The Laterally Closed Tunnel Versus Modified Coronally Advanced Tunnel for Mandibular Anterior Gingival Recession Defects

NCT04198376 | Completed

• 1 other identifier: 02_D012_91555
• Study Type: interventional
• Target: 26
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of this study is to comparatively evaluate the advantages of LCT with SCTG over MCAT with SCTG for coverage of deep isolated mandibular anterior recession.

Conditions

Gingival Recession, Localized

Outcome Measures

Primary Outcomes (1)

• Gingival Recession Depth (RD)

  measured as the distance from the CEJ to the gingival margin.

  6 Months

Secondary Outcomes (11)

• Complete Root Coverage (CRC).

  6 Months

• Mean Root Coverage (MRC)

  6 Months

• Gingival Biotype Thickness

  6 Months

• Apico-coronal Width of Keratinized Tissue (KTW)

  6 Months

• Root coverage Esthetic Score (RES)

  6 Months

Study Arms (2)

The Laterally Closed Tunnel Technique with SCTG

EXPERIMENTAL

Following the administration of local anaesthesia 2% lignocaine hydrochloride.In the LCT technique a bevelled intrasulcular incisions will be made around the necks of the affected teeth with Orban Knife.The tunnelling will be accomplished with tunneling instrument (TKN2).A mucoperiosteal tunnel will be prepared using a specially designed tunneling instrument.The muscle and collagen fibres will be released using surgical blades and gracey curettes. Subepithelial CTG will be harvested from palate using single incision technique.The graft will be removed and will be placed on saline soaked gauze and kept wet until its transfer to the recipient bed.An immediate closure of the donor site is performed using modified mattress sutures.The graft will be adapted to the CEJ by means of sling suture.Finally the margins of the pouch will be pulled together over the graft and sutured with interrupted sutures

Procedure: Group A The Laterally Closed Tunnel Technique with SCTG

Modified Coronally Advanced Tunnel Technique with SCTG.

EXPERIMENTAL

In MCAT technique all the buccal tissues will be undermined and connected only the papillary region will be left attached.A full thickness preparation of the papillary region will be created this will be done with a small elevator .A second surgical site will be prepared to obtain the subepithelial CTG using single incision technique.A support suture will be performed to guide the CTG into the recipient site. After sutures are slid through each tunnelled interdental area the needle will be pushed through the CTG before it is guided back through the undermined tissues.The graft will be gently pushed into the pouch with a packing instrument and by pulling the support suture.The entire gingival papillary complex will be moved coronally using a vertical mattress suture anchored in the lingual gingiva.The anchorage in the lingual gingiva will be placed far apically.The suture must capture the buccal flap and graft to avail optimal stabilization.

Procedure: Group B Modified Coronally Advanced Tunnel Technique with SCTG.

Interventions

Group A The Laterally Closed Tunnel Technique with SCTG PROCEDURE

Following the administration of local anaesthesia 2% lignocaine hydrochloride.In the LCT technique a bevelled intrasulcular incisions will be made around the necks of the affected teeth with Orban Knife.The tunnelling will be accomplished with tunneling instrument (TKN2).A mucoperiosteal tunnel will be prepared using a specially designed tunneling instrument.The muscle and collagen fibres will be released using surgical blades and gracey curettes.Subepithelial CTG will be harvested from palate using single incision technique.The graft will be removed and will be placed on saline soaked gauze and kept wet until its transfer to the recipient bed.An immediate closure of the donor site is performed using modified mattress sutures.The graft will be adapted to the CEJ by means of sling suture.Finally the margins of the pouch will be pulled together over the graft and sutured with interrupted sutures.The surgical sites will be protected with a non eugenol periodontal dressing.

The Laterally Closed Tunnel Technique with SCTG

Group B Modified Coronally Advanced Tunnel Technique with SCTG. PROCEDURE

In MCAT technique all the buccal tissues will be undermined and connected only the papillary region will be left attached.A full thickness preparation of the papillary region will be created this will be done with a small elevator.A second surgical site to obtain the subepithelial CTG using single incision technique.A support suture will be performed to guide the CTG into the recipient site.The graft will be gently pushed into the pouch with a packing instrument and by pulling the support suture.The entire gingivopapillary complex will be moved coronally using a vertical mattress suture anchored in the lingual gingiva.The anchorage in the lingual gingiva will be placed far apically.The suture must capture the buccal flap and graft to avail optimal stabilization.The surgical sites will be protected with a non eugenol periodontal dressing.

Modified Coronally Advanced Tunnel Technique with SCTG.

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Isolated Miller's class I, II, III or combined recession defects in mandibular arch.
• Age \>/= 18 years.
• Patients with healthy or treated periodontal conditions.
• Patients willing to participate in the study.
• Absence of uncontrolled medical conditions.
• Full mouth plaque score \</= 10%(O'Leary 1972).
• Full mouth bleeding score \<10%(Ainamo and Bay 1975).
• Patients with esthetic concerns.

You may not qualify if:

• Pregnant or lactating females.
• Tobacco smoking.
• Uncontrolled medical conditions.
• Untreated periodontal conditions.
• Use of systemic antibiotics in the past 3 months.
• Patients treated with any medication known to cause gingival hyperplasia.
• Drug and alcohol abuse.
• No occlusal interferences.

Sponsors & Collaborators

• Krishnadevaraya College of Dental Sciences & Hospital: lead

Study Sites (1)

Krishnadevaraya college of dental sciences

Bangalore, Karantaka, 562157, India

Location

MeSH Terms

Conditions

Gingival Recession

Condition Hierarchy (Ancestors)

Gingival Diseases; Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases; Periodontal Atrophy

Study Officials

• Dr.Phebie Asta Rodrigues, MDS

  Rajiv Gandhi University of Health Sciences

  PRINCIPAL INVESTIGATOR

• Dr.Joann Pauline George, MDS

  Rajiv Gandhi University of Health Sciences

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: The patients will be assigned into two treatment groups Group A (Test Group) comprises of patient undergoing The Laterally Closed Tunnel Technique with SCTG and Group B(Control Group) comprises of patients undergoing Modified Coronally Advanced Tunnel Technique with SCTG

Study Record Dates

• First Submitted: December 12, 2019
• First Posted: December 13, 2019
• Study Start: January 20, 2020
• Primary Completion: December 31, 2020
• Study Completion: January 1, 2021
• Last Updated: November 4, 2022

Record last verified: 2022-11

Data Sharing

• IPD Sharing: Will not share

Locations

IN (1)