Dental Implant FailedNCT07596758
Immediate Implant Placement With Subepithelial Connective Tissue Grafting and Probiotics
A study testing Platelet-Rich Fibrin and Probiotics in people with Dental Implant Failed, run by Kafrelsheikh University at 1 site in Egypt.
Trial summary
The present study aims to evaluate and compare the clinical, radiographic, and biological peri-implant tissue outcomes of platelet-rich fibrin versus probiotics as adjuncts to immediate implant placement combined with subepithelial connective tissue grafting in adults requiring single immediate implant placement. Read more about this study
- Who is it for?
- Ages 20 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Dental Implant Failed
- What is being tested?
- Platelet-Rich Fibrin and Probiotics
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 22 participants
- Where
- 1 siteEgypt
- Study dates
- 14 May 2026to 30 May 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 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Adults aged 20 to 45 years.
- Systemically healthy patients eligible for implant surgery.
- Patients requiring extraction of a single non-restorable tooth indicated for immediate implant placement.
- Implant sites located in the maxillary esthetic or para-esthetic zone.
- Sites with sufficient apical and/or palatal bone to permit correct three-dimensional implant positioning and achieve adequate primary stability.
- Sites suitable for simultaneous subepithelial connective tissue grafting.
- Patients with acceptable oral hygiene and good compliance with periodontal and implant treatment.
- Patients willing to attend all follow-up visits and comply with study instructions.
Who cannot join
- Medically compromised patients or patients with systemic conditions that may contraindicate implant surgery or interfere with healing.
- Smokers.
- Pregnant or lactating women.
- Patients with uncontrolled periodontal disease or poor oral hygiene.
- Patients with acute infection at the intended implant site.
- Patients with insufficient bone volume preventing immediate implant placement with adequate primary stability.
Show all 10Show fewer
- Patients with a history of head and neck radiotherapy or chemotherapy.
- Patients receiving bisphosphonates or other medications known to affect bone metabolism or soft tissue healing.
- Patients with parafunctional habits that may jeopardize implant stability or restorative success.
- Patients unwilling or unable to complete the follow-up period.
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
faculty of dentistry, kafrelsheikh University
Kafr ash Shaykh, Kafrelsheikh, 214312
About this study
Official title: Comparative Evaluation of Platelet-Rich Fibrin Versus Probiotics as Adjuncts to Immediate Implant Placement Combined With Subepithelial Connective Tissue Grafting: Clinical, Biological, and Radiographic Peri-Implant Tissue Outcomes A Parallel-Arm Randomized Trial
The present study aims to evaluate and compare the clinical, radiographic, and biological peri-implant tissue outcomes of platelet-rich fibrin versus probiotics as adjuncts to immediate implant placement combined with subepithelial connective tissue grafting in adults requiring single immediate implant placement.
Read the detailed description
Dental implant therapy in the esthetic zone is currently judged not only by implant survival but also by preservation of peri-implant hard and soft tissues, maintenance of facial mucosal stability, and achievement of acceptable esthetic outcomes. Immediate implant placement is attractive because it may shorten treatment time, reduce the number of surgical procedures, and preserve the restorative pathway. Nevertheless, immediate placement does not eliminate the physiologic remodeling that follows tooth extraction, particularly at the facial aspect of the socket. Recent evidence has shown that even when immediate implants are successfully integrated, post-extraction dimensional changes may still compromise mucosal contour, midfacial level, and long-term esthetic integration.
Because implant timing alone cannot fully prevent hard- and soft-tissue alteration, contemporary immediate implant therapy increasingly incorporates peri-implant tissue augmentation procedures. Among these, peri-implant soft-tissue augmentation has become an important component of treatment planning because it may improve tissue volume, phenotype, and esthetic stability. Current evidence also indicates that autogenous grafts generally provide more favorable peri-implant soft-tissue augmentation outcomes than substitute materials. In parallel, adequate keratinized mucosa continues to be associated with better peri-implant clinical conditions and lower risk of peri-implant disease, highlighting the importance of peri-implant soft-tissue quality as both an esthetic and biologic determinant of treatment success. Additional systematic evidence has further supported the positive relationship between keratinized mucosa and peri-implant health and stability.
Within this context, subepithelial connective tissue grafting has become a key strategy for enhancing peri-implant mucosal thickness and supporting facial mucosal stability around immediate implants. Randomized clinical evidence has shown that connective tissue grafting performed with single immediate implants in the maxillary esthetic zone can improve mid-buccal mucosal stability over long-term follow-up. Other randomized data have also demonstrated favorable esthetic and peri-implant tissue outcomes when soft-tissue grafting is incorporated into immediate implant protocols. More recent volumetric clinical findings have reinforced the importance of peri-implant soft-tissue volume in limiting unfavorable midfacial mucosal alterations after immediate implant placement.
Although subepithelial connective tissue grafting is an established soft-tissue approach, interest has grown in adjunctive biologic interventions that may further enhance wound healing and peri-implant tissue maturation. Platelet-rich fibrin has received considerable attention because it is an autologous fibrin matrix rich in platelets, leukocytes, and growth factors that may promote angiogenesis, fibroblast proliferation, soft-tissue healing, and early tissue remodeling. Recent clinical evidence has shown that leukocyte-platelet-rich fibrin may improve peri-implant mucosal dimensions and soft-tissue enhancement around implants. In addition, systematic review and meta-analytic evidence suggest that injectable platelet-rich fibrin can positively influence gingival phenotype modification, supporting its biologic plausibility as an adjunctive soft-tissue enhancer.
At the same time, probiotics have emerged as a potentially valuable adjunct in implant dentistry because of their capacity to regulate the oral microbiome, modulate inflammatory pathways, and influence host immune balance. Recent evidence has suggested that probiotics may promote bone homeostasis, facilitate tissue regeneration, and reduce peri-implant inflammatory burden through control of dysbiosis and host modulation. Systematic review evidence in peri-implant oral diseases has shown that probiotic therapy may improve certain clinical and inflammatory parameters, although the available data remain heterogeneous and not yet definitive. More recent meta-analytic findings have similarly indicated that probiotics may provide adjunctive benefits in peri-implant disease management, while also confirming the need for further well-designed trials.
Beyond clinical and esthetic evaluation, biologic monitoring has become increasingly important in peri-implant research. Peri-implant crevicular fluid biomarkers may provide insight into inflammatory activity and tissue remodeling before overt clinical breakdown becomes evident. Among these biomarkers, matrix metalloproteinase-8 has attracted particular attention because it is closely associated with collagen degradation and peri-implant inflammatory activity, making it one of the most relevant biologic markers for assessing peri-implant tissue breakdown.
Despite the expanding literature on immediate implant placement, peri-implant soft-tissue grafting, platelet-rich fibrin, probiotics, and biomarker-based peri-implant assessment, there is still no clear randomized clinical evidence directly comparing platelet-rich fibrin and probiotics as adjuncts to immediate implant placement combined with subepithelial connective tissue grafting. Therefore, the rationale of the present study is to evaluate whether these two biologically distinct adjunctive approaches differ in their clinical, radiographic, and biologic effects on peri-implant tissue outcomes, thereby helping to optimize peri-implant tissue management in immediate implant therapy.
- Conditions
- Dental Implant Failed
- Being tested
- Platelet-Rich Fibrin, Probiotics
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Platelet-Rich FibrinProcedure or surgery
platelet-rich fibrin will be prepared immediately before application using freshly drawn autologous venous blood and a standardized centrifugation protocol selected according to the equipment available in the study setting. The prepared PRF will be used as an adjunct to the immediate implant and subepithelial connective tissue grafting procedure according to the finalized protocol, either locally around the peri-implant site and/or in intimate relation to the grafted soft tissue to enhance healing and tissue maturation.
ProbioticsProcedure or surgery
Probiotics probiotics will be administered as an adjunct to the immediate implant and subepithelial connective tissue grafting The mode of delivery, dose, and duration will be standardized for all patients allocated to this group.
| Study group | Role | What they receive |
|---|---|---|
| platelet-rich fibrin group | Experimental | Immediate implant placement with subepithelial connective tissue grafting and adjunctive platelet-rich fibrin Receives: Procedure: Platelet-Rich Fibrin |
| probiotics group | Experimental | Immediate implant placement with subepithelial connective tissue grafting and adjunctive probiotics Receives: Procedure: Probiotics |
What is being measured
The primary outcome is the main question the study is designed to answer.
evaluation of matrix metalloproteinase-8 (MMP-8) levels
Biological assessment will be performed by collecting peri-implant sulcular fluid samples for evaluation of matrix metalloproteinase-8 (MMP-8) levels.
After gentle removal of supragingival plaque, the peri-implant site will be isolated with cotton rolls and dried with mild air flow. Sterile PerioPaper strips will be inserted carefully into the peri-implant sulcus until slight resistance is encountered and left in place for 30 seconds. Any strip contaminated with blood or saliva will be discarded. The collected samples will be transferred to sterile Eppendorf tubes and stored until analysis.
Quantitative assessment of MMP-8 will be carried out using a human MMP-8 ELISA kit according to the manufacturer's protocol.
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 posted19 May 2026
- Study start14 May 2026 (estimated)
- Primary completion20 May 2027 (estimated)
- Study completion30 May 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dental Implant FailedStudies of the same condition, open and under way.
- More trials run by Kafrelsheikh UniversityThe sponsor's other registered studies.
- 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
- Model description
- two parallel-arm randomized controlled clinical trial with allocation concealment
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 22 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Kafrelsheikh University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Walid Elamrousy, Kafrelsheikh University
- Investigators
- walid elamrousy, phd, Principal investigator, Kafrelsheikh University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07596758
- Sponsor's protocol ID
- KFSIRB200-1008
- Status last verified
- May 2026
- First submitted
- 13 May 2026
- Last updated
- 19 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: upon request
Study at a glance
From the registry record, last updated by the sponsor on 19 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Evaluation of Platelet-Rich Fibrin Versus Probiotics as Adjuncts to Immediate Implant Placement Combined With Subepithelial Connective Tissue Grafting: Clinical, Biological, and Radiographic Peri-Implant Tissue Outcomes A Parallel-Arm Randomized Trial
- ClinicalTrials.gov ID
- NCT07596758
- Acronym / sponsor ID
- KFSIRB200-1008
- Conditions
- Dental Implant Failed
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 22 participants (estimated)
- Lead sponsor
- Kafrelsheikh UniversityUniversity, hospital or other
- Study start
- 14 May 2026 (estimated)
- Primary completion
- 20 May 2027 (estimated)
- Study completion
- 30 May 2027 (estimated)
- First posted
- 19 May 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 present study aims to evaluate and compare the clinical, radiographic, and biological peri-implant tissue outcomes of platelet-rich fibrin versus probiotics as adjuncts to immediate implant placement combined with subepithelial connective tissue grafting in adults requiring single immediate implant placement.
Detailed description
Dental implant therapy in the esthetic zone is currently judged not only by implant survival but also by preservation of peri-implant hard and soft tissues, maintenance of facial mucosal stability, and achievement of acceptable esthetic outcomes. Immediate implant placement is attractive because it may shorten treatment time, reduce the number of surgical procedures, and preserve the restorative pathway. Nevertheless, immediate placement does not eliminate the physiologic remodeling that follows tooth extraction, particularly at the facial aspect of the socket. Recent evidence has shown that even when immediate implants are successfully integrated, post-extraction dimensional changes may still compromise mucosal contour, midfacial level, and long-term esthetic integration.
Because implant timing alone cannot fully prevent hard- and soft-tissue alteration, contemporary immediate implant therapy increasingly incorporates peri-implant tissue augmentation procedures. Among these, peri-implant soft-tissue augmentation has become an important component of treatment planning because it may improve tissue volume, phenotype, and esthetic stability. Current evidence also indicates that autogenous grafts generally provide more favorable peri-implant soft-tissue augmentation outcomes than substitute materials. In parallel, adequate keratinized mucosa continues to be associated with better peri-implant clinical conditions and lower risk of peri-implant disease, highlighting the importance of peri-implant soft-tissue quality as both an esthetic and biologic determinant of treatment success. Additional systematic evidence has further supported the positive relationship between keratinized mucosa and peri-implant health and stability.
Within this context, subepithelial connective tissue grafting has become a key strategy for enhancing peri-implant mucosal thickness and supporting facial mucosal stability around immediate implants. Randomized clinical evidence has shown that connective tissue grafting performed with single immediate implants in the maxillary esthetic zone can improve mid-buccal mucosal stability over long-term follow-up. Other randomized data have also demonstrated favorable esthetic and peri-implant tissue outcomes when soft-tissue grafting is incorporated into immediate implant protocols. More recent volumetric clinical findings have reinforced the importance of peri-implant soft-tissue volume in limiting unfavorable midfacial mucosal alterations after immediate implant placement.
Although subepithelial connective tissue grafting is an established soft-tissue approach, interest has grown in adjunctive biologic interventions that may further enhance wound healing and peri-implant tissue maturation. Platelet-rich fibrin has received considerable attention because it is an autologous fibrin matrix rich in platelets, leukocytes, and growth factors that may promote angiogenesis, fibroblast proliferation, soft-tissue healing, and early tissue remodeling. Recent clinical evidence has shown that leukocyte-platelet-rich fibrin may improve peri-implant mucosal dimensions and soft-tissue enhancement around implants. In addition, systematic review and meta-analytic evidence suggest that injectable platelet-rich fibrin can positively influence gingival phenotype modification, supporting its biologic plausibility as an adjunctive soft-tissue enhancer.
At the same time, probiotics have emerged as a potentially valuable adjunct in implant dentistry because of their capacity to regulate the oral microbiome, modulate inflammatory pathways, and influence host immune balance. Recent evidence has suggested that probiotics may promote bone homeostasis, facilitate tissue regeneration, and reduce peri-implant inflammatory burden through control of dysbiosis and host modulation. Systematic review evidence in peri-implant oral diseases has shown that probiotic therapy may improve certain clinical and inflammatory parameters, although the available data remain heterogeneous and not yet definitive. More recent meta-analytic findings have similarly indicated that probiotics may provide adjunctive benefits in peri-implant disease management, while also confirming the need for further well-designed trials.
Beyond clinical and esthetic evaluation, biologic monitoring has become increasingly important in peri-implant research. Peri-implant crevicular fluid biomarkers may provide insight into inflammatory activity and tissue remodeling before overt clinical breakdown becomes evident. Among these biomarkers, matrix metalloproteinase-8 has attracted particular attention because it is closely associated with collagen degradation and peri-implant inflammatory activity, making it one of the most relevant biologic markers for assessing peri-implant tissue breakdown.
Despite the expanding literature on immediate implant placement, peri-implant soft-tissue grafting, platelet-rich fibrin, probiotics, and biomarker-based peri-implant assessment, there is still no clear randomized clinical evidence directly comparing platelet-rich fibrin and probiotics as adjuncts to immediate implant placement combined with subepithelial connective tissue grafting. Therefore, the rationale of the present study is to evaluate whether these two biologically distinct adjunctive approaches differ in their clinical, radiographic, and biologic effects on peri-implant tissue outcomes, thereby helping to optimize peri-implant tissue management in immediate implant therapy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- two parallel-arm randomized controlled clinical trial with allocation concealment
| Arm | Type | Receives |
|---|---|---|
| platelet-rich fibrin group | Experimental | Procedure: Platelet-Rich FibrinImmediate implant placement with subepithelial connective tissue grafting and adjunctive platelet-rich fibrin |
| probiotics group | Experimental | Procedure: ProbioticsImmediate implant placement with subepithelial connective tissue grafting and adjunctive probiotics |
Who may qualify
- Ages
- 20 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- Adults aged 20 to 45 years.
- Systemically healthy patients eligible for implant surgery.
- Patients requiring extraction of a single non-restorable tooth indicated for immediate implant placement.
- Implant sites located in the maxillary esthetic or para-esthetic zone.
- Sites with sufficient apical and/or palatal bone to permit correct three-dimensional implant positioning and achieve adequate primary stability.
Key exclusion criteria (10 listed)
- Medically compromised patients or patients with systemic conditions that may contraindicate implant surgery or interfere with healing.
- Smokers.
- Pregnant or lactating women.
- Patients with uncontrolled periodontal disease or poor oral hygiene.
- Patients with acute infection at the intended implant site.
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 |
|---|---|---|
| Platelet-Rich Fibrinplatelet-rich fibrin will be prepared immediately before application using freshly drawn autologous venous blood and a standardized centrifugation protocol selected according to the equipment available in the study setting. The prepared PRF will be used as an adjunct to the immediate implant and subepithelial connective tissue grafting procedure according to the finalized protocol, either locally around the peri-implant site and/or in intimate relation to the grafted soft tissue to enhance healing and tissue maturation. | Procedure or surgery | platelet-rich fibrin group |
| ProbioticsProbiotics probiotics will be administered as an adjunct to the immediate implant and subepithelial connective tissue grafting The mode of delivery, dose, and duration will be standardized for all patients allocated to this group. | Procedure or surgery | probiotics group |
Primary outcome
evaluation of matrix metalloproteinase-8 (MMP-8) levels
Time frame: 12-months
Biological assessment will be performed by collecting peri-implant sulcular fluid samples for evaluation of matrix metalloproteinase-8 (MMP-8) levels. After gentle removal of supragingival plaque, the peri-implant site will be isolated with cotton rolls and dried with mild air flow. Sterile PerioPaper strips will be inserted carefully into the peri-implant sulcus until slight resistance is encountered and left in place for 30 seconds. Any strip contaminated with blood or saliva will be discarded. The collected samples will be transferred to sterile Eppendorf tubes and stored until analysis. Quantitative assessment of MMP-8 will be carried out using a human MMP-8 ELISA kit according to the manufacturer's protocol.
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 19 May 2026.
- Individual participant dataSharing planned: Yes. upon request
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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.
walid elamrousy, phd principal investigator
Kafrelsheikh University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Platelet-Rich Fibrin and Probiotics in people with Dental Implant Failed, run by Kafrelsheikh 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 8 inclusion and 10 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: opening soon, as of the sponsor's last update on 19 May 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 walid elamrousy, Phd (01029552024, waled_hammed@den.kfs.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
evaluation of matrix metalloproteinase-8 (MMP-8) levels (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 19 May 2026.