RecessionNCT05031169
Surgical Management of Interdental Papilla Recession With Advanced Platelet Rich Fibrin or Connective Tissue Graft
A study testing interdental papilla surgical reconstructiion in people with Recession, run by Cairo University at 1 site in Egypt.
Trial summary
deficient interdental papillae witt be surgically reconstructed. in one group, connective tissue graft (SCTG) will be used for papillae augmentation, while in the other group, advanced platelet rich fibrin (A-PRF). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Recession
- What is being tested?
- interdental papilla surgical reconstructiion
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Sep 2020to Dec 2022
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Be healthy adults older than 18 years of age and presenting at least one deficient papilla with papilla presence index 2 or 3
- Have Interproximal CAL ≤ 3 mm
- Have probing depth ≤ 3mm
- Distance between the alveolar bone crest and contact point is less than 7mm.
Who cannot join
- Smoking.
- Pregnancy and lactation.
- Carious and non-carious cervical lesion in the involved teeth around the papilla.
- Restoration in teeth around the papilla (filling, crown, bridge, facings, clasp of a partial denture).
- Open contacts and non-vital teeth
- Poor oral hygiene with plaque index > 20 %.
Show all 9Show fewer
- Tooth mobility
- History of medication in the previous 3 months
- History of periodontal surgery in the site to be treated in the past 12 months
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Faculty of Dentistry
Cairo
Hani ElNahass, PhD, 01000252603, nahass77@gmail.com
About this study
Official title: Evaluation of Surgical Management of Interdental Papilla Recession With Advanced Platelet Rich Fibrin Compared to Subepthelial Connective Tissue Graft. A Randomized Controlled Trial
deficient interdental papillae witt be surgically reconstructed. in one group, connective tissue graft (SCTG) will be used for papillae augmentation, while in the other group, advanced platelet rich fibrin (A-PRF). the height of the papillae will be measured preoperatively as well as post operatively at 3, 6 ,9 and 12 months.
Read the detailed description
The aim of this study is to compare the effect of A-PRF membrane to SCTG when used as grafting material with the Han and Takei's approach to reconstruct receding interdental papilla and assess deference in papilla height between the study groups.
The clinical parameters that will be evaluated are:
- Papilla height (PH)
- Clinical attachment level (CAL)
- Probing depth (PD)
- Post-operative patients' satisfaction about the esthetic outcome
- Post-operative pain level among patients
Study settings:
This study will be conducted in the postgraduate periodontology clinics in the faculty of dentistry, Cairo University. The participants will be selected from the outpatient clinic of the department.
interventionsa:
The first visit:
- Eligible participants will be interviewed to report medical and dental histories.
- The participants will receive full mouth dental and periodontal examination.
- Initial periodontal treatment (supragingival scaling and sub gingival debridement) as indicated.
- Patients will be given oral hygiene instruction on proper tooth brushing and flossing.
- They will be advised to use chlorhexidine mouth wash 0.12% twice daily for 2 weeks.
Second visit:
After 4-6 weeks of initial therapy, patients will be re-examined, and the baseline clinical parameters will be recorded as follows:
- Full mouth plaque index and gingival index.
- Site specific plaque index and gingival index.
- Type of Papilla deficiency (classification).
- Papilla height
- Clinical attachment level
- Probing depth
The patients then will be randomly allocated to one of the study groups.
Test group:
Deficient papillae in this group will be treated surgically and A-PRF membrane will be used as a grafting material.
Preparation of A-PRF:
A-PRF preparation protocol will be as described by (Clark et al. 2018):
A blood sample of 10 ml will be obtained from the patient and immediately centrifuged at 1300 rpm for 8 minutes.
Control group:
In this group, papilla recession will be treated surgically and the SCTG will be used as a grafting material.
sample size calculation was based on a previous study. fourteen experimental subjects and 14 control subjects are required to be able to reject the null hypothesis that the population means of the experimental and the control groups are equal with probability (power) 0.8. The type I error probability associated with this test of this null hypothesis is 0.05.
To compensate for anticipated missing data during follow up, this number is increased to 16 per group.
Recruitment
- Patients will be selected from the outpatient clinic of the Oral Medicine and Periodontology Department, Faculty of Oral and Dental Medicine-Cairo University
- Screening of patients will continue until the target sample is achieved.
Allocation
Randomization:
Patients will be randomly assigned to either test or control group using computer generated randomization (www.randomizer.org) which will be performed by the supervisor. The patients will be allocated to either test or control group.
Allocation concealment mechanism:
The two groups will be equally prepared for both surgical procedures. Then the decision of which group will receive papilla treatment with A-PRF (test) and which will receive papilla treatment with SCTG (control) will be taken according to the randomized numbers placed in opaque sealed envelopes. The number will be picked by the supervisor.
Implementation:
- All patients who provide an informed consent for participation as well as fulfill the inclusion criteria will be randomized.
- Conditions
- Recession
- Being tested
- interdental papilla surgical reconstructiion
- Keywords
- interdental papilla reconstriction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
interdental papilla surgical reconstructiionProcedure or surgery
Surgical treatment of receding interdentalpapillae
| Study group | Role | What they receive |
|---|---|---|
| A-PRF | Experimental | Surgical treatment A-PRF membrane Receives: Procedure: interdental papilla surgical reconstructiion |
| SCTG | Active comparator | Surgical treatment with SCTG Receives: Procedure: interdental papilla surgical reconstructiion |
What is being measured
The primary outcome is the main question the study is designed to answer.
papilla height
change of papillae height will be recorded using a graduated periodontal probe (UNC 15 probe)
Measured: base line , 3, 6, 9, and 12 months
Secondary outcomes (1)
patient satisfaction
patients opinion about esthetic improvement
Measured: 3 and 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Sep 2021
- Study start1 Sep 2020
- Primary completionDec 2021 (estimated)
- Study completionDec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for RecessionStudies of the same condition, open and under way.
- More trials run by Cairo 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
- Randomized clinical trial with 1:1 ratio.
- Masking
- None (open label)
- Enrolment
- 32 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sanabel Osama Omran Barakat, Cairo University
- Investigators
- Hani ElNahass, Ph D, Study chair, Cairo UniversitySamar ElKohouly, Ph D, Principal investigator, Cairo Universitysanabel barakat, MSC, Principal investigator, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05031169
- Sponsor's protocol ID
- PER 331
- Status last verified
- Aug 2021
- First submitted
- 29 Aug 2021
- Last updated
- 1 Sep 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Ahila E, Saravana Kumar R, Reddy VK, Pratebha B, Jananni M, Priyadharshini V. Augmentation of Interdental Papilla with Platelet-rich Fibrin. Contemp Clin Dent. 2018 Apr-Jun;9(2):213-217. doi: 10.4103/ccd.ccd_812_17.
PubMed 29875563Cardaropoli D, Re S, Corrente G, Abundo R. Reconstruction of the maxillary midline papilla following a combined orthodontic-periodontic treatment in adult periodontal patients. J Clin Periodontol. 2004 Feb;31(2):79-84. doi: 10.1111/j.0303-6979.2004.00451.x.
PubMed 15016030Augusta, Maria and Matas Hennig. 2016. "Absence of Interdental Papilla - Systematic Review of Available Therapeutic Modalities." Stomatos 22(43):31-43.
Chaulkar PP, Mali RS, Mali AM, Lele PA, Patil PA. A comparative evaluation of papillary reconstruction by modified Beagle's technique with the Beagle's surgical technique: A clinical and radiographic study. J Indian Soc Periodontol. 2017 May-Jun;21(3):218-223. doi: 10.4103/jisp.jisp_166_17.
PubMed 29440789Clark D, Rajendran Y, Paydar S, Ho S, Cox D, Ryder M, Dollard J, Kao RT. Advanced platelet-rich fibrin and freeze-dried bone allograft for ridge preservation: A randomized controlled clinical trial. J Periodontol. 2018 Apr;89(4):379-387. doi: 10.1002/JPER.17-0466.
PubMed 29683498Eren G, Atilla G. Platelet-rich fibrin in the treatment of localized gingival recessions: a split-mouth randomized clinical trial. Clin Oral Investig. 2014 Nov;18(8):1941-8. doi: 10.1007/s00784-013-1170-5. Epub 2013 Dec 22.
PubMed 24362634Ghanaati S, Booms P, Orlowska A, Kubesch A, Lorenz J, Rutkowski J, Landes C, Sader R, Kirkpatrick C, Choukroun J. Advanced platelet-rich fibrin: a new concept for cell-based tissue engineering by means of inflammatory cells. J Oral Implantol. 2014 Dec;40(6):679-89. doi: 10.1563/aaid-joi-D-14-00138.
PubMed 24945603
Study at a glance
From the registry record, last updated by the sponsor on 1 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Surgical Management of Interdental Papilla Recession With Advanced Platelet Rich Fibrin Compared to Subepthelial Connective Tissue Graft. A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT05031169
- Acronym / sponsor ID
- PER 331
- Conditions
- Recession
- Keywords
- interdental papilla reconstriction
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 32 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 1 Sep 2020 (actual)
- Primary completion
- Dec 2021 (estimated)
- Study completion
- Dec 2022 (estimated)
- First posted
- 1 Sep 2021 (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.
deficient interdental papillae witt be surgically reconstructed. in one group, connective tissue graft (SCTG) will be used for papillae augmentation, while in the other group, advanced platelet rich fibrin (A-PRF). the height of the papillae will be measured preoperatively as well as post operatively at 3, 6 ,9 and 12 months.
Detailed description
The aim of this study is to compare the effect of A-PRF membrane to SCTG when used as grafting material with the Han and Takei's approach to reconstruct receding interdental papilla and assess deference in papilla height between the study groups.
The clinical parameters that will be evaluated are:
- Papilla height (PH)
- Clinical attachment level (CAL)
- Probing depth (PD)
- Post-operative patients' satisfaction about the esthetic outcome
- Post-operative pain level among patients
Study settings:
This study will be conducted in the postgraduate periodontology clinics in the faculty of dentistry, Cairo University. The participants will be selected from the outpatient clinic of the department.
interventionsa:
The first visit:
- Eligible participants will be interviewed to report medical and dental histories.
- The participants will receive full mouth dental and periodontal examination.
- Initial periodontal treatment (supragingival scaling and sub gingival debridement) as indicated.
- Patients will be given oral hygiene instruction on proper tooth brushing and flossing.
- They will be advised to use chlorhexidine mouth wash 0.12% twice daily for 2 weeks.
Second visit:
After 4-6 weeks of initial therapy, patients will be re-examined, and the baseline clinical parameters will be recorded as follows:
- Full mouth plaque index and gingival index.
- Site specific plaque index and gingival index.
- Type of Papilla deficiency (classification).
- Papilla height
- Clinical attachment level
- Probing depth
The patients then will be randomly allocated to one of the study groups.
Test group:
Deficient papillae in this group will be treated surgically and A-PRF membrane will be used as a grafting material.
Preparation of A-PRF:
A-PRF preparation protocol will be as described by (Clark et al. 2018):
A blood sample of 10 ml will be obtained from the patient and immediately centrifuged at 1300 rpm for 8 minutes.
Control group:
In this group, papilla recession will be treated surgically and the SCTG will be used as a grafting material.
sample size calculation was based on a previous study. fourteen experimental subjects and 14 control subjects are required to be able to reject the null hypothesis that the population means of the experimental and the control groups are equal with probability (power) 0.8. The type I error probability associated with this test of this null hypothesis is 0.05.
To compensate for anticipated missing data during follow up, this number is increased to 16 per group.
Recruitment
- Patients will be selected from the outpatient clinic of the Oral Medicine and Periodontology Department, Faculty of Oral and Dental Medicine-Cairo University
- Screening of patients will continue until the target sample is achieved.
Allocation
Randomization:
Patients will be randomly assigned to either test or control group using computer generated randomization (www.randomizer.org) which will be performed by the supervisor. The patients will be allocated to either test or control group.
Allocation concealment mechanism:
The two groups will be equally prepared for both surgical procedures. Then the decision of which group will receive papilla treatment with A-PRF (test) and which will receive papilla treatment with SCTG (control) will be taken according to the randomized numbers placed in opaque sealed envelopes. The number will be picked by the supervisor.
Implementation:
- All patients who provide an informed consent for participation as well as fulfill the inclusion criteria will be randomized.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Randomized clinical trial with 1:1 ratio.
| Arm | Type | Receives |
|---|---|---|
| A-PRF | Experimental | Procedure: interdental papilla surgical reconstructiionSurgical treatment A-PRF membrane |
| SCTG | Active comparator | Procedure: interdental papilla surgical reconstructiionSurgical treatment with SCTG |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Be healthy adults older than 18 years of age and presenting at least one deficient papilla with papilla presence index 2 or 3
- Have Interproximal CAL ≤ 3 mm
- Have probing depth ≤ 3mm
- Distance between the alveolar bone crest and contact point is less than 7mm.
Key exclusion criteria (9 listed)
- Smoking.
- Pregnancy and lactation.
- Carious and non-carious cervical lesion in the involved teeth around the papilla.
- Restoration in teeth around the papilla (filling, crown, bridge, facings, clasp of a partial denture).
- Open contacts and non-vital teeth
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 surgical reconstructiionSurgical treatment of receding interdentalpapillae | Procedure or surgery | A-PRF, SCTG |
Primary outcome
papilla height
Time frame: base line , 3, 6, 9, and 12 months
change of papillae height will be recorded using a graduated periodontal probe (UNC 15 probe)
1 secondary outcome
patient satisfaction
Time frame: 3 and 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Sep 2021.
- Background: PubMed 29875563Ahila E, Saravana Kumar R, Reddy VK, Pratebha B, Jananni M, Priyadharshini V. Augmentation of Interdental Papilla with Platelet-rich Fibrin. Contemp Clin Dent. 2018 Apr-Jun;9(2):213-217. doi: 10.4103/ccd.ccd_812_17.
- Background: PubMed 15016030Cardaropoli D, Re S, Corrente G, Abundo R. Reconstruction of the maxillary midline papilla following a combined orthodontic-periodontic treatment in adult periodontal patients. J Clin Periodontol. 2004 Feb;31(2):79-84. doi: 10.1111/j.0303-6979.2004.00451.x.
- BackgroundAugusta, Maria and Matas Hennig. 2016. "Absence of Interdental Papilla - Systematic Review of Available Therapeutic Modalities." Stomatos 22(43):31-43.
- Background: PubMed 29440789Chaulkar PP, Mali RS, Mali AM, Lele PA, Patil PA. A comparative evaluation of papillary reconstruction by modified Beagle's technique with the Beagle's surgical technique: A clinical and radiographic study. J Indian Soc Periodontol. 2017 May-Jun;21(3):218-223. doi: 10.4103/jisp.jisp_166_17.
- Background: PubMed 29683498Clark D, Rajendran Y, Paydar S, Ho S, Cox D, Ryder M, Dollard J, Kao RT. Advanced platelet-rich fibrin and freeze-dried bone allograft for ridge preservation: A randomized controlled clinical trial. J Periodontol. 2018 Apr;89(4):379-387. doi: 10.1002/JPER.17-0466.
- Background: PubMed 24362634Eren G, Atilla G. Platelet-rich fibrin in the treatment of localized gingival recessions: a split-mouth randomized clinical trial. Clin Oral Investig. 2014 Nov;18(8):1941-8. doi: 10.1007/s00784-013-1170-5. Epub 2013 Dec 22.
- Background: PubMed 24945603Ghanaati S, Booms P, Orlowska A, Kubesch A, Lorenz J, Rutkowski J, Landes C, Sader R, Kirkpatrick C, Choukroun J. Advanced platelet-rich fibrin: a new concept for cell-based tissue engineering by means of inflammatory cells. J Oral Implantol. 2014 Dec;40(6):679-89. doi: 10.1563/aaid-joi-D-14-00138.
- 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.
Hani ElNahass, Ph D study chair
Cairo University
Samar ElKohouly, Ph D principal investigator
Cairo University
sanabel barakat, MSC principal investigator
Cairo 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 interdental papilla surgical reconstructiion in people with Recession, run by Cairo 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 4 inclusion and 9 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: status not confirmed, as of the sponsor's last update on 1 Sep 2021. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact sanabel barakat (00201550071457, snabel.barakat@dentistry.cu.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
papilla height (time frame: base line , 3, 6, 9, and 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05031169, which also lists 7 linked publications.
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 1 Sep 2021.