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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

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:

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.

Sites / Locations

Krishnadevaraya college of dental sciences

Arms of the Study

Arm 1

Arm 2

Arm Type

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

NCT ID

NCT04195841

First Posted

December 10, 2019

Last Updated

January 1, 2021

Sponsor

Krishnadevaraya College of Dental Sciences & Hospital

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

Studies a U.S. FDA-regulated Device Product

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

Arm Title

Control group

Arm Type

Experimental

Arm Description

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

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

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

Learn more about this trial

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

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