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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.
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:
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:
Second visit:
After 4-6 weeks of initial therapy, patients will be re-examined, and the baseline clinical parameters will be recorded as follows:
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
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| A-PRF | Experimental | Surgical treatment A-PRF membrane |
|
| SCTG | Active Comparator | Surgical treatment with SCTG |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| interdental papilla surgical reconstructiion | Procedure | Surgical treatment of receding interdentalpapillae |
|
| Measure | Description | Time Frame |
|---|---|---|
| papilla height | change of papillae height will be recorded using a graduated periodontal probe (UNC 15 probe) | base line , 3, 6, 9, and 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| patient satisfaction | patients opinion about esthetic improvement | 3 and 12 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| sanabel barakat | Contact | 00201550071457 | snabel.barakat@dentistry.cu.edu.eg |
| Name | Affiliation | Role |
|---|---|---|
| Hani ElNahass, Ph D | Cairo University | Study Chair |
| Samar ElKohouly, Ph D | Cairo University | Principal Investigator |
| sanabel barakat, MSC |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Faculty of Dentistry | Recruiting | Cairo | Egypt |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29875563 | Background | 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. | |
| 15016030 | Background | Cardaropoli 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. |
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Randomized clinical trial with 1:1 ratio.
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| Cairo University |
| Principal Investigator |
| Background | Augusta, Maria and Matas Hennig. 2016. "Absence of Interdental Papilla - Systematic Review of Available Therapeutic Modalities." Stomatos 22(43):31-43. |
| 29440789 | Background | 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. |
| 29683498 | Background | Clark 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. |
| 24362634 | Background | Eren 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. |
| 24945603 | Background | Ghanaati 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. |