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CTRI Number  CTRI/2023/05/052252 [Registered on: 03/05/2023] Trial Registered Prospectively
Last Modified On: 03/05/2023
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Dentistry 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   Comparison of Peri-Implant Clinical and Radiological Parameters after using Glycine Air Abrasion, Soft Tissue Diode Laser or Titanium Brush adjunctive to Conventional Peri-Implantitis Therapy 
Scientific Title of Study   Comparison of Peri-Implant Clinical and Radiological Parameters after using Glycine Air Abrasion, Soft Tissue Diode Laser or Titanium Brush adjunctive to Conventional Peri-Implantitis Therapy: A Randomized Controlled Clinical and Radiological Trial 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dipanshu Pahuja 
Designation  Post Graduate student 
Affiliation  V.Y.W.S. Dental College and Hopital, Amravati 
Address  V.Y.W.S Dental college and hospital, Amravati
Room no. 16, Department of Periodontology, Tapovan - Wadali road, camp road, SRPF colony, Amravati 444602
Amravati
MAHARASHTRA
444602
India 
Phone  9405978744  
Fax    
Email  dipanshupahuja1@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Simran Parwani 
Designation  HOD and Professor 
Affiliation  V.Y.W.S. Dental College and Hopital, Amravati 
Address  Room no. 16, Department of Periodontology, V.Y.W.S Dental college and hospital, Amravati
Tapowan - Wadali road, camp road, SRPF colony, Amravati 444602
Amravati
MAHARASHTRA
444602
India 
Phone  9977132697  
Fax    
Email  simpar74@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dipanshu Pahuja 
Designation  Post Graduate student 
Affiliation  V.Y.W.S. Dental College and Hopital, Amravati 
Address  Room no. 16, Department Of PEriodontology, V.Y.W.S Dental college and hospital, Amravati
Room no. 16, Department of Periodontology, Tapovan - Wadali road, camp road, SRPF colony, Amravati 444602
Amravati
MAHARASHTRA
444602
India 
Phone  9405978744  
Fax    
Email  dipanshupahuja1@gmail.com  
 
Source of Monetary or Material Support  
V.Y.W.S. Dental College and Hospital, Tapovan-Wadali road, camp road, CRPF colony, Amravati 444602 
 
Primary Sponsor  
Name  Dr Dipanshu Pahuja 
Address  V.Y.W.S. Dental college and Hospital, Amravati 
Type of Sponsor  Other [self sponsored] 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dipanshu Pahuja  V.Y.W.S. Dental College and Hospital, Amravati  Room no. 16, Department of Periodontology,Tapovan - Wadali road, SRPF colony, Camp road , Amravati 444602
Amravati
MAHARASHTRA 		 9405978744

dipanshupahuja1@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee-VYWSDCHA  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: K056||Periodontal disease, unspecified,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Air abrasion  Conventional + Glycine Air Abrasion group), in addition to conventional treatment modality; Air abrasion with amino acid glycine powder will be used for 5 sec. before irrigation; resective or regenerative procedure (as needed) and suturing. A specially designed device (Air Prophy UnitTM) with a tumbler and sleek nozzle will be used for air polishing. The tumbler will carry slurry of glycine powder and water. A circular motion from coronal to apical parallel to the implant surface in a noncontact mode will be applied followed by irrigation with sterile saline (20 ml, 20 seconds) to remove the amino acid glycine powder. A high-speed evacuation system, placed at 5 cm from the air-abrasive nozzle, will be employed to limit powder accumulation and risk of emphysema.. Patients will be assessed for primary and secondary parameters at four timepoints (baseline, three, six and nine months after treatment) 
Intervention  Conventional  (Conventional/Control group), granulation tissue will be entirely removed from the osseous defect and mechanical instrumentation of the implant surface will be achieved with titanium curettes. After instrumentation, thorough cleansing of the implant surface by the use of sterilized gauze squares soaked in saline solution will be used. Surgical resective and/or regenerative techniques will be performed as per CIST protocol.. Patients will be assessed for primary and secondary parameters at four timepoints (baseline, three, six and nine months after treatment) 
Intervention  Laser  (Conventional + Laser group), the conventional procedure will be done along with the additional use of a 10 W, 980 nm soft tissue diode laser to decontaminate the implant surface in pocket sterilization treatment contact mode. Laser irradiation with power of 1 W in pulsed mode will be applied on the implant holding the fiberoptic tip parallel to the degranulated implant surface. Each affected surface will be irradiated three times; for 10 sec. moving from one end and encircling the whole implant keeping in mind that the base of the peri-implant pocket is at least 1 mm from the tip of laser. During this process, the surgeon, the assistant, and the patient should wear special protective glasses for protection against laser beam reflection. The procedure will be performed in an isolated area with warnings of laser use, and no other people will be allowed to access during the procedure for their safety.. Patients will be assessed for primary and secondary parameters at four timepoints (baseline, three, six and nine months after treatment)  
Comparator Agent  NIL  NIL 
Intervention  Titanium Brush  (Conventional + Titanium brush group), decontamination of implant surface will be done by titanium brush along with conventional treatment modality. The brush will be used for approximately 30 s. The brush consists of a stainless-steel shaft and titanium bristles which can be mounted on any low-speed surgical oscillating handpiece (900 oscillations per minute max) in clockwise and counterclockwise directions. The treatment site will be irrigated and cooled with sterile saline (NaCl) externally; if internal irrigation is not available with handpiece. In either case, high speed evacuation will be done in order to avoid the risk of emphysema.. Patients will be assessed for primary and secondary parameters at four timepoints (baseline, three, six and nine months after treatment) 
 
Inclusion Criteria  
Age From  15.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  The patients present with one or more implants showing signs of peri-implantitis with the following conditions will be included in the study:
a. Bleeding/suppuration on probing in peri-implant tissues.
b. PPD ≥ 3 mm around implants.
c. Radiographic evidence of bone loss around implants and/or exposure of implant threads clinically and/or radiographically.
d. No occlusal overload (checked by articulating papers).
 
 
ExclusionCriteria 
Details  a. Acute infection.
b. Medically compromised patients.
c. Uncooperative patients.
d. Heavy smokers.
e. Non-compliant patients for oral hygiene maintenance.
f. Mechanical failure like fixture fracture
g. Habits leading to trauma from occlusion.
h. Complete mobility of the implant or advanced periimplantitis lesion (>6mm/>50% implant length exposed) according to Monje et al.’s classification.7
i. Inflammatory diseases with exaggerated responses like rheumatoid arthritis or granulomatous diseases that might influence treatment outcome.
j. Patients on long term steroids or bisphosphonates therapy.
k. Patient having frank gingivitis or periodontitis in the vicinity of periimplantitis site.
 
 
Method of Generating Random Sequence   Stratified randomization 
Method of Concealment   Case Record Numbers 
Blinding/Masking   Participant and Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
1. Probing pocket depth (PPD)
2. Relative attachment level (RAL)
3. Marginal bone level (MBL)
4. Stability of implant
 		 Baseline, Three months, Six Months and Nine months 
 
Secondary Outcome  
Outcome  TimePoints 
1. Gingivitis Index (Loe H and Silness J,1963)
2. Plaque index (Turesky-Gilmore-Glickman modification of Quigley-Hein Plaque Index,1970)
3. Bleeding on probing
 		 Baseline, Three months, Six Months and Nine months 
 
Target Sample Size   Total Sample Size="36"
Sample Size from India="36" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   N/A 
Date of First Enrollment (India)   15/05/2023 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="1"
Months="8"
Days="0" 
Recruitment Status of Trial (Global)   Not Yet Recruiting 
Recruitment Status of Trial (India)  Open to Recruitment 
Publication Details   none yet 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary   The use of titanium dental implants for reconstructing the lost dentition has demonstrated a high degree of success in achieving osseointegration (97%–98%) and long‐term predictability (survival rates of, approximately, 89% after 10 years of service). In spite of this good prognosis, implant‐related complications, both biological and mechanical, do occur, namely peri‐implant diseases.1 In the 2017 World Workshop on Periodontology, these diseases were classified in two distinct conditions, peri‐implant mucositis defined by the presence of reversible inflammatory changes, as bleeding on gentle probing, erythema, swelling and/or suppuration in the mucosa around an implant and peri‐implantitis, defined as a biofilm‐associated pathological condition occurring in tissues around dental implants, characterized by inflammation in the peri‐implant mucosa and subsequent progressive loss of supporting bone.

Toma et al4 evaluated and compared the efficacy of three mechanical procedures for surgically treating peri-implantitis and they concluded that the titanium brush and glycine air-polishing device were more effective than the other methods.
Furthermore, Renverts et al.5 conducted the study and compared the treatment effects between air-abrasive (AM) and Er:YAG laser (LM) mono-therapy in cases with severe peri-implantitis. de Tapia et al.1 also compared and evaluated an additional mechanical approach, a titanium brush, in the implant surface decontamination performed during the regenerative surgical therapy of peri‐implantitis. But presently there is only few studies reported in literature comparing all these three treatment modalities of periimplantitis. Hence, the aim of present study is to compare clinical and radiological parameters after using glycine air abrasion, soft tissue diode laser or titanium brush adjunctive to conventional peri-implantitis therapy.
 
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