Clinical trial NCT05207696: Comparison of the Efficacy of Platelet-rich Fibrin and Connective Tissue Graft in Interdental Papilla Reconstruction
Official title: Comparison of the Efficacy of Platelet-rich Fibrin and Connective Tissue Graft in Interdental Papilla Reconstruction: A Retrospective Trial
Study type: OBSERVATIONAL
Overall status: COMPLETED
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
Lead sponsor: Hacettepe University
Sponsor class: OTHER
First posted: 2022-01-26
Enrollment: 55
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: RETROSPECTIVE
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.

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.

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.

Primary outcomes:
measure: Alveolar crest-Interdental contact point (AC-IC mm)
timeFrame: baseline
measure: Alveolar crest-Interdental contact point (AC-IC mm)
timeFrame: T1:1st month
measure: Alveolar crest-Interdental contact point (AC-IC mm)
timeFrame: T3:3rd month
measure: Alveolar crest-Interdental contact point (AC-IC mm)
timeFrame: T6: 6th month
measure: Alveolar crest-Papilla tip (AC-PT mm)
timeFrame: baseline
measure: Alveolar crest-Papilla tip (AC-PT mm)
timeFrame: T1:1st month
measure: Alveolar crest-Papilla tip (AC-PT mm)
timeFrame: T3:3rd month
measure: Alveolar crest-Papilla tip (AC-PT mm)
timeFrame: T6: 6th month
measure: Papilla tip-Interdental contact point (PT-IC mm)
timeFrame: baseline
measure: Papilla tip-Interdental contact point (PT-IC mm)
timeFrame: T1:1st month
measure: Papilla tip-Interdental contact point (PT-IC mm)
timeFrame: T3:3rd month
measure: Papilla tip-Interdental contact point (PT-IC mm)
timeFrame: T6: 6th month
measure: Papilla Height Loss (PHL)(Nordland and Tarnow classification system)
timeFrame: baseline
measure: Papilla Height Loss (PHL)(Nordland and Tarnow classification system)
timeFrame: T1:1st month
measure: Papilla Height Loss (PHL)(Nordland and Tarnow classification system)
timeFrame: T3:3rd month
measure: Papilla Height Loss (PHL)(Nordland and Tarnow classification system)
timeFrame: T6: 6th month
measure: Interdental Tissue Stroke (ITS) (Jemt's classification system)
timeFrame: baseline
measure: Interdental Tissue Stroke (ITS) (Jemt's classification system)
timeFrame: T1:1st month
measure: Interdental Tissue Stroke (ITS) (Jemt's classification system)
timeFrame: T3:3rd month
measure: Interdental Tissue Stroke (ITS) (Jemt's classification system)
timeFrame: T6: 6th month
measure: Papilla presence index (PPI) (by Cardaropoli et al.)
timeFrame: baseline
measure: Papilla presence index (PPI) (by Cardaropoli et al.)
timeFrame: T1:1st month
measure: Papilla presence index (PPI) (by Cardaropoli et al.)
timeFrame: T3:3rd month
measure: Papilla presence index (PPI) (by Cardaropoli et al.)
timeFrame: T6: 6th month
Secondary outcomes:
measure: Gingival index (GI) ( by Löe & Silness 1963)
timeFrame: baseline
measure: Gingival index (GI) ( by Löe & Silness 1963)
timeFrame: T1:1st month
measure: Gingival index (GI) ( by Löe & Silness 1963)
timeFrame: T3:3rd month
measure: Gingival index (GI) ( by Löe & Silness 1963)
timeFrame: T6: 6th month
measure: Gingival recession (GR-mm)
timeFrame: baseline
measure: Gingival recession (GR-mm)
timeFrame: T1:1st month
measure: Gingival recession (GR-mm)
timeFrame: T3:3rd month
measure: Gingival recession (GR-mm)
timeFrame: T6: 6th month
measure: Keratinized tissue width (KTW-mm)
timeFrame: baseline
measure: Keratinized tissue width (KTW-mm)
timeFrame: T1:1st month
measure: Keratinized tissue width (KTW-mm)
timeFrame: T3:3rd month
measure: Keratinized tissue width (KTW-mm)
timeFrame: T6: 6th month
measure: Pocket depth (PD-mm)
timeFrame: baseline
measure: Pocket depth (PD-mm)
timeFrame: T1:1st month
measure: Pocket depth (PD-mm)
timeFrame: T3:3rd month
measure: Pocket depth (PD-mm)
timeFrame: T6: 6th month
measure: Plaque index (PI) (by Silness & Löe 1964 )
timeFrame: baseline
measure: Plaque index (PI) (by Silness & Löe 1964 )
timeFrame: T1:1st month
measure: Plaque index (PI) (by Silness & Löe 1964 )
timeFrame: T3:3rd month
measure: Plaque index (PI) (by Silness & Löe 1964 )
timeFrame: T6: 6th month
measure: Papillary Bleeding Index(PBI) (by Saxer & Muhlemann 1975)
timeFrame: baseline
measure: Papillary Bleeding Index(PBI) (by Saxer & Muhlemann 1975)
timeFrame: T1:1st month
measure: Papillary Bleeding Index(PBI) (by Saxer & Muhlemann 1975)
timeFrame: T3:3rd month
measure: Papillary Bleeding Index(PBI) (by Saxer & Muhlemann 1975)
timeFrame: T6: 6th month
measure: Patient-based variables
timeFrame: T1:1st month
measure: Patient-based variables
timeFrame: T3:3rd month
measure: Patient-based variables
timeFrame: T6: 6th month
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Hacettepe University, Faculty of Dentistry, Periodontology Department
state: Sıhhiye
Study officials:
References:
citation: 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.
citation: 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.
citation: 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.