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

Completed

• Conditions: To Evaluate the Efficacy of Connective Tissue Graft in Papilla Reconstruction; To Evaluate the Efficacy of Platelet-rich Fibrin in Papilla Reconstruction
• Interventions: Other: retrospective data analysis

• Registration Number: NCT05207696
• Lead Sponsor: Hacettepe University

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2018-09-05
• Primary Completion: 2018-11-01
• Study Completion: 2018-12-18
• Study First Submitted: 2021-12-01
• Study First Submitted QC: 2022-01-12
• Study First Posted: 2022-01-26
• Status Verified: 2022-02
• Last Update Submitted: 2022-02-18
• Last Update Posted: 2022-03-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 55

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.

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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.

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Platelet-rich fibrin (PRF)	retrospective data analysis	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.)
Connective tissue graft (CTG)	retrospective data analysis	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.)

Primary Outcome Measures

Name	Time	Method
Interdental Tissue Stroke (ITS) (Jemt's classification system)	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)	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.)	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)	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)	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)	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 Outcome Measures

Name	Time	Method
Pocket depth (PD-mm)	T6: 6th month	Periodontal probe was positioned in the gingival sulcus . The distance between the top of the free gingiva and the bottom of the sulcus was reported as PD. (measurements are in millimeters)
Plaque index (PI) (by Silness & Löe 1964 )	T6: 6th month	0- No plaque; 1. -A film of plaque adhering to the free gingival margin and adjacent area of the tooth. The plaque may be seen in situ only after application of disclosing solution or by using the probe on the tooth surface.; 2. -Moderate accumulation of soft deposit s within the gingival pocket, or the tooth and gingival margin which can be seen with the naked eye.; 3. -Abundance of soft matter within the gingival pocket and/or on the tooth and gingival margin.; The PI of the individual can be obtained by adding the values of each tooth and dividing by the number of teeth examined.
Patient-based variables	T6: 6th month	Evaluation was made using the Visual Analog Scale( VAS- 0-10). The experienced pain values, the aesthetic expectations , The gained aesthetics / difficulty variables. these three criteria were evaluated together ( patient satisfaction )
Papillary Bleeding Index(PBI) (by Saxer & Muhlemann 1975)	T6: 6th month	The PBI has proven to be particularly useful for assessing inflammation in the interdental papillae by recording bleeding on probing in the interdental areas during the course of treatment.; Grade 0- no bleeding, normal papilla Grade 1- 20-30 seconds after probing the mesial and distal sulcus with a periodontal probe, a single bleeding point is observed.; Grade 2- A fine line of blood or several bleeding points become visible at the gingival margin.; Grade 3- Triangle The interdental triangle becomes more or less filled with blood Grade 4- Immediately after probing, blood flows into the interdental area to cover portions of the tooth and/or gingiva The PBI is calculated by dividing the bleeding number by the total number of papilla examined.
Gingival recession (GR-mm)	T6: 6th month	The distance between buccal CEJ and the most coronal extent marginal gingiva was reported as GR.; (measurements are in millimeters)
Keratinized tissue width (KTW-mm)	T6: 6th month	It extends from the free gingival margin to the mucogingival junction and consists of the free gingiva as well as the attached gingiva. The distance between the most coronal extent free gingiva in buccal and the most coronal extent mucogingival junction was reported as KTW. (measurements are in millimeters)
Gingival index (GI) ( by Löe & Silness 1963)	T6: 6th month	The Gingival Index (GI) scores each site on a 0 to 3 scale, with 0 being normal and 3 being severe inflammation characterized by edema, redness, swelling, and spontaneous bleeding.; The GI uses the following scoring system: 0 = normal gingiva; 1. = mild inflammation: slight change in color, slight edema, no bleeding on probing; 2. = moderate inflammation: redness, edema, and glazing, or bleeding on probing; 3. = severe inflammation: marked redness and edema, tendency toward spontaneous bleeding, ulceration The GI of the individual can be obtained by adding the values of each tooth and dividing by the number of teeth examined.

Trial Locations

Locations (1)

Hacettepe University, Faculty of Dentistry, Periodontology Department; 🇹🇷 Ankara, Sıhhiye, Turkey