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Status unknownNCT04195841Updated Jan 5, 2021

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

An interventional study of Z shaped incision and H shaped incision in Bone Loss and Healing Surgical Wounds, sponsored by Krishnadevaraya College of Dental Sciences & Hospital. Status unknown at 1 site in India. Per ClinicalTrials.gov, last updated 2021-01-05.

Sponsored by Krishnadevaraya College of Dental Sciences & Hospital · Not applicable, Interventional, and Prevention

The sponsor has not verified this record recently (last verified Jan 2021), so the status shown — last known as Enrolling by invitation — may be out of date.

From the registry’s dates

  • Registered 1 year after the study started (first participant enrolled Nov 2018, registered Dec 2019).
Phase
Not applicable
Study type
Interventional
Enrollment
20
Allocation
Randomized
01

Study 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.

Read the 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.

02

Conditions studied

  • Bone Loss
  • Healing Surgical Wounds

Keywords

  • implant incisions
  • bone loss
  • Z shaped incision
03

In context

Bone Diseases, Metabolic

470 studies on the registry are indexed under Bone Diseases, Metabolic; 71 are open to participants now.

This study's enrollment of 20 is below the median of 60 across 359 interventional studies indexed under Bone Diseases, Metabolic.

Browse Bone Diseases, Metabolic studies →

Lead sponsor

Krishnadevaraya College of Dental Sciences & Hospital is the lead sponsor of 51 studies on the registry; 13 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Accepts healthy volunteers
Yes

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

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.
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Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
20 participants (actual)

Study arms

  • 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

  • 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

Interventions

  • ProcedureZ 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

  • ProcedureH 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.

06

What researchers measure

Primary outcomes

  1. 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

    Time frame: 6 months

  2. Healing

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

    Time frame: 7 days

Secondary outcomes

  1. 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.

    Time frame: 7 days

  2. Clinical attachment level

    The amount of attached gingiva was measured by subtracting the probing depth from the amount of keratinised mucosa

    Time frame: 3 months

07

Study locations

1 site
  • Krishnadevaraya college of dental sciences
    Bangalore, Karnataka 562157, India
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 5, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT04195841
Lead sponsor
Krishnadevaraya College of Dental Sciences & Hospital
Responsible party
Sponsor
First posted
Dec 12, 2019
Start date
Nov 20, 2018
Primary completion
Dec 31, 2020
Completion
Jan 1, 2021 (estimated)
Last update
Jan 5, 2021

Study contacts

Dr Shobith S Mampuzha, MDS
principal investigator · Rajiv Gandhi University of Health Sciences
Dr Prabhuji MLV, MDS
principal investigator · Rajiv Gandhi University of Health Sciences

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is status unknown, as verified in Jan 2021. You cannot join it, but the record below documents what was studied.

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