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Clinical Trials/NCT05207696
NCT05207696
Completed
N/A

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

Hacettepe University1 site in 1 country55 target enrollmentSeptember 5, 2018

Overview

Phase
N/A
Intervention
Not specified
Conditions
To Evaluate the Efficacy of Platelet-rich Fibrin in Papilla Reconstruction
Sponsor
Hacettepe University
Enrollment
55
Locations
1
Primary Endpoint
Interdental Tissue Stroke (ITS) (Jemt's classification system)
Status
Completed
Last Updated
4 years ago

Overview

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.

Detailed Description

PT-IC was taken as the primary outcome measure. Normal distribution was assessed by histogram and Shapiro-Wilk test. Continuous variables were represented as mean±SD whereas the categorical variables were reported as numbers and percentages. Chi-square test was used for the comparison of the categorical variables. Since the data was normally distributed, Friedman test was used to analyze the time-dependent changes in both groups and the inter-group comparisons were made with Mann-Whitney test. Generalized Estimating Equation was used for analyzing qualitative and quantitative data, time-dependent changes, and the difference between two methods. Data analysis was performed in IBM SPSS Statistics Version 23, and p\<0.05 was considered as a significance threshold.

Registry
clinicaltrials.gov
Start Date
September 5, 2018
End Date
December 18, 2018
Last Updated
4 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Selcen Ozcan Bulut

Asst.Prof

Hacettepe University

Eligibility Criteria

Inclusion Criteria

  • 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.

Exclusion Criteria

  • 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.

Outcomes

Primary Outcomes

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

Time Frame: T6: 6th month

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

Alveolar crest-Papilla tip (AC-PT mm)

Time Frame: T6: 6th month

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)

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

Time Frame: T6: 6th month

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.

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

Time Frame: T6: 6th month

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)

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

Time Frame: T6: 6th month

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)

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

Time Frame: T6: 6th month

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

Secondary Outcomes

  • Pocket depth (PD-mm)(T6: 6th month)
  • Plaque index (PI) (by Silness & Löe 1964 )(T6: 6th month)
  • Patient-based variables(T6: 6th month)
  • Papillary Bleeding Index(PBI) (by Saxer & Muhlemann 1975)(T6: 6th month)
  • Gingival recession (GR-mm)(T6: 6th month)
  • Keratinized tissue width (KTW-mm)(T6: 6th month)
  • Gingival index (GI) ( by Löe & Silness 1963)(T6: 6th month)

Study Sites (1)

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