Surgical Management of Interdental Papilla Recession With Advanced Platelet Rich Fibrin or Connective Tissue Graft

NCT05031169 | Unknown

• 1 other identifier: PER 331
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

Brief 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). the height of the papillae will be measured preoperatively as well as post operatively at 3, 6 ,9 and 12 months.

Conditions

Recession

Keywords

interdental papilla reconstriction

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (1)

• patient satisfaction

  3 and 12 months

Study Arms (2)

A-PRF

EXPERIMENTAL

Surgical treatment A-PRF membrane

Procedure: interdental papilla surgical reconstructiion

SCTG

ACTIVE COMPARATOR

Surgical treatment with SCTG

Procedure: interdental papilla surgical reconstructiion

Interventions

interdental papilla surgical reconstructiion PROCEDURE

Surgical treatment of receding interdentalpapillae

A-PRF; SCTG

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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 %.
• 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

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

Faculty of Dentistry

Cairo, Egypt

RECRUITING

Related Publications (7)

• 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.

  PMID: 29875563 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.

  PMID: 15016030 BACKGROUND

• Augusta, Maria and Matas Hennig. 2016. "Absence of Interdental Papilla - Systematic Review of Available Therapeutic Modalities." Stomatos 22(43):31-43.

  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.

  PMID: 29440789 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.

  PMID: 29683498 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.

  PMID: 24362634 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.

  PMID: 24945603 BACKGROUND

Study Officials

• Hani ElNahass, Ph D

  Cairo University

  STUDY CHAIR

• Samar ElKohouly, Ph D

  Cairo University

  PRINCIPAL INVESTIGATOR

• sanabel barakat, MSC

  Cairo University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

sanabel barakat

CONTACT

00201550071457; snabel.barakat@dentistry.cu.edu.eg

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Ph d candidate

Model Details: Randomized clinical trial with 1:1 ratio.

Study Record Dates

• First Submitted: August 29, 2021
• First Posted: September 1, 2021
• Study Start: September 1, 2020
• Primary Completion: December 1, 2021
• Study Completion: December 1, 2022
• Last Updated: September 1, 2021

Record last verified: 2021-08

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)