Comparing the Secondary Stability of Dental Implants: Immediate Gradual Loading Versus Early Loading Protocol in Posterior Maxilla

Study Overview
=================
Brief Summary
-----------------
The aim of this split mouth study is to compare which method is better in reducing bone loss and healing times following implants. Specifically, the two methods investigated will be immediate gradual loading and early loading protocol. Research Hypothesis Immediate gradual loading using gingival formers is superior to early loading protocols in improving bone quality and thus reducing the healing time.

Detailed Description
-----------------
These two methods (gradual loading and early loading) will both be used in implants patients with the aim to compare which protocol leads to a better outcome for the patient. A 'better outcome' is defined as the method, which leads to the least crestal bone loss, and the fastest healing time. Immediate gradually loaded side: will include transmucosal healing of dental implants using gingival formers which will be replaced every 2 weeks by consequent larger size gingival former.i.e. at surgery time the implants will receive 2 mm height gingival former which will be swapped by 3 mm, 4 mm, 5 mm and the last is 6 mm early loaded side: implants will be submerged from the surgery time till loading time (2 month).

Official Title
-----------------
Split Mouth Clinical Study to Compare the Secondary Stability of Dental Implants Using Immediate Gradual Loading Versus Early Loading Protocol in Posterior Maxilla. A Randomized Controlled Trial

Conditions
-----------------
Dental Implant, Transmucosal Healing, Bone Loss

Intervention / Treatment
-----------------
* Procedure: immediate progressive loading using gingival formers
* Procedure: submerged healing


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion criteria Patients with bilateral Partial or complete edentulous areas in maxillary premolar/molar region. Free medical history. Enough bone quantity. Enough keratinized mucosa Exclusion criteria Systemic disease. Irradiated bone (radiotherapy). Heavy smoking habit. Patients undergoing long-term immunosuppressive therapy. Atrophic ridges. Presence of any local bony lesion. Presence of mandibular parafunctional habits

Ages Eligible for Study
-----------------
Minimum Age: 25 Years
Maximum Age: 55 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: implant A<br>will include implants with immediate progressive loading using gingival formers of different sizes | Procedure: immediate progressive loading using gingival formers<br>* Implant placement will be 1 mm subcrestally, and it will receive transmucosal healing using gingival former. The gingival former will be replaced every 2 weeks by consequent larger size gingival former (at surgery time group A will receive 2 mm height gingival former which will be swapped by,3 mm, 4 mm and the last is 5 mm).<br>|
| Other: implant B<br>The implants will remain submerged from surgery time till loading time 2 month.(submerged healing) | Procedure: submerged healing<br>* the implant placement will be 1 mm subcrestally, and it will receive unloaded healing.(submerged healing)<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| secondary stability of dental implant (ISQ Osstell Mentol) | ISQ Osstell Mentol | 2 month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Bone loss using Periapical Radiographic (Long Cone Paralleling technique) | using Periapical Radiographic (Long Cone Paralleling technique) | 2 month | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
immediate gradual loading