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

Influence of Z Shaped Incisions on Healing and Interproximal Bone Loss in Comparison With Conventional Sulcular Incisions (H Shaped) in Implant Surgery Under Magnification: A Randomized Clinical Trial

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.

Study Overview

• Status: Unknown
• Conditions: Bone Loss; Healing Surgical Wounds
• Intervention / Treatment: Procedure: Z shaped incision; Procedure: H shaped incision

Detailed Description

Twenty healthy individuals satisfying the inclusion and exclusion criteria were recruited for the study. A detailed, thorough medical and dental history was obtained and each patient was subjected to comprehensive clinical and radiological examination. All patients were informed about the nature of the study, the surgical procedure involved, potential benefits and risks associated with the surgical procedure and written informed consent were obtained from all patients. In the test group patients Z shaped incision was done to place implants and H shaped sulcular incision was placed in control group.

The clinical and radiographic parameters were recorded at baseline,24 hours,7days, three months and six months postoperatively.

• Study Type: Interventional
• Enrollment (Actual): 20
• Phase: Not Applicable

Contacts and Locations

Study Locations

• India
  • Karnataka
    • Bangalore, Karnataka, India, 562157
      • Krishnadevaraya college of dental sciences

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

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

Exclusion Criteria:

1. Patients who do not give consent.
2. Untreated periodontal disease, caries.
3. Insufficient oral hygiene.
4. Smokers.
5. Previous radiation therapy.
6. Patients with known systemic diseases and conditions
7. Pregnant and lactating women.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Test group; 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; 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
Experimental: Control group; 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; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Visual Analouge Score	a questionnaire will be given to the patients in which their responses for Visual Analog Score that ranges from 1-10 values and highest values indicate the worst outcome, variation in feeding habits, analgesics dosage is recorded.	7 days
Clinical attachment level	The amount of attached gingiva was measured by subtracting the probing depth from the amount of keratinised mucosa	3 months

Collaborators and Investigators

• Sponsor: Krishnadevaraya College of Dental Sciences & Hospital
• Investigators: Principal Investigator: Dr Shobith S Mampuzha, MDS, Rajiv Gandhi University of Health Sciences; Principal Investigator: Dr Prabhuji MLV, MDS, Rajiv Gandhi University of Health Sciences

Study record dates

Study Major Dates

• Study Start (Actual): November 20, 2018
• Primary Completion (Actual): December 31, 2020
• Study Completion (Anticipated): January 1, 2021

Study Registration Dates

• First Submitted: December 10, 2019
• First Submitted That Met QC Criteria: December 10, 2019
• First Posted (Actual): December 12, 2019

Study Record Updates

• Last Update Posted (Actual): January 5, 2021
• Last Update Submitted That Met QC Criteria: January 1, 2021
• Last Verified: January 1, 2021

More Information

Terms related to this study

• Keywords: bone loss; implant incisions; Z shaped incision
• Additional Relevant MeSH Terms: Metabolic Diseases; Wounds and Injuries; Musculoskeletal Diseases; Bone Diseases; Surgical Wound; Bone Diseases, Metabolic
• Other Study ID Numbers: 02_D012_91553

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No