Influence of Z Shaped and Conventional Sulcular Incisions on Healing and Interproximal Bone Loss in Implant Surgery

NCT04195841 | Unknown

• 1 other identifier: 02_D012_91553
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

The present study is a human, prospective, parallel, randomised controlled clinical trial conducted to check the interproximal bone loss of Z shaped incision over conventional sulcular H shaped incision.The trial is in accordance with the Consolidated Standards of Reporting Trials (CONSORT) criteria, 2010.

Conditions

Bone Loss; Healing Surgical Wounds

Keywords

implant incisions; bone loss; Z shaped incision

Outcome Measures

Primary Outcomes (2)

• Inter proximal bone level

  Mesial and distal peri-implant radiographic bone level will be recorded in millimetres on the digital radiographs with grid at baseline and follow up

  6 months

• Healing

  Early wound healing index is assessed. values 1-5 is present. Increase in score depicts worse healing.

  7 days

Secondary Outcomes (2)

• Visual Analouge Score

  7 days

• Clinical attachment level

  3 months

Study Arms (2)

Test group

EXPERIMENTAL

Two horizontal incisions placed 1-2 mm away from the papilla of the teeth adjacent to the edentulous space following the mesial and distal contour of the teeth. These two horizontal incisions are then connected by an oblique incision from the disto-buccal to mesio lingual point angles.

Procedure: Z shaped incision

Control group

EXPERIMENTAL

Sulcular incisions placed in the proximal sides of the adjacent tooth facing the edentulous space in a bucco lingual direction extending between the proximal line angles Mid crestal incision performed in the attached mucosa of the edentulous area connecting the sulcular incisions of the adjacent teeth from the distal to mesial tooth

Procedure: H shaped incision

Interventions

Z shaped incision PROCEDURE

After local anaesthesia, a mucoperiosteal flap will be elevated at the edentulous ridge with two horizontal incisions placed with a no MB 69 blade, 1-2 mm away from the papilla of the teeth adjacent to the edentulous space following the mesial and distal contour of the teeth. The extend of the incisions should be up to the proximal line angles of the adjacent teeth. These two horizontal incisions are then connected by an oblique incision from the disto-buccal to mesio lingual point angles. A periosteal elevator is used to elevate a full thickness mucoperiosteal flap buccally and lingually to the level of the mucogingival junction, exposing the alveolar ridge of the implant surgical sites. Endosseous implant placement is done followed by simple interrupted resorbable sutures

Test group

H shaped incision PROCEDURE

After local anaesthesia, a mucoperiosteal flap is elelevated by placing sulcular incisions placed in the proximal sides of the adjacent tooth facing the edentulous space in a bucco lingual direction extending between the proximal line angles using a MB 69 blade. Mid crestal incision performed in the attached mucosa of the edentulous area connecting the sulcular incisions of the adjacent teeth from the distal to mesial tooth. A full thickness mucoperiosteal flap will be elevated buccally and lingually to the level of the mucogingival junction to expose the alveolar ridge of the implant surgical sites using a periosteal elevator. Endosseous implant will be placed, followed by simple interrupted resorbable sutures.

Control group

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with single or multiple edentulous spaces in the maxillary and mandibular arches having Siebert's Class 1 and 2 ridge defects.
• Patients willing to participate in the study.
• Patients above 18 years of age.
• Patients exhibiting keratinized tissue width more than or equal to 2 mm.
• Systemically healthy patients.
• Patients who demonstrate full mouth plaque control and bleeding scores\<25% and showing good compliance.

You may not qualify if:

• Patients who do not give consent.
• Untreated periodontal disease, caries.
• Insufficient oral hygiene.
• Smokers.
• Previous radiation therapy.
• Patients with known systemic diseases and conditions
• Pregnant and lactating women.

Sponsors & Collaborators

• Krishnadevaraya College of Dental Sciences & Hospital: lead

Study Sites (1)

Krishnadevaraya college of dental sciences

Bangalore, Karnataka, 562157, India

Location

MeSH Terms

Conditions

Bone Diseases, Metabolic

Condition Hierarchy (Ancestors)

Bone Diseases; Musculoskeletal Diseases; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Officials

• Dr Shobith S Mampuzha, MDS

  Rajiv Gandhi University of Health Sciences

  PRINCIPAL INVESTIGATOR

• Dr Prabhuji MLV, MDS

  Rajiv Gandhi University of Health Sciences

  PRINCIPAL INVESTIGATOR

Study Design

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

Model Details: Two groups were made one test and control. All the subjects required rehabilitation with implants.In the test group Z shaped incision was placed. in control group sulcular H shaped incision was placed.

Study Record Dates

• First Submitted: December 10, 2019
• First Posted: December 12, 2019
• Study Start: November 20, 2018
• Primary Completion: December 31, 2020
• Study Completion: January 1, 2021
• Last Updated: January 5, 2021

Record last verified: 2021-01

Locations

IN (1)