Treatment of receding gums using two different material.

Not yet recruiting

Conditions: gingival recession

Registration Number: CTRI/2022/11/047783

Lead Sponsor: other

Brief Summary: There are various surgical techniques and their modifications for the treatment of gingival recession. These include pedicle grafts (lateral sliding or double papillae) with or without connective tissue grafts, epithelised autogenous grafts (free gingival), sub-epithelial connective tissue grafts (SCTG), coronally advanced flaps (CAF) alone, CAF preceded by a free gingival graft, and CAF with a simultaneous SCTG.

SCTG helps in improved long-term stability of complete root coverage (CRC) and it is accepted as the gold standard in the treatment of gingival recessions. However, the requirement of a second surgical site, limited amount of graft, rather low patient tolerance and high complication rates in donor area are the major disadvantages of SCTG.

To reduce these disadvantages, barrier membrane, platelet-rich plasma, platelet-rich fibrin, enamel matrix derivatives and graft substitute materials have been used as an alternative to SCTG. But studies have shown that only SCTG in conjunction with CAF was able to enhance the ability to achieve complete root coverage and to improve recession reduction.

Human acellular dermal matrix (ADM) was introduced as SCTG substitute with various surgical techniques aiming root coverage but no additional benefit over CAF+SCTG was found. Additionally, there is a possible risk for disease transmission as it is derived from cadavers which limited the use of this material.

Recently, a new bi-layer xenogeneic collagen matrix (XCM) has been used in periodontal regenerative procedures. XCM is composed of a cell occlusive layer with compact collagen fibre and a spongious layer with porous collagen structure. This porous layer provides stabilization of blood clot and necessary space that helps in cell migration and might increase the formation of keratinized tissue. Hence, XCM seems to be a promising soft tissue graft substitute when used with CAF. It is not only less invasive and time consuming but also provides unlimited off-the-shelf supply of graft material and has been cleared by U S Food and Drug Administration (FDA).

Injectable platelet-rich fibrin (i-PRF) has been produced by changing the type of the tube, centrifugation time and speed; specifically, the blood is centrifuged in plastic tubes at 700 rpm for 3 min (Miron & Choukroun, 2017). I-PRF prepared according to low-speed centrifugation concept can provide a significant advantage for the regeneration process, as it is rich in platelets, leucocytes and growth factors (Choukroun & Ghanaati,2018).

Detailed Description: Not available

Recruitment & Eligibility

Status: Not Yet Recruiting

Sex: All

Target Recruitment: 30

Inclusion Criteria

Patient with age of â‰¥18 years.
Presence of bilateral Millerâ€™s class I (Marginal tissue recession, which does not extend to the mucogingival junction (MGJ)) / class II (Marginal tissue recession extending to or beyond mucogingival junction(MGJ)) gingival recession of same depth on buccal aspect of anterior teeth and premolars with no radiographic sign of bone loss and requiring surgical intervention for root coverage, Probing pocket depth <3mm, No prior history of any surgical procedures on the site to be treated, Presence of detectable CEJ, Not using tobacco in any form, Systemically healthy subjects with no contraindication to periodontal surgery, Able to achieve good oral hygiene and control gingivitis in the whole of the dentition (FMPS<10% and FMBS<10%) Patient willing to undergo surgical procedure and giving written informed consent.

Exclusion Criteria

Not provided

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
modified Coronally advanced tunnel flap with xenogeneic collagen matrix (XCM) and i-prfto be similarly effective as coronally advanced flap with sub-epithelial connective tissue graft (SCTG) in root coverage procedures in terms of recession depth (RD) and percentage root coverage (RC) at baseline, 1 week, 6 months	modified Coronally advanced tunnel flap with xenogeneic collagen matrix (XCM) and i-prfto be similarly effective as coronally advanced flap with sub-epithelial connective tissue graft (SCTG) in root coverage procedures in terms of recession depth (RD) and percentage root coverage (RC) at baseline, 1 week, 6 months.

Secondary Outcome Measures

Name	Time	Method
relative attachment level, keratinized tissue height, keratinized tissue thickness , recession width and root coverage esthetic score in patients treated with XCM and iprf when compared to patients treated with SCTG and XCM only	at 6 months

Trial Locations

Locations (1): bhilai dental clinic
🇮🇳
Durg, CHHATTISGARH, India
bhilai dental clinic
🇮🇳Durg, CHHATTISGARH, India
Dr Supriya Mishra
Principal investigator
8889651606
dr.supriya4@gmail.com