Evaluation of transcrestal maxillary sinus lifting by densah burs and osteotome with simultaneous implant placement - A randomised controlled clinical trial.

RESEARCH QUESTION-

Which amongst the Densah bur and Osteotome for maxillary sinus lift with simultaneous Implant placement is more effective in implant stability and operation time ?

 RESEARCH HYPOTHESIS-

Null hypothesis- : There is no significant difference between using the Densah burs or the osteotome for transcrestal maxillary sinus lifting with simultaneous implant placement regarding  implant stability and operation time.

Alternative hypothesis- There will be difference between surgical outcomes of using the Densah burs or the osteotome for transcrestal maxillary sinus lifting with simultaneous implant placememnt  regarding implant stability and operation time.

 AIM OF THE STUDY:

To compare the treatment outcomes of Densah Burs and Osteotomes for maxillary sinus lift with simultaneous Implant placement in Posterior Maxilla.

 OBJECTIVES

1. To Evaluate the Primary and Secondary Stability of Dental implant after placement by    Densah Bur and Osteotome.

2. To Evaluate the crestal bone loss of Dental Implant by Densah bur and Osteotome.

3. To Evaluate the Time taken for implant placement by Densah Bur and Osteotome.

4. To Evaluate the post operative pain by Densah Bur and Osteotome.

5. To Evaluate the post operative complication by Densah Bur and Osteotome.

 MATERIALS AND METHODS:

The present study will be conducted in the Department Of Periodontology, Rural Dental Hospital, Loni. A total of 15 patients, sample size 30 with missing maxillary premolars or molars and with limited vertical bone height below the maxillary sinus floor (6mm or more) received implants either with osteotome or with osseodensification densah bur  transcrestal sinus lifting.

 STUDY DESIGN:

Study Type : Experimental (Phase 3)

Study Design : Randomized controlled clinical trial

Period of Study : 2 years

Study Start Date : March 2025 (after the IEC approval)

Setting : Department of Periodontology, Rural Dental Hospital, Loni.

 INCLUSION CRITERIA

·  All the patients giving informed consent will be included in the study.

·  Patient with Age group 18-60 years of either sex.

·  Posterior missing teeth and tooth .(Kennedys classification 1,2,3,6)

·  Patient with no history of sinus surgery.

·  Patient with minimal height of 6mm in edentulous area.

·  All types of bone density (D1-D4) based on CBCT.

·  Patients who accepted to come for follow up .

 EXCLUSION CRITERIA

·  Patients undergoing and with history of radiotheraphy.

·  Medically compromised patients.

·  Patient on long term steroid therapy

·  Heavy smokers(more than 20 cigarettes )

·  Restricted mouth opening .

 METHODOLOGY:

All patients satisfying the above inclusion and exclusion criteria will be given a unique code and subjected to a well-defined random allocation method.

Randomization technique: Each eligible patient indicated to undergo the trial will be subjected to random lottery method.

A box will be made containing 15 slips with equal number of right and left sides. Each patient will be asked to pick up a lottery slip from the box. The side picked up by the patient will be taken as Test group-1. This will be done to support randomization.

1. Test group Densah bur Technique

2. Control group OsteotomeTechnique

After selecting the slip, dental implant will be placed accordingly.

 STUDY CONDUCT

All the patients satisfying the above inclusion and exclusion criteria will be grouped into :

Group A: The patients being treated by Densah bur technique with simultaneous implant placement.

Group B: The patients being treated by Osteotome technique with simultaneous implant placement.

 VARIABLES

Sr
No

Measurement of Variable

Measurement scale

Method of Measurement

|1

Age

Ratio scale

Interview/ Records

|2

Gender

Nominal scale

Observations

|3

Primary Stability of Dental Implant

Oridinal scale

Periotest

|4

Secondary Stability of Dental Implant

Ordinal Scale

Periotest

|5

Crestal Bone Loss

Ratio Scale

CBCT

|6

Time taken for Implant placement

Ratio Scale

Interview

|7

Post operative Pain

Ordinal Scale

VAS

|8

Post operative Complications

Ordinal Scale

Clinical evaluation and radiographic diagnosis

  

Sr
No

Measurement Variable

Assessment

|1

Stability of Dental Implant

Periotest

-8 to 0 =good osteointegration

+1 to +9 = Needs clincal examination

+10 to +50 = Osteointegration insufficient

|2

Crestal Bone Loss

CBCT pre operatively

CBCT after 3 months

|3

Time taken for Implant placement

Stopwatch

From first drill to placement of dental implant

  |4

Post operative Pain

Visual Analogue Scale (VAS)

 INITIAL THERAPY:

The information about the need of study will be clarified and a signed informed consent will be taken from patients. Study protocol will be approved by the Institutional Ethical Committee of PIMS (DU) Loni.

In the first visit, full mouth scaling will be undertaken followed by root planing . Plaque control measures will be given to the patient.

 TREATMENT PROCEDURE:

· The implant placement was done by using surgical motor. Before the Implant Osteotomy Procedure started, local anaesthesia containing lignocaine with adrenaline (1:80,000) was injected.The incision was carried out with 15 no blade and mucoperiosteal flap was reflected by giving crestal incision.

· The process of implant osteotomy was started with the pilot drill to accurately reproduce the angulation. A series of drills were used to prepare the osteotomy site precisely and incrementally for an implant. A surgical guide or stent is inserted, checked for proper positioning, and used throughout the procedure to direct the proper implant placement.

· This was followed by using Implant Osteotome and sequential ostetome was done as per required size with the help of mallet and ostetome instrument ,insertion was done .It is important to create a recipient site that is very accurate in size an angulation. It was screwed in and tightened using the implant ratchet provided in the surgical kit. It was made sure that a minimum torque was obtained while screwing in the implant, implant stability was achieved.

· Osseodensification surgical drilling protocol, implant beds will be prepared using specially designed drills (Densah™ burs) that helps to densify bone, as they prepare an osteotomy. Densah burs are specially designed burs that has many lands with a large negative rake angle which works as non-cutting edges to create a layer of compact, dense bone surrounding the wall of the osteotomy. They are marked with laser markings from 8-20 mm depth. Densah burs are designed to have a cutting chisel edge and a tapered shank so as they enter deeper in to the osteotomy, they have a progressively increasing diameter that controls the expansion process. Densah Burs can be used in both Cutting(Clockwise) and Densifying (Anticlockwise) modes within the same procedure. Densah burs are externally irrigated and designed to be used at drill speeds of 800-1500 rpm.

· OD does not excavate bone but simultaneously compacts and autografts the particulate bone thereby preserving vital bone tissue. This is achieved using specialized densifying burs. When these specialized drills are used at high speed in an anticlockwise direction (Densifying mode) with steady external irrigation, the dense compact bone tissue is created along the osteotomy walls. The pumping motion (in and out movement) creates a rate dependent stress to produce a rate dependent strain and allows saline solution to gently pressurize the bone walls.

· Once the implants were inserted, primary implant stability were evaluated by Periotest and the cover screws secured, the surgical sites were thoroughly irrigated with sterile saline to remove debris and clean the wound.

· The time for implant placement was started from the 1st drill (pilot) to implant placement using Digital stop-watch .

· Proper closure of the flap over the implants is essential. Post-surgical intraoral OPG was taken to assess the implant position.

· Standard Post-surgical instructions were delivered and instructions regarding home care and medications were given.

 STUDY PERIOD:

24 months starting from the time of approval of the study.

 ETHICAL APPROVAL:

It will be made clear with the potential subjects that participation will be voluntary and written informed consent will be obtained from those who agree to participate.

 STATISTICAL ANALYSIS:

All the data will be analyzed by applying appropriate tests of significance.

 REFERANCES

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