Comparison of the Efficacy of Platelet-rich Fibrin and Connective Tissue Graft in Interdental Papilla Reconstruction

NCT05207696 | Completed DMC

• 1 other identifier: GO 18/780
• Study Type: observational
• Target: 55
• Locations: 1 country
• Sites: 1

Brief Summary

Aim: To evaluate the efficacy of platelet-rich fibrin (PRF) or connective tissue graft (CTG) in papilla reconstruction (PR) with semilunar incision (SI) technique. Materials and Methods: A total of 55 sites (27 CTG and 28 PRF) from 20 patients who underwent PR with either PRF or CTG placed with SI in the maxillary anterior region were included in the study. Baseline (BL) and follow-up (T1( first month), T3 (third month), T6 (sixth month)) clinical data including periodontal evaluations (gingival index (GI), plaque index (PI), papillary bleeding index, pocket depth (PD), keratinized tissue width (KTW), gingival recession), papilla-associated recordings (alveolar crest-interdental contact point (AC-IC), alveolar crest-papilla tip (AC-PT), papilla tip-interdental contact point (PT-IC), papilla height loss (PHL), interdental tissue stroke (ITS) and papilla presence index (PPI)) and patient satisfaction were analyzed.

Conditions

To Evaluate the Efficacy of Platelet-rich Fibrin in Papilla Reconstruction; To Evaluate the Efficacy of Connective Tissue Graft in Papilla Reconstruction

Keywords

connective tissue graft; papilla reconstruction; platelet rich fibrin

Outcome Measures

Primary Outcomes (24)

• Alveolar crest-Interdental contact point (AC-IC mm)

  Crestal bone height was measured after administering local anesthesia for each mesiofacial or distofacial test site. UNC-15(HuFriedy, Chicago, IL, USA) periodontal probe was positioned inter-proximally in the gingival sulcus in a corono - apical direction which was parallel to the long axis of the tooth. The probe was advanced apically until it contacted the crest of the alveolar bone. The distance between the crestal bone and interdental contact point was reported as AC-IC . (measurements are in millimeters)

  baseline

• Alveolar crest-Interdental contact point (AC-IC mm)

  Crestal bone height was measured after administering local anesthesia for each mesiofacial or distofacial test site. UNC-15(HuFriedy, Chicago, IL, USA) periodontal probe was positioned inter-proximally in the gingival sulcus in a corono - apical direction which was parallel to the long axis of the tooth. The probe was advanced apically until it contacted the crest of the alveolar bone. The distance between the crestal bone and interdental contact point was reported as AC-IC . (measurements are in millimeters)

  T1:1st month

• Alveolar crest-Interdental contact point (AC-IC mm)

  Crestal bone height was measured after administering local anesthesia for each mesiofacial or distofacial test site. UNC-15(HuFriedy, Chicago, IL, USA) periodontal probe was positioned inter-proximally in the gingival sulcus in a corono - apical direction which was parallel to the long axis of the tooth. The probe was advanced apically until it contacted the crest of the alveolar bone. The distance between the crestal bone and interdental contact point was reported as AC-IC . (measurements are in millimeters)

  T3:3rd month

• Alveolar crest-Interdental contact point (AC-IC mm)

  Crestal bone height was measured after administering local anesthesia for each mesiofacial or distofacial test site. UNC-15(HuFriedy, Chicago, IL, USA) periodontal probe was positioned inter-proximally in the gingival sulcus in a corono - apical direction which was parallel to the long axis of the tooth. The probe was advanced apically until it contacted the crest of the alveolar bone. The distance between the crestal bone and interdental contact point was reported as AC-IC . (measurements are in millimeters)

  T6: 6th month

• Alveolar crest-Papilla tip (AC-PT mm)

  Crestal bone height was measured after administering local anesthesia for each mesiofacial or distofacial test site. UNC-15(HuFriedy, Chicago, IL, USA) periodontal probe was positioned inter-proximally in the gingival sulcus in a corono - apical direction which was parallel to the long axis of the tooth. The probe was advanced apically until it contacted the crest of the alveolar bone. The distance between the crestal bone and the tip of the interdental papilla was reported as AC-PT. (measurements are in millimeters)

  baseline

• Alveolar crest-Papilla tip (AC-PT mm)

  Crestal bone height was measured after administering local anesthesia for each mesiofacial or distofacial test site. UNC-15(HuFriedy, Chicago, IL, USA) periodontal probe was positioned inter-proximally in the gingival sulcus in a corono - apical direction which was parallel to the long axis of the tooth. The probe was advanced apically until it contacted the crest of the alveolar bone. The distance between the crestal bone and the tip of the interdental papilla was reported as AC-PT. (measurements are in millimeters)

  T1:1st month

• Alveolar crest-Papilla tip (AC-PT mm)

  Crestal bone height was measured after administering local anesthesia for each mesiofacial or distofacial test site. UNC-15(HuFriedy, Chicago, IL, USA) periodontal probe was positioned inter-proximally in the gingival sulcus in a corono - apical direction which was parallel to the long axis of the tooth. The probe was advanced apically until it contacted the crest of the alveolar bone. The distance between the crestal bone and the tip of the interdental papilla was reported as AC-PT. (measurements are in millimeters)

  T3:3rd month

• Alveolar crest-Papilla tip (AC-PT mm)

  Crestal bone height was measured after administering local anesthesia for each mesiofacial or distofacial test site. UNC-15(HuFriedy, Chicago, IL, USA) periodontal probe was positioned inter-proximally in the gingival sulcus in a corono - apical direction which was parallel to the long axis of the tooth. The probe was advanced apically until it contacted the crest of the alveolar bone. The distance between the crestal bone and the tip of the interdental papilla was reported as AC-PT. (measurements are in millimeters)

  T6: 6th month

• Papilla tip-Interdental contact point (PT-IC mm)

  the periodontal probe was positioned inter-proximally. The distance between interdental contact point and the tip of the interdental papilla was reported as PT-IC. (measurements are in millimeters)

  baseline

• Papilla tip-Interdental contact point (PT-IC mm)

  the periodontal probe was positioned inter-proximally. The distance between interdental contact point and the tip of the interdental papilla was reported as PT-IC. (measurements are in millimeters)

  T1:1st month

• Papilla tip-Interdental contact point (PT-IC mm)

  the periodontal probe was positioned inter-proximally. The distance between interdental contact point and the tip of the interdental papilla was reported as PT-IC. (measurements are in millimeters)

  T3:3rd month

• Papilla tip-Interdental contact point (PT-IC mm)

  the periodontal probe was positioned inter-proximally. The distance between interdental contact point and the tip of the interdental papilla was reported as PT-IC. (measurements are in millimeters)

  T6: 6th month

• Papilla Height Loss (PHL)(Nordland and Tarnow classification system)

  Each interdental papilla was scored as 0-3 based upon Nordland and Tarnow's classification system The following scores were assigned to the papilla at baseline, T1,T3 and T6. Normal:Interdental papilla fills embrasure space to the apical extent of the interdental contact point/area. Class-I. The tip of the interdental papilla lies between the interdental contact point and the most coronal extent of the inter proximal CEJ (the cemento-enamel junction) (space present but inter proximal CEJ is not visible) Class-II.The tip of the interdental papilla lies at or apical to the interproximal CEJ but coronal to the apical extent of the facial CEJ(interproximal CEJ visible) Class-III.The tip of the interdental papilla lies level with or apical to the facial CEJ

  baseline

• Papilla Height Loss (PHL)(Nordland and Tarnow classification system)

  Each interdental papilla was scored as 0-3 based upon Nordland and Tarnow's classification system The following scores were assigned to the papilla at baseline, T1,T3 and T6. Normal:Interdental papilla fills embrasure space to the apical extent of the interdental contact point/area. Class-I. The tip of the interdental papilla lies between the interdental contact point and the most coronal extent of the inter proximal CEJ (the cemento-enamel junction) (space present but inter proximal CEJ is not visible) Class-II.The tip of the interdental papilla lies at or apical to the interproximal CEJ but coronal to the apical extent of the facial CEJ(interproximal CEJ visible) Class-III.The tip of the interdental papilla lies level with or apical to the facial CEJ

  T1:1st month

• Papilla Height Loss (PHL)(Nordland and Tarnow classification system)

  Each interdental papilla was scored as 0-3 based upon Nordland and Tarnow's classification system The following scores were assigned to the papilla at baseline, T1,T3 and T6. Normal:Interdental papilla fills embrasure space to the apical extent of the interdental contact point/area. Class-I. The tip of the interdental papilla lies between the interdental contact point and the most coronal extent of the inter proximal CEJ (the cemento-enamel junction) (space present but inter proximal CEJ is not visible) Class-II.The tip of the interdental papilla lies at or apical to the interproximal CEJ but coronal to the apical extent of the facial CEJ(interproximal CEJ visible) Class-III.The tip of the interdental papilla lies level with or apical to the facial CEJ

  T3:3rd month

• Papilla Height Loss (PHL)(Nordland and Tarnow classification system)

  Each interdental papilla was scored as 0-3 based upon Nordland and Tarnow's classification system The following scores were assigned to the papilla at baseline, T1,T3 and T6. Normal:Interdental papilla fills embrasure space to the apical extent of the interdental contact point/area. Class-I. The tip of the interdental papilla lies between the interdental contact point and the most coronal extent of the inter proximal CEJ (the cemento-enamel junction) (space present but inter proximal CEJ is not visible) Class-II.The tip of the interdental papilla lies at or apical to the interproximal CEJ but coronal to the apical extent of the facial CEJ(interproximal CEJ visible) Class-III.The tip of the interdental papilla lies level with or apical to the facial CEJ

  T6: 6th month

• Interdental Tissue Stroke (ITS) (Jemt's classification system)

  The following scores were assigned to the papilla at baseline, T1,T3 and T6. Each interdental papilla was scored as 0-3 based upon Jemt's classification system Score 0: No papilla is present Score 1: Less than half of the height of the papilla is present Score 2: Half or more of the height of the papilla is present Score 3: The papilla fills up the entire proximal space

  baseline

• Interdental Tissue Stroke (ITS) (Jemt's classification system)

  The following scores were assigned to the papilla at baseline, T1,T3 and T6. Each interdental papilla was scored as 0-3 based upon Jemt's classification system Score 0: No papilla is present Score 1: Less than half of the height of the papilla is present Score 2: Half or more of the height of the papilla is present Score 3: The papilla fills up the entire proximal space

  T1:1st month

• Interdental Tissue Stroke (ITS) (Jemt's classification system)

  The following scores were assigned to the papilla at baseline, T1,T3 and T6. Each interdental papilla was scored as 0-3 based upon Jemt's classification system Score 0: No papilla is present Score 1: Less than half of the height of the papilla is present Score 2: Half or more of the height of the papilla is present Score 3: The papilla fills up the entire proximal space

  T3:3rd month

• Interdental Tissue Stroke (ITS) (Jemt's classification system)

  The following scores were assigned to the papilla at baseline, T1,T3 and T6. Each interdental papilla was scored as 0-3 based upon Jemt's classification system Score 0: No papilla is present Score 1: Less than half of the height of the papilla is present Score 2: Half or more of the height of the papilla is present Score 3: The papilla fills up the entire proximal space

  T6: 6th month

• Papilla presence index (PPI) (by Cardaropoli et al.)

  The following scores were assigned to the papilla at baseline, T1,T3 and T6. PPI 1: the papilla is completely present and coronally extends to the contact point to completely fill the interproximal embrasure. PPI 2: the papilla is no longer completely present and lies apical to the contact point. But the interproximal CEJ (iCEJ) is still not visible. PPI 3: the papilla is moved more apical and iCEJ becomes visible. PPI 4: the papilla lies apcal to both iCEJ and buccal CEJ. Each interdental papilla was scored as 1-3 based upon PPI.

  baseline

• Papilla presence index (PPI) (by Cardaropoli et al.)

  The following scores were assigned to the papilla at baseline, T1,T3 and T6. PPI 1: the papilla is completely present and coronally extends to the contact point to completely fill the interproximal embrasure. PPI 2: the papilla is no longer completely present and lies apical to the contact point. But the interproximal CEJ (iCEJ) is still not visible. PPI 3: the papilla is moved more apical and iCEJ becomes visible. PPI 4: the papilla lies apcal to both iCEJ and buccal CEJ. Each interdental papilla was scored as 1-3 based upon PPI.

  T1:1st month

• Papilla presence index (PPI) (by Cardaropoli et al.)

  The following scores were assigned to the papilla at baseline, T1,T3 and T6. PPI 1: the papilla is completely present and coronally extends to the contact point to completely fill the interproximal embrasure. PPI 2: the papilla is no longer completely present and lies apical to the contact point. But the interproximal CEJ (iCEJ) is still not visible. PPI 3: the papilla is moved more apical and iCEJ becomes visible. PPI 4: the papilla lies apcal to both iCEJ and buccal CEJ. Each interdental papilla was scored as 1-3 based upon PPI.

  T3:3rd month

• Papilla presence index (PPI) (by Cardaropoli et al.)

  The following scores were assigned to the papilla at baseline, T1,T3 and T6. PPI 1: the papilla is completely present and coronally extends to the contact point to completely fill the interproximal embrasure. PPI 2: the papilla is no longer completely present and lies apical to the contact point. But the interproximal CEJ (iCEJ) is still not visible. PPI 3: the papilla is moved more apical and iCEJ becomes visible. PPI 4: the papilla lies apcal to both iCEJ and buccal CEJ. Each interdental papilla was scored as 1-3 based upon PPI.

  T6: 6th month

Secondary Outcomes (27)

• Gingival index (GI) ( by Löe & Silness 1963)

  baseline

• Gingival index (GI) ( by Löe & Silness 1963)

  T1:1st month

• Gingival index (GI) ( by Löe & Silness 1963)

  T3:3rd month

• Gingival index (GI) ( by Löe & Silness 1963)

  T6: 6th month

• Gingival recession (GR-mm)

  baseline

Study Arms (2)

Platelet-rich fibrin (PRF)

A total of 28 sites from 12 patients who underwent papilla reconstruction with PRF placed with semilunar incision in the maxillary anterior region were included in PRF group. ( Data of 12 patients were included in the study.)

Other: retrospective data analysis

Connective tissue graft (CTG)

A total of 27 sites from 8 patients who underwent papilla reconstruction with CTG placed with semilunar incision in the maxillary anterior region were included in CTG group. (Data of 8 patients were included in the study.)

Other: retrospective data analysis

Interventions

retrospective data analysis OTHER

The data of the patients who underwent papilla reconstruction surgery by one of the authors (S.O.B.) using semilunar incision with either PRF or CTG in the maxillary anterior teeth were included in the study. All selected patients had consent for using their data.The data of the patients included in the study were analyzed.(Baseline (BL) and follow-up (T1( first month) , T3 (third month), T6 (sixth month)) clinical data including periodontal evaluations (gingival index (GI), plaque index (PI), papillary bleeding index, pocket depth (PD), keratinized tissue width (KTW), gingival recession), papilla-associated recordings (alveolar crest-interdental contact point (AC-IC), alveolar crest-papilla tip (AC-PT), papilla tip-interdental contact point (PT-IC), papilla height loss (PHL), interdental tissue stroke (ITS) and papilla presence index (PPI)) and patient satisfaction were analyzed.)

Connective tissue graft (CTG); Platelet-rich fibrin (PRF)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

In Hacettepe University Periodontology Department (Jun 2016-Feb 2018), 186 patients treated with PR were scanned and the data of 55 sites (27 CTG and 28 PRF) from 20 patients meeting the criteria were included.

You may qualify if:

• All selected patients had consent for using their data.
• The data of the patients who underwent PR surgery by one of the authors (S.O.B.) using SI with either PRF or CTG in the maxillary anterior teeth having contact points,
• at least 2 mm keratinized tissue width (KTW) with probing depth (PD)≤ 3 mm adjacent to the open embrasure were included.
• It was ensured that all baseline (BL) and follow-up data were available and all patients received a comprehensive phase I periodontal treatment prior to the PR procedure.

You may not qualify if:

• the patients with systemic problems,
• having medications known to influence the periodontium
• Using tobacco/alcohol
• The relevant regions did not have endodontic problems/needs, caries and history of periodontal surgery.

Sponsors & Collaborators

• Hacettepe University: lead

Study Sites (1)

Hacettepe University, Faculty of Dentistry, Periodontology Department

Ankara, Sıhhiye, 06230, Turkey (Türkiye)

Location

Related Publications (3)

• Sharma E, Sharma A, Singh K. The role of subepithelial connective tissue graft for reconstruction of interdental papilla: Clinical study. Singapore Dent J. 2017 Dec;38:27-38. doi: 10.1016/j.sdj.2017.05.001.

  PMID: 29229072 BACKGROUND

• Singh D, Jhingran R, Bains VK, Madan R, Srivastava R. Efficacy of Platelet-rich Fibrin in Interdental Papilla Reconstruction as Compared to Connective Tissue Using Microsurgical Approach. Contemp Clin Dent. 2019 Oct-Dec;10(4):643-651. doi: 10.4103/ccd.ccd_936_18.

  PMID: 32792824 BACKGROUND

• Carnio J, Carnio AT. Papilla reconstruction: Interdisciplinary consideration for clinical success. J Esthet Restor Dent. 2018 Nov;30(6):484-491. doi: 10.1111/jerd.12411. Epub 2018 Sep 8.

  PMID: 30195268 BACKGROUND

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Asst.Prof

Study Record Dates

• First Submitted: December 1, 2021
• First Posted: January 26, 2022
• Study Start: September 5, 2018
• Primary Completion: November 1, 2018
• Study Completion: December 18, 2018
• Last Updated: March 7, 2022

Record last verified: 2022-02

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)