RecessionNCT04091802
Effect of Monolayer Versus Multilayer Leucocyte-Platelet Rich Fibrin (L-PRF) in Interdental Papillary Reconstruction
A study testing interdental papilla reconstruction with L-PRF in people with Recession, run by Ain Shams University.
Trial summary
The interdental papilla is very small but it has a great implication from an aesthetic view, more specifically in the anterior region because it is always displayed during smiling. Read more about this study
- Who is it for?
- Ages 18 to 40 years
- Conditions the study is for
- Recession
- What is being tested?
- interdental papilla reconstruction with L-PRF
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- No sites listed yet
- Study dates
- Jan 2016to Aug 2019
- 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 40 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 1. Patients diagnosed with black triangles. 2. Both genders aged from 18-40 years. 3. Patients should be systemically free. 4. Patients with Nordland's class I or II. Nordland and Tarnow classified the interdental papilla loss; the classification is based on three anatomic landmarks: the contact point interdentally, the coronal level of the CEJ interproximally and the facial apical level of the cemento-enamel junction (CEJ). [Nordland WP, et al, 1998] Four classes were identified
- Normal: The interdental papilla fills up the whole embrasure to the interproximal contact point.
- Class I: Presence of the tip of the papilla between interdental contact point and the interproximal CEJ.
- Class II: Presence of the tip of the papilla at the interproximal CEJ or apical to it but still coronal to the facial CEJ.
- Class III: Presence of the tip of papilla at similar plane with the labial CEJ or apical to it.
- 5. The vertical distance from the interdental contact point to the crest of the interdental bone is ≥ 6 mm as measured by bone sounding.
- 6. A band of keratinized tissue should be present around the test teeth ≥ 2 mm. 7. Gingival biotype of the area to be treated is ≥ 2 mm in thickness.
Who cannot join
- Acute periapical lesion.
- moderate to severe form of periodontitis.
- Pregnancy and lactation.
- parafunctional habits.
- Smoking, alcoholics or drug abusers.
- Teeth with interdental spacing, rotation or inclination or crowding.
- Vulnerable group of patients.
About this study
Official title: Effect of Monolayer Versus Multilayer Leucocyte-Platelet Rich Fibrin (L-PRF) in Interdental Papillary Reconstruction" (A Randomized Controlled Clinical Study)
The interdental papilla is very small but it has a great implication from an aesthetic view, more specifically in the anterior region because it is always displayed during smiling. The lack of interdental papilla due to periodontal disease or periodontal therapy leads to aesthetic problems with food stagnation as well as phonetic problem due to the space that allows passage of the air or saliva. Leukocyte-PRF (L-PRF) membrane was developed which includes the majority of the platelets in addition to half of the leukocytes so that lymphocytes as well as the platelet growth factors are trapped inside a fibrin network. Multiple layers of L-PRF may have observable effect on tissue regeneration because it increases the number of growth factors and acts as a strong scaffold which helps in creeping of the cells along it as it remains active and in place for more than 7 days. Thus, the aim of this study will be conducted to compare the effect of one layer versus multiple layers of L-PRF in interdental papillary reconstruction.
Read the detailed description
A total of 20 patients will be selected who are caring about esthetics and concerned to go through the management of eradication of "black triangles" by interdental papillae reconstruction in esthetic zone and systemically free with Nordland's class I or II and The vertical distance from the interdental contact point to the crest of the interdental bone is ≥ 6 mm as measured by bone sounding, A band of keratinized tissue should be present around the test teeth ≥ 2 mm, Gingival biotype of the area to be treated is ≥ 2 mm in thickness.
The study protocol will be explained in details to all patients. Then a signed informed consent will be obtained from the patients. The data obtained from patients as well as the results of the follow up will be kept confidential.
The study will be introduced to ethics' committee of Faculty of Dentistry Ain Shams University and has to be approved before the start of the study Eligible patients will be randomized in a 1:1 ratio into two groups; (Group I) included 10 patients and (Group II) included 10 patients. The computer-generated randomization assignment (blocks of 4) and allocation concealment will be performed by sealed envelopes containing the randomization number prepared by non involved member and sent to principle investigator to assign the interventions to patients Group I: 10 patients will undergo interdental papillary reconstruction using one layer of L-PRF.
Group II: 10 patients will receive interdental papillary reconstruction using multiple layers of L-PRF (Two or more according to the compressibility in which if ≥1mm, it needs one more layer, and if ≤1 mm, then no need to more than 2 layers; it cannot be standardized).
Procedure:
- All patients will receive Phase I therapy including oral hygiene measures and scaling and root planning whenever indicated.
- Preparation of recipient site: The preparation of the recipient site is similar to that described by Reddy.
- Anasthesia of the surgical field.
- A single vertical incision will be made in the buccal vestibule apical to the mucogingival junction in the mid interproximal area of the papilla to be treated.
- Intrasulcular releasing incisions will be made on the teeth adjacent to the papilla to be augmented and extend to the buccal and palatal aspects without altering the integrity of the papilla.
- The incisions will maintain the full height and thickness of the gingiva.
- Papilla will be undermined carefully to maintain integrity and a space will be created under the papilla by elevating it coronally.
- Preparation of L-PRF: L-PRF will be prepared according to Chaukroun's et al. 2001. Immediately prior to the surgery, 10 ml of blood (for each membrane) will be collected from the patient by venipuncture of antecubital vein and then drawn quickly into sterile glass tube with no anticoagulant and immediately centrifuged at 2700 rpm for 12 minutes at room temperature by using the Intra-Spin centrifuge (Intra-Lock). Then L-PRF clot will be removed by sterile tweezers and placed in Xpression™ kit for gentle compression by gravity. Then L-PRF will be ready to be used after 5 minutes (For group II, membranes will be sutured together before placement in the vertical incision).
- Placement and suturing of L-PRF in the recipient site: The L-PRF membrane will be trimmed to the desired shape and size and then placed under the papilla and mucogingival complex through the vertical incision to fill the black space. Then incision will be closed with 5-0 polypropylene simple interrupted sutures.
- Post operative management:
It will include pain control using anti-inflammatory and analgesics (Brufen 600 mg) when needed and twice mouth rinse with chlorohexidine gluconate daily for one week.
All Clinical and volumetric measurements will be carried out at baseline and after 6 months follow up and esthetic assessment will be done.
Clinical assessment will be Plaque score index (PI), gingival score index (GI), papillary height from the tip of the papilla to mesial line angle, Nordland and Tarnaw classification.
volumetric assessment will be with intraoral scan with CAD-CAM preoperative and 6 months postoperative.
Esthetic assessment will be done by means of the root coverage esthetic score (RES), this score estimates five variables: gingival margin level (GM), the contour of the marginal tissue (MTC), soft tissue texture (STT), location of mucogingival junction (MGJ), and gingival color (GC). Zero, 3, or 6 points will be used for the estimation of the location of the gingival margin, while a score of 0 or 1 point will be used for each of the other variables.GM. Zero points = no root coverage (in which the gingival margin is in equal level to the baseline or migrated apically); 3 points = partial coverage; 6 points = Complete coverage.
MTC. Zero points = asymmetrical gingival margin (does not track the CEJ); 1point = appropriate marginal contour/ scalloped gingival margin (tracks the CEJ).
STT. Zero points = scar development; 1 point = absence of scar. MGJ. Zero points =MGJ is not uniform with the MGJ of neighboring teeth; 1 point = MGJ is uniform with the MGJ of neighboring teeth.
GC. Zero points = tissue color differs from gingival color of neighboring teeth; 1 point = normal color and unification with the neighboring soft tissues.
Accordingly, the perfect esthetic score is 10. Satisfaction questionnaire, to score degree of pain experienced during and after treatment and the degree of patient satisfaction with the cosmetic results of the procedure.
All data will be collected blindly and subjected to statistical analysis.
- Conditions
- Recession
- Being tested
- interdental papilla reconstruction with L-PRF
- Keywords
- interdental papilla reconstruction, Leucocyte-Platelet Rich Fibrin (L-PRF)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
interdental papilla reconstruction with L-PRFProcedure or surgery
interdental papilla reconstruction with single layer of L-PRF versus multiple layers of L-PRF
| Study group | Role | What they receive |
|---|---|---|
| single layer of L-PRF | Experimental | single layer of L-PRF will be put in the vertical incision Receives: Procedure: interdental papilla reconstruction with L-PRF |
| multiple layers of L-PRF | Experimental | multiple layers of L-PRF will be put in the vertical incision Receives: Procedure: interdental papilla reconstruction with L-PRF |
What is being measured
The primary outcome is the main question the study is designed to answer.
clinical assessment
papillary height from the tip of the papilla to mesial line angle
Measured: change from baseline to 6 months
Secondary outcomes (1)
volumetric analysis
intraoral scan with CAD-CAM
Measured: change from baseline to 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Sep 2019
- Study startJan 2016
- Primary completionJul 2019
- Study completionAug 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for RecessionStudies of the same condition, open and under way.
- More trials run by Ain Shams 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
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sara Amir ahmed Lashin, Ain Shams University
- Investigators
- Nivine H. kheir el den, professor, Study chair, faculty of dentistry- ain shams university
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04091802
- Sponsor's protocol ID
- FDASU-RECO 1214403
- Status last verified
- Sep 2019
- First submitted
- 27 Aug 2019
- Last updated
- 19 Sep 2019
- 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 19 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Monolayer Versus Multilayer Leucocyte-Platelet Rich Fibrin (L-PRF) in Interdental Papillary Reconstruction" (A Randomized Controlled Clinical Study)
- ClinicalTrials.gov ID
- NCT04091802
- Acronym / sponsor ID
- FDASU-RECO 1214403
- Conditions
- Recession
- Keywords
- interdental papilla reconstruction, Leucocyte-Platelet Rich Fibrin (L-PRF)
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- Jan 2016 (actual)
- Primary completion
- Jul 2019 (actual)
- Study completion
- Aug 2019 (actual)
- First posted
- 17 Sep 2019 (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 interdental papilla is very small but it has a great implication from an aesthetic view, more specifically in the anterior region because it is always displayed during smiling. The lack of interdental papilla due to periodontal disease or periodontal therapy leads to aesthetic problems with food stagnation as well as phonetic problem due to the space that allows passage of the air or saliva. Leukocyte-PRF (L-PRF) membrane was developed which includes the majority of the platelets in addition to half of the leukocytes so that lymphocytes as well as the platelet growth factors are trapped inside a fibrin network. Multiple layers of L-PRF may have observable effect on tissue regeneration because it increases the number of growth factors and acts as a strong scaffold which helps in creeping of the cells along it as it remains active and in place for more than 7 days. Thus, the aim of this study will be conducted to compare the effect of one layer versus multiple layers of L-PRF in interdental papillary reconstruction.
Detailed description
A total of 20 patients will be selected who are caring about esthetics and concerned to go through the management of eradication of "black triangles" by interdental papillae reconstruction in esthetic zone and systemically free with Nordland's class I or II and The vertical distance from the interdental contact point to the crest of the interdental bone is ≥ 6 mm as measured by bone sounding, A band of keratinized tissue should be present around the test teeth ≥ 2 mm, Gingival biotype of the area to be treated is ≥ 2 mm in thickness.
The study protocol will be explained in details to all patients. Then a signed informed consent will be obtained from the patients. The data obtained from patients as well as the results of the follow up will be kept confidential.
The study will be introduced to ethics' committee of Faculty of Dentistry Ain Shams University and has to be approved before the start of the study Eligible patients will be randomized in a 1:1 ratio into two groups; (Group I) included 10 patients and (Group II) included 10 patients. The computer-generated randomization assignment (blocks of 4) and allocation concealment will be performed by sealed envelopes containing the randomization number prepared by non involved member and sent to principle investigator to assign the interventions to patients Group I: 10 patients will undergo interdental papillary reconstruction using one layer of L-PRF.
Group II: 10 patients will receive interdental papillary reconstruction using multiple layers of L-PRF (Two or more according to the compressibility in which if ≥1mm, it needs one more layer, and if ≤1 mm, then no need to more than 2 layers; it cannot be standardized).
Procedure:
- All patients will receive Phase I therapy including oral hygiene measures and scaling and root planning whenever indicated.
- Preparation of recipient site: The preparation of the recipient site is similar to that described by Reddy.
- Anasthesia of the surgical field.
- A single vertical incision will be made in the buccal vestibule apical to the mucogingival junction in the mid interproximal area of the papilla to be treated.
- Intrasulcular releasing incisions will be made on the teeth adjacent to the papilla to be augmented and extend to the buccal and palatal aspects without altering the integrity of the papilla.
- The incisions will maintain the full height and thickness of the gingiva.
- Papilla will be undermined carefully to maintain integrity and a space will be created under the papilla by elevating it coronally.
- Preparation of L-PRF: L-PRF will be prepared according to Chaukroun's et al. 2001. Immediately prior to the surgery, 10 ml of blood (for each membrane) will be collected from the patient by venipuncture of antecubital vein and then drawn quickly into sterile glass tube with no anticoagulant and immediately centrifuged at 2700 rpm for 12 minutes at room temperature by using the Intra-Spin centrifuge (Intra-Lock). Then L-PRF clot will be removed by sterile tweezers and placed in Xpression™ kit for gentle compression by gravity. Then L-PRF will be ready to be used after 5 minutes (For group II, membranes will be sutured together before placement in the vertical incision).
- Placement and suturing of L-PRF in the recipient site: The L-PRF membrane will be trimmed to the desired shape and size and then placed under the papilla and mucogingival complex through the vertical incision to fill the black space. Then incision will be closed with 5-0 polypropylene simple interrupted sutures.
- Post operative management:
It will include pain control using anti-inflammatory and analgesics (Brufen 600 mg) when needed and twice mouth rinse with chlorohexidine gluconate daily for one week.
All Clinical and volumetric measurements will be carried out at baseline and after 6 months follow up and esthetic assessment will be done.
Clinical assessment will be Plaque score index (PI), gingival score index (GI), papillary height from the tip of the papilla to mesial line angle, Nordland and Tarnaw classification.
volumetric assessment will be with intraoral scan with CAD-CAM preoperative and 6 months postoperative.
Esthetic assessment will be done by means of the root coverage esthetic score (RES), this score estimates five variables: gingival margin level (GM), the contour of the marginal tissue (MTC), soft tissue texture (STT), location of mucogingival junction (MGJ), and gingival color (GC). Zero, 3, or 6 points will be used for the estimation of the location of the gingival margin, while a score of 0 or 1 point will be used for each of the other variables.GM. Zero points = no root coverage (in which the gingival margin is in equal level to the baseline or migrated apically); 3 points = partial coverage; 6 points = Complete coverage.
MTC. Zero points = asymmetrical gingival margin (does not track the CEJ); 1point = appropriate marginal contour/ scalloped gingival margin (tracks the CEJ).
STT. Zero points = scar development; 1 point = absence of scar. MGJ. Zero points =MGJ is not uniform with the MGJ of neighboring teeth; 1 point = MGJ is uniform with the MGJ of neighboring teeth.
GC. Zero points = tissue color differs from gingival color of neighboring teeth; 1 point = normal color and unification with the neighboring soft tissues.
Accordingly, the perfect esthetic score is 10. Satisfaction questionnaire, to score degree of pain experienced during and after treatment and the degree of patient satisfaction with the cosmetic results of the procedure.
All data will be collected blindly and subjected to statistical analysis.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| single layer of L-PRF | Experimental | Procedure: interdental papilla reconstruction with L-PRFsingle layer of L-PRF will be put in the vertical incision |
| multiple layers of L-PRF | Experimental | Procedure: interdental papilla reconstruction with L-PRFmultiple layers of L-PRF will be put in the vertical incision |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- 1. Patients diagnosed with black triangles. 2. Both genders aged from 18-40 years. 3. Patients should be systemically free. 4. Patients with Nordland's class I or II. Nordland and Tarnow classified the interdental papilla loss; the classification is based on three anatomic landmarks: the contact point interdentally, the coronal level of the CEJ interproximally and the facial apical level of the cemento-enamel junction (CEJ). [Nordland WP, et al, 1998] Four classes were identified
- 5. The vertical distance from the interdental contact point to the crest of the interdental bone is ≥ 6 mm as measured by bone sounding.
- 6. A band of keratinized tissue should be present around the test teeth ≥ 2 mm. 7. Gingival biotype of the area to be treated is ≥ 2 mm in thickness.
Key exclusion criteria (7 listed)
- Acute periapical lesion.
- moderate to severe form of periodontitis.
- Pregnancy and lactation.
- parafunctional habits.
- Smoking, alcoholics or drug abusers.
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 |
|---|---|---|
| interdental papilla reconstruction with L-PRFinterdental papilla reconstruction with single layer of L-PRF versus multiple layers of L-PRF | Procedure or surgery | multiple layers of L-PRF, single layer of L-PRF |
Primary outcome
clinical assessment
Time frame: change from baseline to 6 months
papillary height from the tip of the papilla to mesial line angle
1 secondary outcome
volumetric analysis
Time frame: change from baseline to 6 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 19 Sep 2019.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
Nivine H. kheir el den, professor study chair
faculty of dentistry- ain shams university
Questions about this trial
What is this clinical trial studying?
A study testing interdental papilla reconstruction with L-PRF in people with Recession, run by Ain Shams University.
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 7 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 19 Sep 2019. Status can change between updates, so confirm with the study contact before making plans.
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?
clinical assessment (time frame: change from baseline to 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 19 Sep 2019.