1. What data in particular will be shared?
   Response - All of the individual participant data collected during the trial, after de-identification.
   


2. What additional supporting information will be shared?
   Response -  Study Protocol
   Response -  Statistical Analysis Plan
   
   
3. Who will be able to view these files?
   Response - Researchers who provide a methodologically sound proposal.
   


4. For what types of analyses will this data be available?
   Response - To achieve aims in the approved proposal.
   


5. By what mechanism will data be made available?
   Response - Proposals should be directed to [dramrit_thapa@rediffmail.com].
   


6. For how long will this data be available start date provided 22-07-2024 and end date provided 11-07-2024?
   Response - Beginning 3 months and ending 5 years following article publication.
   


7. Any URL or additional information regarding plan/policy for sharing IPD? 
   Additional Information - no

Case Selection: -   It is proposed to select 20 patients from Orthodontic OPD at MDC Jabalpur having bimaxillary protrusion with thin alveolar bone topography on the basis of clinical examination. Pre and post orthodontic treatment CBCT evaluation will be carried out for the presence of dehiscence, fenestration and thin alveolar bone topography.

Inclusion Criteria

          -    Age range from 15 to 40 yrs

-    Good general health.

-       Healthy oral mucosa.

-       No history of TMJ disorders.

-       Severe dentoalveolar maxillary protrusion.

-       Co-operative attitude and high degree of self motivation for treatment.

          Exclusion Criteria

          -    Patients with mutilated dentition.

          -    Patients with debilitating diseases.

          -    Heavy smokers (more than 15 Cigarettes per day).

          -    Patients on radiotherapy.

          -    Patients with complex behavioural problems and known psychological disorders.

Methodology

1. The study protocol will be explained in detail to all the patients and guardians and their consent for participating in the study will be taken on the consent form.
2. Pre-surgical radiographic evaluation will be carried out with panoramic radiographs & lateral cephalograms, as baseline records, followed by CBCT.
3. 0.018 Roth bracket will be bonded on the selected cases. After the therapeutic extraction of the bicuspids, anchorage will be reinforced accordingly. Levelling and alignment will be accomplished with sequential use of 0.16 NiTi, 0.16 steel, 0.016 x 0.022 NiTi, 0.016 x 0.022 posted wires.
4. Patients will be advised to maintain strict oral hygiene measures for the entire duration of fixed mechanotherapy.
5. Patients will undergo basic lab investigation after levelling and alignment. This will include routine haematological examination, urine RE.
6. Patients will be assigned to Group A (Undergoing PAOO) or Group B (Undergoing PAOO with LLLT) with an allocation ratio of 1:1 using a simple randomization technique.
7. They will then be taken up for PAOO or PAOO with LLLT and will be managed with a multidisciplinary approach. This will involve raising a full thickness mucoperiosteal flap both buccally and palatally using sulcular releasing incisions. Selective decortication will be performed in a linear or punctate pattern up to 0.5 mm depth over all the teeth that are to be moved.
8. Adequate bioabsorbable dried freeze decalcified corticocancellous (DFDBA) bone substitute material will be placed over the prepared bone. This bone substitute will enhance lateral alveolar augmentation. After the placement of bone graft, flaps will be repositioned and sutured into place. Afterwards, The LLLT application will be performed by one operator with an output power of 100 mW, dose of 5.0 J/sq.cm, and exposure time of 10s. The tip of the probe will be placed perpendicular to the tissue gently without pressure. Each root will be divided into two halves: cervical and apical. The laser device tip will be applied to the center of each half, perpendicular to the root and in direct contact with the mucosa from both the buccal and palatal sides so that there were four application points for each tooth with an exposure time of 1 minute/tooth in addition to mesial and distal interdental region at mid root level. The laser application will be done on days 3, 7, and 14 after PAOO and every 15 days starting from the second month until the leveling and the alignment stage will be complete. Safety measures for the participants and the operator will be followed. Periapical radiographs will be recorded after 3 months.

  IX.         En masse retraction will be initiated 2 weeks after surgery. Post-operative evaluation will be done by clinical and radiographic examination using CBCT after debonding.

       Evaluation parameters

          The following parameters will be evaluated

           -      Pain perception (using visual analog scale)

           -      Gingival inflammation status (by Gingival Index).

           -      Pre and post treatment measurement of the thickness of labial and lingual bone.

           -    Pre and post treatment dehiscence and fenestration in maxillary anterior region                           by use of CBCT.

           -      Total time taken for closure of extraction space after PAOO and PAOO with                            LLLT application simultaneously.

           -     Pre and post treatment Root resorption.

Scope of the Project: This project will prove to be beneficial for patients with severe proclination of anterior teeth requiring maximum anchorage. Such cases are likely to be predisposed with fenestrations, dehiscence and associated periodontal problems.

As the space closure is achieved in less time, this protocol will prove beneficial in reducing the overall treatment time thereby improve patient compliance. In addition, whether both procedures, i.e., PAOO and LLLT application combined should reduce overall treatment time and post op sequelae significantly is to be evaluated in this study.