Recession, GingivalNCT07102758
L-PRF vs Connective Tissue With Customized Healing Abutment in Immediate Implant Placement
A study testing L-PRF with dental implant and customized healing abutment and Connective tissue with dental implant and customized healing abutment in people with Recession, Gingival and Bone Loss in Jaw, run by Kafrelsheikh University at 1 site in Egypt.
Trial summary
comparison between L-prf and connective tissue with dental implant Read more about this study
- Who is it for?
- Ages 21 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Recession, Gingival, Bone Loss in Jaw
- What is being tested?
- L-PRF with dental implant and customized healing abutment and Connective tissue with dental implant and customized healing abutment
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 1 siteEgypt
- Study dates
- 5 Aug 2025to 20 Aug 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 21 to 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Intact labial/buccal bone plate
- The presence of non-restorable single-rooted maxillary centrals, canines or premolars.
- Sufficient bone volume.
- Good oral hygiene.
- Nonsmokers.
- Sufficient bone width (≥ 1 mm) in the buccal plate of the remaining bone to place an implant confirmed by cone beam computer tomography (CBCT).
Who cannot join
- Insufficient bone volume.
- Active infection.
- Patients on chemotherapy or radiotherapy.
- Patients who have systemic disorders {uncontrolled diabetes mellitus, autoimmune disease, …etc},
- Pregnant patients,
- Patients with bone diseases
- Presence of periapical pathology.
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
Kafrelsheikh University
Kafr ash Shaykh, Kafrelsheikh
Enas Ahmed Elgendy, Dean of Faculty of Dentistry, 0201003508797, enas_ahmed@den.kfs.edu
Enas Ahmed Elgendy, Dean of Faculty of Dentistry
About this study
Official title: Evaluation of Soft and Hard Tissue Augmentation by Connective Tissue Graft or Leukocyte-Platelet Rich Fibrin in Immediate Implant Placement With Customized Healing Abutment: A Randomized Controlled Clinical Trial.
comparison between L-prf and connective tissue with dental implant
Read the detailed description
comparison between L-PRF and Connective tissue with customized healing abutment regaring soft and hard tissue outcomes with immediate dental implants.
- Conditions
- Recession, Gingival, Bone Loss in Jaw
- Being tested
- L-PRF with dental implant and customized healing abutment, Connective tissue with dental implant and customized healing abutment
- Keywords
- L-prf, connective tissue, customized healing abutment, implant
- Medical subject headings
- Gingival Recession
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
L-PRF with dental implant and customized healing abutmentProcedure or surgery
L-PRF with dental implant and customized healing abutment
Connective tissue with dental implant and customized healing abutmentProcedure or surgery
Connective tissue with dental implant and customized healing abutment
| Study group | Role | What they receive |
|---|---|---|
| Connective tissue with dental implant and customized healing abutment | Active comparator | Connective tissue with dental implant and customized healing abutment Receives: Procedure: Connective tissue with dental implant and customized healing abutment |
| L-PRF with dental implant and customized healing abutment | Experimental | L-PRF with dental implant and customized healing abutment Receives: Procedure: L-PRF with dental implant and customized healing abutment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient-reported pain experience
Pain experience after surgery is daily measured by the patients using a visual analogue scale (VAS) in the first postoperative 7 days, with Day 0 being the day of the surgery. Before going to sleep, patients will be asked to mark the VAS that best represented the average pain they had experienced during the day.
Measured: first 7 days after surgery
Pink aesthetic score
Parameters are : 0,1 and 2.
Mesial papilla : 0 ( Missing ) , 1 ( Incomplete ) and 2 ( Complete ).
Distal Papilla : 0 ( Missing ) , 1 ( Incomplete ) and 2 ( Complete ).
Tissue contour : 0 ( Unnatural) , 1 ( virtually natural ) and 2 ( natural).
Gingival level : 0 ( >2mm) , 1 ( 1-2mm ) and 2 ( 1 mm).
Alveolar process : 0 ( clearly resorbed ) , 1 ( slightly resorbed ) and 2 ( no difference).
Coloring : 0 ( clear difference ) , 1 ( slight difference ) and 2 ( no difference).
Texture : 0 ( clear difference ) , 1 ( slight difference ) and 2 ( no difference).
Measured: before surgery, 3 months and 6 months after surgery
crestal bone loss
distance from implant shoulder to marginal bone
Measured: preoperative and 6 months post operative
Secondary outcomes (3)
Gingival thickness
1 mm apical to gingival margin in mid buccal
Measured: pre opearative, 3 and 6 months post operative
probing pocket depth
mid buccal , mesio buccal , disto buccal and mid palatal
Measured: preoperative , 3 and 6 months post operative
keratinized tissue width
in mid buccal, from gingival margin to mucogingival junction
Measured: preoperative , 3 and 6 months post operative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Aug 2025
- Study start5 Aug 2025 (estimated)
- Primary completion10 Aug 2026 (estimated)
- Study completion20 Aug 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Recession, GingivalStudies 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
- 16 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Kafrelsheikh University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahmed Atef Salem, Kafrelsheikh University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07102758
- Sponsor's protocol ID
- KFSIRB200-436
- Status last verified
- Aug 2025
- First submitted
- 30 Jul 2025
- Last updated
- 14 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Soft and Hard Tissue Augmentation by Connective Tissue Graft or Leukocyte-Platelet Rich Fibrin in Immediate Implant Placement With Customized Healing Abutment: A Randomized Controlled Clinical Trial.
- ClinicalTrials.gov ID
- NCT07102758
- Acronym / sponsor ID
- KFSIRB200-436
- Conditions
- Recession, Gingival, Bone Loss in Jaw
- Keywords
- L-prf, connective tissue, customized healing abutment, implant
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 16 participants (estimated)
- Lead sponsor
- Kafrelsheikh UniversityUniversity, hospital or other
- Study start
- 5 Aug 2025 (estimated)
- Primary completion
- 10 Aug 2026 (estimated)
- Study completion
- 20 Aug 2027 (estimated)
- First posted
- 5 Aug 2025 (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.
comparison between L-prf and connective tissue with dental implant
Detailed description
comparison between L-PRF and Connective tissue with customized healing abutment regaring soft and hard tissue outcomes with immediate dental implants.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Connective tissue with dental implant and customized healing abutment | Active comparator | Procedure: Connective tissue with dental implant and customized healing abutmentConnective tissue with dental implant and customized healing abutment |
| L-PRF with dental implant and customized healing abutment | Experimental | Procedure: L-PRF with dental implant and customized healing abutmentL-PRF with dental implant and customized healing abutment |
Who may qualify
- Ages
- 21 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Intact labial/buccal bone plate
- The presence of non-restorable single-rooted maxillary centrals, canines or premolars.
- Sufficient bone volume.
- Good oral hygiene.
- Nonsmokers.
Key exclusion criteria (7 listed)
- Insufficient bone volume.
- Active infection.
- Patients on chemotherapy or radiotherapy.
- Patients who have systemic disorders {uncontrolled diabetes mellitus, autoimmune disease, …etc},
- Pregnant patients,
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 |
|---|---|---|
| L-PRF with dental implant and customized healing abutmentL-PRF with dental implant and customized healing abutment | Procedure or surgery | L-PRF with dental implant and customized healing abutment |
| Connective tissue with dental implant and customized healing abutmentConnective tissue with dental implant and customized healing abutment | Procedure or surgery | Connective tissue with dental implant and customized healing abutment |
Primary outcome
Patient-reported pain experience
Time frame: first 7 days after surgery
Pain experience after surgery is daily measured by the patients using a visual analogue scale (VAS) in the first postoperative 7 days, with Day 0 being the day of the surgery. Before going to sleep, patients will be asked to mark the VAS that best represented the average pain they had experienced during the day.
Pink aesthetic score
Time frame: before surgery, 3 months and 6 months after surgery
Parameters are : 0,1 and 2. Mesial papilla : 0 ( Missing ) , 1 ( Incomplete ) and 2 ( Complete ). Distal Papilla : 0 ( Missing ) , 1 ( Incomplete ) and 2 ( Complete ). Tissue contour : 0 ( Unnatural) , 1 ( virtually natural ) and 2 ( natural). Gingival level : 0 ( >2mm) , 1 ( 1-2mm ) and 2 ( 1 mm). Alveolar process : 0 ( clearly resorbed ) , 1 ( slightly resorbed ) and 2 ( no difference). Coloring : 0 ( clear difference ) , 1 ( slight difference ) and 2 ( no difference). Texture : 0 ( clear difference ) , 1 ( slight difference ) and 2 ( no difference).
crestal bone loss
Time frame: preoperative and 6 months post operative
distance from implant shoulder to marginal bone
3 secondary outcomes
Gingival thickness
Time frame: pre opearative, 3 and 6 months post operative
probing pocket depth
Time frame: preoperative , 3 and 6 months post operative
keratinized tissue width
Time frame: preoperative , 3 and 6 months post operative
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 14 Aug 2025.
Related trials for Recession, Gingival
Recruiting
Palatal Wound Healing After Free Gingival Graft Harvest in Diabetic Patients: A Clinical Trial
Diabetes Mellitus, Gingival Recession, Generalized
Not yet recruiting
Evaluation of the Effect of Smoking on Palatal Donor Site Tissue Profile in the Success of Connective Tissue Grafts
Soft Tissue Augmentation, Gingival Recession Localized Moderate
Active, not recruiting
Vertically Coronally Advanced Flap Versus Coronally Advanced Flap for Miller Class I Gingival Recession
Gingival Recession
Recruiting
Effects of Low-Level Laser Therapy and Hyaluronic Acid After Free Gingival Graft
Gingival Recession, Mucogingival Surgery
Recruiting
Impact of Root Surface Conditioning With Erythritol Air Polishing and Hand Instrumentation on Recession Coverage Using the Modified Tunnel Technique and Subepithelial Connective Tissue Graft.
Gingival Recession
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 L-PRF with dental implant and customized healing abutment and Connective tissue with dental implant and customized healing abutment in people with Recession, Gingival and Bone Loss in Jaw, 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 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: looking for participants now, as of the sponsor's last update on 14 Aug 2025. 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 Ahmed Atef Salem, General doctor (0201007737797, dent.ahmedatef@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Patient-reported pain experience (time frame: first 7 days after surgery). The study lists 3 primary outcomes in all. 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 14 Aug 2025.