MedPath

To compare the amount of root coverage in receded gums after using two different materials

Phase 3
Completed
Conditions
Gingival recession,
Registration Number
CTRI/2024/07/069807
Lead Sponsor
Vinitha V
Brief Summary

A randomized split mouth study will be conducted for a duration of 18 months for the treatment of Miller s class I and class II gingival recession cases. The randomization will be based on coin toss method. The control site will be treated with sub epithelial connective tissue graft, whereas the test site will be treated with xenogenic collagen matrix. Coronally advanced flap technique will be used for placing both the materials.The primary outcome of this study is to evaluate the amount of root coverage. The secondary outcome is to evaluate the long term success , including other parameters like recession depth, probing pocket depth, recession width and keratinized tissue thickness.The duration for the evaluation of these parameters are 0,3 months and 6 months.Interms of traditional measures of root coverage, at 3 months, XCM+CAF achieved 97.35± 7.52PRC, compared to 95.88 ± 9.23 PRC for CTG+CAF and at 6months, 100 % was achieved respectively. Thus, CM+CAF presents an intriguingcomparison to the traditional CTG gold standard, in terms of colour matching,texture and healing.Theprincipal findings of the present study were reduction in RW, RD, PPD, RAL andVAS score, gain in KTH, KTT and PRC in both the groups after 3 and 6 months. RCESwas not significant in XCM and SCTG group. Time take for surgery and painperception after surgery were less in XCM group as compared to SCTG group.

Detailed Description

Not available

Recruitment & Eligibility

Status
Completed
Sex
All
Target Recruitment
20
Inclusion Criteria

1 Patients with age of ≥18 years 2 Patients have to display at least one buccal recession(bilaterally) classified as Miller s class I or II with no visible loss of interdental hard and soft tissues 3 Probing pocket depth <3mm 4 No prior history of any surgical procedures on the site to be treated 5 Presence of detectable CEJ 6 Systemically healthy subjects with no contraindication to periodontal surgery 7 Able to achieve good oral hygiene and control gingivitis in the whole of the dentition 8 Patient willing to undergo surgical procedure with written informed consent 9 No permanent medication in the last 6 months.

Exclusion Criteria

1 Persistence of uncorrected gingival trauma from tooth brushing 2 Presence of severe tooth malposition rotation or clinically significant supra-eruption 3 Cervical or root caries cervical abrasion prosthetic crown and restorations involving cemento-enamel junction 4 Pregnant and lactating mothers 5 Hypersensitivity or allergy to the collagen based medical product 6 Patients using smoked and smokeless form of tobacco for atleast 6 months.

Study & Design

Study Type
Interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Is to evaluate the amount of root coverage using sub epithelial connective tissue graft and xenogeneic collagen matrix at 3 and 6 months3 months and 6 months
Secondary Outcome Measures
NameTimeMethod
Patients will be evaluated for recession width keratinized tissue thickness keratinized tissue heightone year

Trial Locations

Locations (1)

Government dental college and hospital

🇮🇳

Raipur, CHHATTISGARH, India

Government dental college and hospital
🇮🇳Raipur, CHHATTISGARH, India
Dr Vinitha V
Principal investigator
9791305137
vinithabds28@gmail.com

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