Soft Tissue Thickness Around Delayed Implants in Patients With Thin Gingival PhenotypeNCT07368621
Effectiveness of Connective Tissue Graft With and Without Leukocyte Platelet Rich Fibrin on Peri-implant Soft Tissue Thickness Around Delayed Implants in Patients With Thin Gingival Phenotype: A Randomized Controlled Clinical Trial
A study testing Connective tissue graft(CTG) and Connective tissue graft (CTG) + leukocyte platelet-rich fibrin (L-PRF) in people with Soft Tissue Thickness Around Delayed Implants in Patients With Thin Gingival Phenotype, run by British University In Egypt at 1 site in Egypt.
Trial summary
A stable soft and hard tissues around Osseo-integrated implants are very crucial. Soft tissue thickness around implants is crucial as it prevents peri-implant bone loss and enhance the esthetic outcomes. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Soft Tissue Thickness Around Delayed Implants in Patients With Thin Gingival Phenotype
- What is being tested?
- Connective tissue graft(CTG) and Connective tissue graft (CTG) + leukocyte platelet-rich fibrin (L-PRF)
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 38 participants
- Where
- 1 siteEgypt
- Study dates
- 16 Jan 2026to 31 Jul 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 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 1. Patients between 18-60 years. 2. With thin gingival phenotype with a peri-implant mucosal thickness of less than 2mm28. With single missing tooth in the incisor, canine and premolar area. With the presence of two natural adjacent teeth and to not have a bone augmentation procedure before or during the dental implant.
- 3. Patient consent approval and signing 4. Medically free patients 5. Patients with good oral hygiene 6. Patients free from untreated periodontal disease
Who cannot join
- 1. Smokers 2. Psychological problem 3. Pregnancy 4. Systemic disease 5. Poor oral hygiene 6. Patients who previously received radiation therapy of the jaws 7. Patients taking medications that affect healing.
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
The British University in Egypt
Cairo, Cairo Governorate, 11837
Rania Hesham Shalaby, Demonstrator, 01091000217, rania.hesham@bue.edu.eg
Rania Hesham Shalaby, BDs
About this study
A stable soft and hard tissues around Osseo-integrated implants are very crucial. Soft tissue thickness around implants is crucial as it prevents peri-implant bone loss and enhance the esthetic outcomes. The treatment of thin tissue phenotype should be improved as the thin tissue phenotype will lead to plaque accumulation. There are some techniques that can increase the thickness of the peri-implant mucosa including connective tissue graft, platelet- rich fibrin and xenogeneic collagen matrix .Leukocyte and Platelet rich fibrin is a second generation platelet concentrate that was introduced by choukroun et al in 2001 after platelet rich plasma. PRF is the first source of autogenous blood derived growth factors harvested without the use of anticoagulants5. It contains various growth factors that are believed to contribute to periodontal regeneration. It promotes neovascularization and accelerated wound closing
Read the detailed description
Soft tissue thickness around implants is crucial as it prevents peri-implant bone loss and enhance the esthetic outcomes. The critical amount of soft tissue thickness on the buccal aspect of implants has been determined to be 2mm. Thick mucosal tissue often has better esthetic outcomes as it creates better tissue contour, mask the metal abutment and creating papilla after prosthesis fabrication. The difference in the amount of bone remodeling is related to the difference in mucosal tissue thickness, which is believed to be the result of supracrestal tissue height establishment. Presence of thin gingival phenotype around dental implant increases the prevalence of peri-implantitis and peri-implant mucositis. Thin gingival phenotype and inadequate keratinized mucosa width lead to greater food impaction compared with thick gingival phenotype and adequate keratinized mucosa. Patients with thin gingival phenotype have more pain and discomfort during oral hygiene therefore making it more difficult for plaque control.
Various techniques are used to increase the thickness of the peri-implant mucosa. These include connective tissue grafts, platelet-rich fibrin and xenogeneic collagen matrix. The volume of labial bone may be maintained by the increased thickness of soft tissue as a result of connective tissue graft . The autologous connective tissue graft has been widely recommended for mucosal tissue thickness enhancement due to its favorable thickness with minimal shrinkage in long-term follow-up when compared to other soft tissue graft approaches. Connective tissue graft (CTG) is considered the gold standard for soft-tissue correction and augmentation surgeries, but involves a secondary donor area and its associated complications. Connective tissue graft (CTG) has become a reliable treatment modality for increasing gingival thickness, width of keratinized gingiva, root coverage, treatment of furcation alveolar ridge deficiencies management of peri-implant tissue abnormalities and papillary loss. The scope of free gingival graft has been narrowed down especially in the esthetic region.
Leukocyte and Platelet rich fibrin is a second generation platelet concentrate that was introduced by choukroun et al in 2001 after platelet rich plasma. PRF is the first source of autogenous blood derived growth factors harvested without the use of anticoagulants. It is obtained by a simple and inexpensive procedure that does not require biochemical blood handling. Platelet-rich fibrin (PRF) is increasingly becoming popular in dentistry due to its growth factor-secreting properties and is also known to enhance wound healing and soft tissue thickness at the surgical site.
- Being tested
- Connective tissue graft(CTG), Connective tissue graft (CTG) + leukocyte platelet-rich fibrin (L-PRF)
- Keywords
- CTG, L-Prf, Soft tissue thickness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Connective tissue graft(CTG)Procedure or surgery
A harvested connective tissue graft will be placed in the prepared muco-periosteal flap around the implant. The graft will be adapted and secured in place using horizontal matrices.
Connective tissue graft (CTG) + leukocyte platelet-rich fibrin (L-PRF)Procedure or surgery
To prepare the L-PRF, a 10 ml of blood will be drawn from the antecubital vein of the patient's right or left arm and will be transferred to the free anticoagulant test-tube. The blood sample will be immediately centrifuged at 2700 rpm for 12 minutes33. L-PRF will be applied over the connective tissue graft in the prepared mucoperiosteal flap around the implant34. Then the graft will be secured with horizontal mattresses with an absorbable vicryl 6-0. A non-absorbable prolene suture will be used to approximate the flap.
| Study group | Role | What they receive |
|---|---|---|
| Control group | Other | Connective tissue graft (CTG) Receives: Procedure: Connective tissue graft(CTG) |
| Test group | Active comparator | Connective tissue graft (CTG) + leukocyte platelet-rich fibrin (L-PRF) Receives: Procedure: Connective tissue graft (CTG) + leukocyte platelet-rich fibrin (L-PRF) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Gingival thickness
Anesthetic needle with a rubber stopper36 Numerical (mm)
Measured: 6 months
Secondary outcomes (2)
Postoperative pain (direct)
Visual analogue scale.
Measured: 14 days
Width of keratinized mucosa
Graduated periodontal probe
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jan 2026
- Study start16 Jan 2026
- Primary completion31 Jul 2026 (estimated)
- Study completion31 Jul 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Soft Tissue Thickness Around Delayed Implants in Patients With Thin Gingival PhenotypeStudies 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
- 38 participants (estimated)
Sponsor and investigators
- Lead sponsor
- British University In Egypt
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rania hesham, British University In Egypt
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07368621
- Sponsor's protocol ID
- 23-051
- Status last verified
- Jan 2026
- First submitted
- 20 Jan 2026
- Last updated
- 26 Jan 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 26 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Connective Tissue Graft With and Without Leukocyte Platelet Rich Fibrin on Peri-implant Soft Tissue Thickness Around Delayed Implants in Patients With Thin Gingival Phenotype: A Randomized Controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT07368621
- Acronym / sponsor ID
- 23-051
- Keywords
- CTG, L-Prf, Soft tissue thickness
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 38 participants (estimated)
- Lead sponsor
- British University In EgyptUniversity, hospital or other
- Study start
- 16 Jan 2026 (actual)
- Primary completion
- 31 Jul 2026 (estimated)
- Study completion
- 31 Jul 2026 (estimated)
- First posted
- 26 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.
A stable soft and hard tissues around Osseo-integrated implants are very crucial. Soft tissue thickness around implants is crucial as it prevents peri-implant bone loss and enhance the esthetic outcomes. The treatment of thin tissue phenotype should be improved as the thin tissue phenotype will lead to plaque accumulation. There are some techniques that can increase the thickness of the peri-implant mucosa including connective tissue graft, platelet- rich fibrin and xenogeneic collagen matrix .Leukocyte and Platelet rich fibrin is a second generation platelet concentrate that was introduced by choukroun et al in 2001 after platelet rich plasma. PRF is the first source of autogenous blood derived growth factors harvested without the use of anticoagulants5. It contains various growth factors that are believed to contribute to periodontal regeneration. It promotes neovascularization and accelerated wound closing
Detailed description
Soft tissue thickness around implants is crucial as it prevents peri-implant bone loss and enhance the esthetic outcomes. The critical amount of soft tissue thickness on the buccal aspect of implants has been determined to be 2mm. Thick mucosal tissue often has better esthetic outcomes as it creates better tissue contour, mask the metal abutment and creating papilla after prosthesis fabrication. The difference in the amount of bone remodeling is related to the difference in mucosal tissue thickness, which is believed to be the result of supracrestal tissue height establishment. Presence of thin gingival phenotype around dental implant increases the prevalence of peri-implantitis and peri-implant mucositis. Thin gingival phenotype and inadequate keratinized mucosa width lead to greater food impaction compared with thick gingival phenotype and adequate keratinized mucosa. Patients with thin gingival phenotype have more pain and discomfort during oral hygiene therefore making it more difficult for plaque control.
Various techniques are used to increase the thickness of the peri-implant mucosa. These include connective tissue grafts, platelet-rich fibrin and xenogeneic collagen matrix. The volume of labial bone may be maintained by the increased thickness of soft tissue as a result of connective tissue graft . The autologous connective tissue graft has been widely recommended for mucosal tissue thickness enhancement due to its favorable thickness with minimal shrinkage in long-term follow-up when compared to other soft tissue graft approaches. Connective tissue graft (CTG) is considered the gold standard for soft-tissue correction and augmentation surgeries, but involves a secondary donor area and its associated complications. Connective tissue graft (CTG) has become a reliable treatment modality for increasing gingival thickness, width of keratinized gingiva, root coverage, treatment of furcation alveolar ridge deficiencies management of peri-implant tissue abnormalities and papillary loss. The scope of free gingival graft has been narrowed down especially in the esthetic region.
Leukocyte and Platelet rich fibrin is a second generation platelet concentrate that was introduced by choukroun et al in 2001 after platelet rich plasma. PRF is the first source of autogenous blood derived growth factors harvested without the use of anticoagulants. It is obtained by a simple and inexpensive procedure that does not require biochemical blood handling. Platelet-rich fibrin (PRF) is increasingly becoming popular in dentistry due to its growth factor-secreting properties and is also known to enhance wound healing and soft tissue thickness at the surgical site.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control group | Other | Procedure: Connective tissue graft(CTG)Connective tissue graft (CTG) |
| Test group | Active comparator | Procedure: Connective tissue graft (CTG) + leukocyte platelet-rich fibrin (L-PRF)Connective tissue graft (CTG) + leukocyte platelet-rich fibrin (L-PRF) |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- 1. Patients between 18-60 years. 2. With thin gingival phenotype with a peri-implant mucosal thickness of less than 2mm28. With single missing tooth in the incisor, canine and premolar area. With the presence of two natural adjacent teeth and to not have a bone augmentation procedure before or during the dental implant.
- 3. Patient consent approval and signing 4. Medically free patients 5. Patients with good oral hygiene 6. Patients free from untreated periodontal disease
Key exclusion criteria (1 listed)
- 1. Smokers 2. Psychological problem 3. Pregnancy 4. Systemic disease 5. Poor oral hygiene 6. Patients who previously received radiation therapy of the jaws 7. Patients taking medications that affect healing.
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 |
|---|---|---|
| Connective tissue graft(CTG)A harvested connective tissue graft will be placed in the prepared muco-periosteal flap around the implant. The graft will be adapted and secured in place using horizontal matrices. | Procedure or surgery | Control group |
| Connective tissue graft (CTG) + leukocyte platelet-rich fibrin (L-PRF)To prepare the L-PRF, a 10 ml of blood will be drawn from the antecubital vein of the patient's right or left arm and will be transferred to the free anticoagulant test-tube. The blood sample will be immediately centrifuged at 2700 rpm for 12 minutes33. L-PRF will be applied over the connective tissue graft in the prepared mucoperiosteal flap around the implant34. Then the graft will be secured with horizontal mattresses with an absorbable vicryl 6-0. A non-absorbable prolene suture will be used to approximate the flap. | Procedure or surgery | Test group |
Primary outcome
Gingival thickness
Time frame: 6 months
Anesthetic needle with a rubber stopper36 Numerical (mm)
2 secondary outcomes
Postoperative pain (direct)
Time frame: 14 days
Width of keratinized mucosa
Time frame: 6 months
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 26 Jan 2026.
- Individual participant dataSharing planned: Undecided
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 Connective tissue graft(CTG) and Connective tissue graft (CTG) + leukocyte platelet-rich fibrin (L-PRF) in people with Soft Tissue Thickness Around Delayed Implants in Patients With Thin Gingival Phenotype, run by British 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 2 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 26 Jan 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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Gingival thickness (time frame: 6 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 26 Jan 2026.