informed consent.
- Non-smokers.
- Moderate palatal vault.
- Thickness of palatal graft not <2mm.
- Width of bone not <8mm.
Who cannot join
- Psychologically disturbed patients.
- Patients with a history of allergy to any medication used in the study were excluded.
- Osteoporosis.
- Parafunctional habit.
- Patients taking anticoa
- Gulant therapy.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Egypt1 site, 1 recruiting
- Recruiting
Future University in Egypt
Cairo
Hossam Rushdy Master Candidate, Bachelor Degree, +20 11 55436000, Hosam.Roshdy.1996@hotmail.com
About this study
Official title: The Effect of De-epithelized Connective Tissue Graft Versus Sub-epithelized Connective Tissue Graft in Management of Thing Gingival Phenotype With Delayed Implants
Implant dentistry has become a fundamental aspect of modern dental practice, with its success now determined by more than just Osseo integration. Various factors play a critical role in the long-term success of dental implants, one of the most important being the stability of the peri-implant soft tissues, which are essential for maintaining both function and aesthetics. This study aims to compare the outcomes of sub epithelial connective tissue grafts and de-epithelialized connective tissue grafts in conjunction with delayed implant placement.
- Conditions
- Implant Dentistry, Connective Tissue Graft
- Being tested
- De-epithelized connective tissue graft, Sub-epithelized connective tissue graft
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
De-epithelized connective tissue graftProcedure or surgery
A free gingival graft will be harvested, de-epithelialized extra-orally, producing a 1.5 mm thick connective tissue graft. The graft will be inserted into the buccal pouch and will be sutured with resorbable sutures. Gel foam will be placed in the donor site and sutured, with a stent fixed in place.
Sub-epithelized connective tissue graftProcedure or surgery
A free gingival graft will be harvested,and sub-epithelized intra-orally, producing a 1.5 mm thick connective tissue graft. The graft will be inserted into the buccal pouch and will be sutured with resorbable sutures. Gel foam will be placed in the donor site and sutured, with a stent fixed in place.
| Study group | Role | What they receive |
|---|---|---|
| De-epithelized connective tissue graft with thin gingival phenotype with delayed implant placement. | Experimental | Not described Receives: Procedure: De-epithelized connective tissue graft |
| Sub-epithelized connective tissue graft | Active comparator | Not described Receives: Procedure: Sub-epithelized connective tissue graft |
What is being measured
The primary outcome is the main question the study is designed to answer.
Gingival index
Soft tissue healing clinical examination:
Gingival Index (GI): Assessed using the Löe and Silness Index (scored on a 0-3 scale:
0 - Normal gingiva
- - Mild inflammation: slight color change, slight edema, no bleeding on probing
- - Moderate inflammation: redness, edema, glazing, bleeding on probing
- - Severe inflammation: marked redness, edema, ulceration, tendency toward spontaneous bleeding
Measured: baseline before intervention and 6 months following intervention
Secondary outcomes (1)
Bone Density
CBCT radiographic examination
Measured: baseline before intervention and 6 months following intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Oct 2026
- Study start30 Jan 2025
- Primary completion31 Dec 2026 (estimated)
- Study completion30 Jan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Implant DentistryStudies 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
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 24 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Future University in Egypt
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hossam Rushdy Al Araby, Future University in Egypt
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07892820
- Sponsor's protocol ID
- FUE.(REC)(8)/1-2025
- Status last verified
- Oct 2026
- First submitted
- 18 Oct 2026
- Last updated
- 29 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- 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 29 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of De-epithelized Connective Tissue Graft Versus Sub-epithelized Connective Tissue Graft in Management of Thing Gingival Phenotype With Delayed Implants
- ClinicalTrials.gov ID
- NCT07892820
- Acronym / sponsor ID
- FUE.(REC)(8)/1-2025
- Conditions
- Implant Dentistry, Connective Tissue Graft
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- Future University in EgyptUniversity, hospital or other
- Study start
- 30 Jan 2025 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 30 Jan 2027 (estimated)
- First posted
- 23 Oct 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.
Implant dentistry has become a fundamental aspect of modern dental practice, with its success now determined by more than just Osseo integration. Various factors play a critical role in the long-term success of dental implants, one of the most important being the stability of the peri-implant soft tissues, which are essential for maintaining both function and aesthetics. This study aims to compare the outcomes of sub epithelial connective tissue grafts and de-epithelialized connective tissue grafts in conjunction with delayed implant placement.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| De-epithelized connective tissue graft with thin gingival phenotype with delayed implant placement. | Experimental | Procedure: De-epithelized connective tissue graft |
| Sub-epithelized connective tissue graft | Active comparator | Procedure: Sub-epithelized connective tissue graft |
Who may qualify
- Ages
- 20 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (12 listed)
- Thin gingival phenotype < 1.5mm.[6]
- Medical free.
- Single edentulous area.
- Age range is between 20 to 50 years.
- Gingival recession.
Key exclusion criteria (6 listed)
- Psychologically disturbed patients.
- Patients with a history of allergy to any medication used in the study were excluded.
- Osteoporosis.
- Parafunctional habit.
- Patients taking anticoa
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 |
|---|---|---|
| De-epithelized connective tissue graftA free gingival graft will be harvested, de-epithelialized extra-orally, producing a 1.5 mm thick connective tissue graft. The graft will be inserted into the buccal pouch and will be sutured with resorbable sutures. Gel foam will be placed in the donor site and sutured, with a stent fixed in place. | Procedure or surgery | De-epithelized connective tissue graft with thin gingival phenotype with delayed implant placement. |
| Sub-epithelized connective tissue graftA free gingival graft will be harvested,and sub-epithelized intra-orally, producing a 1.5 mm thick connective tissue graft. The graft will be inserted into the buccal pouch and will be sutured with resorbable sutures. Gel foam will be placed in the donor site and sutured, with a stent fixed in place. | Procedure or surgery | Sub-epithelized connective tissue graft |
Primary outcome
Gingival index
Time frame: baseline before intervention and 6 months following intervention
Soft tissue healing clinical examination: Gingival Index (GI): Assessed using the Löe and Silness Index (scored on a 0-3 scale: 0 - Normal gingiva 1. - Mild inflammation: slight color change, slight edema, no bleeding on probing 2. - Moderate inflammation: redness, edema, glazing, bleeding on probing 3. - Severe inflammation: marked redness, edema, ulceration, tendency toward spontaneous bleeding
1 secondary outcome
Bone Density
Time frame: baseline before intervention and 6 months following intervention
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 29 Oct 2026.
- Individual participant dataSharing planned: Undecided
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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 De-epithelized connective tissue graft and Sub-epithelized connective tissue graft in people with Implant Dentistry and Connective Tissue Graft, run by Future University in Egypt 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 12 inclusion and 6 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 29 Oct 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?
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 Hossam Rushdy Master Candidate, Bachelor Degree (+20 11 55436000, Hosam.Roshdy.1996@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Gingival index (time frame: baseline before intervention and 6 months following intervention). 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 29 Oct 2026.