Comparison of a blood derived product and a dressing processed from animal skin for treatment of receded gums.
- Conditions
- Medical and Surgical, (2) ICD-10 Condition: K055||Other periodontal diseases,
- Registration Number
- CTRI/2022/02/040385
- Lead Sponsor
- Centre for Dental Education and Research All India Institute of Medical Sciences
- Brief Summary
**Introduction**
Gingival recession (GR) results in the exposure of root due to displacement of soft tissue margin apical to the cementoenamel junction.1The ultimate goal of the root coverage surgery is to achieve complete root coverage of exposed root surface with complete blending of the colour and texture of treated area with adjacent tissues.Among the various periodontal root coverage procedures, coronally advanced flap (CAF), modified coronally advanced flap (mCAF) and tunnel technique have been widely utilized for treating multiple recession type defects.2The adjunct use of connective tissue graft (CTG) with the aforementioned surgical approaches has been found to improve the root coverage outcomes at short- and long-term follow-up periods. 3,4 However, the need of a second surgical site to harvest the graft is invariably associated with postsurgical morbidity in terms of pain, bleeding, necrosis of the palatal flap and delayed healing. 5To overcome these disadvantages, clinicians have consistently reported successful use of biomaterials such as acellular dermal matrix (ADM),6 platelet rich fibrin(PRF),7enamel matrix derivatives 8 and collagen matrices (CM) 9as an adjunct to flap only procedures and compared the outcomes with CTG.10-13 Treatment of recession defects with ADM or CM is associated with higher cost of the procedure and may raise the issues of disease transmission and religious reluctance to the use of such biomaterials in some individuals. It may be assumed that PRF can be a viable alternative to the use of CM or ADM. However, there is no study in the literature comparing the root coverage outcomes of PRF versus CM in multiple recession defects. The aim of the present study is therefore to compare the clinical and aesthetic outcomes of PRF or CM in combination with mCAF for the treatment of multiple RT1defects. It is hypothesized that there are no statistical differences for the evaluated parameters at recession sites treated with two (mCAF + PRF versus mCAF + CM) approaches.
***Parameters to be recorded:***
Recession depth (RD), Recession width (RW), Keratinized tissue width (KTW), Probing depth (PD), Clinical attachment level (CAL), Gingival thickness (GT) will be recorded at baseline and at 3-months, 6-months and 1 year follow-up visits by a single blinded examiner on the mid-buccal aspect of teeth to be treated using a manual probe (UNC-15), rounded up to nearest millimetre.
Patient-centered outcome in terms of postsurgical pain, dentinal hypersensitivity and aesthetic satisfaction will be evaluated
**Surgical procedure:**
Modified coronally advanced flap with CM or PRF will be performed for root coverage in all the patients. At the end of the surgery, each patient will be given a non-steroidal anti-inflammatory analgesic, antibiotic, 0.12% chlorhexidine gluconate. postoperative instructions will be given and recalled at 3,6 and 12 months after surgery.
**References:**
1. Wennström JL. Mucogingival therapy. Ann Periodontol. 1996;1:671-701
2. Graziani F, Gennai S, Roldan S, et al. Efficacy of periodontal plastic procedures in the treatment of multiple gingival recessions. J Clin Periodontol. 2014;41:S63–S76
3. Pini-Prato GP, Cairo F, Nieri M, et al. Coronally advanced flap versus connective tissue graft in the treatment of multiple gingival recessions: a split-mouth study with a 5-year follow-up. J Clin Periodontol. 2010;37:644-650.
4. Zucchelli G, Mounssif I, Mazzotti C, et al. Coronally advanced flap with and without connective tissue graft for the treatment of multiple gingival recessions: a comparative short- and long-term controlled randomized clinical trial. J Clin Periodontol. 2014;41:396–403.
5. Chambrone L, Chambrone D, Pustiglioni FE, Chambrone LA,Lima LA. Can subepithelial connective tissue grafts be considered the gold standard procedure in the treatment of Miller Class I and II recession-type defects?. J Dent. 2008; 36: 659-71
6. Ahmedbeyli C, Ipci SD, Cakar G, Kuru BE, Yılmaz S. Clinical evaluation of coronally advanced flap with or without acellular dermal matrix graft on complete defect coverage for the treatment of multiple gingival recessions with thin tissue biotype. J Clin Periodontol. 2014;41:303-10.
7. Aroca S, Keglevich T, Barbieri B, Gera I, Etienne D. Clinical evaluation of a modified coronally advanced flap alone or in combination with a platelet-rich fibrin membrane for the treatment of adjacent multiple gingival recessions: a 6-month study. J Periodontol. 2009;80:244–252.
8. Cordaro L, di Torresanto VM, Torsello F. Split-mouth comparison of a coronally advanced flap with or without enamel matrix derivative for coverage of multiple gingival recession defects: 6- and 24-month follow-up. Int J Periodontics Restorative Dent. 2012;32:e10-20.
9. Cardaropoli D, Tamagnone L, Roffredo A, Gaveglio L. Coronally advanced flap with and without a xenogenic collagen matrix in the treatment of multiple recessions: a randomized controlled clinical study. Int J Periodontics Restorative Dent. 2014;34:s97-102. 20.
10. Harris RJ. A comparative study of root coverage obtained with an acellular dermal matrix versus a connective tissue graft: results of 107 recession defects in 50 consecutively treated patients. Int J Periodontics Restorative Dent. 2000 ;20:51-9.
11. Öncü E. The Use of Platelet-Rich Fibrin Versus Subepithelial Connective Tissue Graft in Treatment of Multiple Gingival Recessions: A Randomized Clinical Trial. Int J Periodontics Restorative Dent. 2017;37:265-271.
12. Alexiou A, Vouros I, Menexes G, Konstantinidis A. Comparison of enamel matrix derivative (Emdogain) and subepithelial connective tissue graft for root coverage in patients with multiple gingival recession defects: A randomized controlled clinical study. Quintessence Int. 2017;48:381-389.
13. Tonetti MS, Cortellini P, Pellegrini G, Nieri M, Bonaccini D, Allegri M, et al. Xenogenic collagen matrix or autologous connective tissue graft as adjunct to coronally advanced flaps for coverage of multiple adjacent gingival recession: Randomized trial assessing non-inferiority in root coverage and superiority in oral health-related quality of life. J Clin Periodontol. 2018;45:78-88.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Not Yet Recruiting
- Sex
- All
- Target Recruitment
- 20
- a)systemically healthy individuals b)Healthy periodontium or demonstrating stable periodontal condition following conventional periodontal therapy c)Full mouth plaque score (FMPS) and full mouth bleeding score (FMBS) of < 15% d)No history of previous periodontal surgery at experimental sites e)Presence of at least two adjacent Cairo RT1 (gingival recession with no loss of interproximal attachment) multiple buccal recessions ≥ 2 mm on anterior teeth or premolars in both jaws f)Presence of an identifiable CEJ (a step ≤1 mm at CEJ level and/or presence of a root abrasion, but with an identifiable CEJ, will be accepted).
- g)Probing depth (PD) ≤ 3 mm h)Absence of non-vital, supraerupted or mobile teeth for treatment of GR.
- a)Molars and teeth with presence of restorations, caries or crowns in the area to be treated.
- b)Gingival recessions presenting minimal amount (<1 mm) of keratinized tissue (KT) apical to recession area.
- c)Pregnant and lactating females d)Smokers or tobacco usage in any form e)History of any systemic medication in last 3 months f)Patients with coagulation disorders.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method To compare and evaluate effectiveness of xenogeneic collagen matrix or platelet rich fibrin with modified coronally advanced flap procedure in terms of 3, 6 months and 1 year gingival recession reduction and soft tissue thickness gain after either treatment. 3, 6 months and 1 year
- Secondary Outcome Measures
Name Time Method Objective assessment of aesthetic outcome using root coverage esthetic score (RES) To assess any differences in patient- centered outcome in terms of postsurgical pain till 1 week and dentinal hypersensitivity and aesthetic satisfaction.
Related Research Topics
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Trial Locations
- Locations (1)
All india institute of medical sciences, New Delhi
🇮🇳West, DELHI, India
All india institute of medical sciences, New Delhi🇮🇳West, DELHI, IndiaDr Vikender YadavPrincipal investigator8800798248vikenderyadav@gmail.com