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

Primary Purpose

Bone Loss, Healing Surgical Wounds

Status
Unknown status
Phase
Not Applicable
Locations
India
Study Type
Interventional
Intervention
Z shaped incision
H shaped incision
Sponsored by
Krishnadevaraya College of Dental Sciences & Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Bone Loss focused on measuring implant incisions, bone loss, Z shaped incision

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)Accepts Healthy Volunteers

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.

Sites / Locations

  • Krishnadevaraya college of dental sciences

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Test group

Control group

Arm Description

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.

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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.
Clinical attachment level
The amount of attached gingiva was measured by subtracting the probing depth from the amount of keratinised mucosa

Full Information

First Posted
December 10, 2019
Last Updated
January 1, 2021
Sponsor
Krishnadevaraya College of Dental Sciences & Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT04195841
Brief Title
Influence of Z Shaped and Conventional Sulcular Incisions on Healing and Interproximal Bone Loss in Implant Surgery
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
January 2021
Overall Recruitment Status
Unknown status
Study Start Date
November 20, 2018 (Actual)
Primary Completion Date
December 31, 2020 (Actual)
Study Completion Date
January 1, 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Krishnadevaraya College of Dental Sciences & Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bone Loss, Healing Surgical Wounds
Keywords
implant incisions, bone loss, Z shaped incision

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
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.
Masking
None (Open Label)
Allocation
Randomized
Enrollment
20 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Test group
Arm Type
Experimental
Arm Description
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.
Arm Title
Control group
Arm Type
Experimental
Arm Description
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
Intervention Type
Procedure
Intervention Name(s)
Z shaped incision
Intervention Description
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
Intervention Type
Procedure
Intervention Name(s)
H shaped incision
Intervention Description
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.
Primary Outcome Measure Information:
Title
Inter proximal bone level
Description
Mesial and distal peri-implant radiographic bone level will be recorded in millimetres on the digital radiographs with grid at baseline and follow up
Time Frame
6 months
Title
Healing
Description
Early wound healing index is assessed. values 1-5 is present. Increase in score depicts worse healing.
Time Frame
7 days
Secondary Outcome Measure Information:
Title
Visual Analouge Score
Description
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.
Time Frame
7 days
Title
Clinical attachment level
Description
The amount of attached gingiva was measured by subtracting the probing depth from the amount of keratinised mucosa
Time Frame
3 months

10. Eligibility

Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: 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. Exclusion Criteria: 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dr Shobith S Mampuzha, MDS
Organizational Affiliation
Rajiv Gandhi University of Health Sciences
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Dr Prabhuji MLV, MDS
Organizational Affiliation
Rajiv Gandhi University of Health Sciences
Official's Role
Principal Investigator
Facility Information:
Facility Name
Krishnadevaraya college of dental sciences
City
Bangalore
State/Province
Karnataka
ZIP/Postal Code
562157
Country
India

12. IPD Sharing Statement

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

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