| CTRI Number |
CTRI/2026/04/108328 [Registered on: 13/04/2026] Trial Registered Prospectively |
| Last Modified On: |
14/04/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparison of healing around dental implants when placed using para-crestal incision and when placed using normal mid-crestal incision |
|
Scientific Title of Study
|
Comparative Study of Peri-Implant Tissue Response after Implant Placement Using Para-Crestal versus Mid-Crestal Incision: A Randomized Controlled Trial. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| U1111-1332-8565 |
UTN |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Smriti Mall |
| Designation |
PG Student, Department of Periodontology and Oral Implantology |
| Affiliation |
Uttaranchal Dental And Medical Research Institute |
| Address |
Room No.10,Department of Periodontology and Oral Implantology,Uttaranchal Dental And Medical Research Institute,Mazri Grant,Dehradun,Uttarakhand,India,248140
Dehradun
UTTARANCHAL
248140
India |
| Phone |
7665308778 |
| Fax |
|
| Email |
smritimall29@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Aaron F Gomes |
| Designation |
PG Guide, Professor and Head, Department of Periodontology and Oral Implantology |
| Affiliation |
Uttaranchal Dental and Medical Research Institute |
| Address |
Department of Periodontology and Oral Implantology, Uttaranchal Dental And Medical Research Institute
Mazri Grant
Dehradun Uttarakhand, India
248140
Dehradun
UTTARANCHAL
248140
India |
| Phone |
9860597402 |
| Fax |
|
| Email |
aarongomes@hotmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Smriti Mall |
| Designation |
PG Student, Department of Periodontology and Oral Implantology |
| Affiliation |
Uttaranchal Dental and Medical Research Institute |
| Address |
Room No 10, Department of Periodontology and Oral Implantology, Uttaranchal Dental And Medical Research Institute
Mazri Grant
Dehradun Uttarakhand, India
248140
Dehradun
UTTARANCHAL
248140
India |
| Phone |
7665308778 |
| Fax |
|
| Email |
smritimall29@gmail.com |
|
|
Source of Monetary or Material Support
|
| Uttaranchal Dental and Medical Research Institute,
P.O. Mazri Grat, Taluka Doiwala, District Dehradun, Uttarakhand. India. 248140 |
|
|
Primary Sponsor
|
| Name |
Dr Smriti Mall |
| Address |
Postgraduate student, Room No.10,Department of Periodontology and Oral Implantology,Uttaranchal Dental And Medical Research Institute,Mazri Grant,Dehradun,Uttarakhand,India,248140 |
| Type of Sponsor |
Other [Self] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Smriti Mall |
Uttaranchal Dental and Medical Research Institute |
Room No.10,Department of Periodontology and Oral Implantology,Uttaranchal Dental And Medical Research Institute,Mazri Grant,Dehradun,Uttarakhand,India,248140
Dehradun
UTTARANCHAL |
7665308778
smritimall29@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee,Uttaranchal Dental and Medical Research Institute |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K084||Partial loss of teeth, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Dental implant fixture placement by conventional flap with mid-crestal incision |
Dental implants fixtures shall be placed by conventional raising of mucoperiosteal flap using a mid-crestal incision and thereafter conventional preperation of implant osteotomy of osteotomy with normal saline and conventional fixture insertion. Difference with other group is that the incision for mucoperiosteal flap in edentulous area will be in the middle of alveolar ridge bucco-lingually and within attached mucosa |
| Comparator Agent |
Dental implant fixture placement by flap with para-crestal incision |
Dental implants fixtures shall be placed by raising of mucoperiosteal flap using a para-crestal incision and thereafter conventional preperation of implant osteotomy of osteotomy with normal saline and conventional fixture insertion. Difference with other group is that the incision for mucoperiosteal flap in edentulous area will be away from the middle of alveolar ridge but within attached mucosa. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
Systemically healthy Indian patient,
each an age of at least 18 years; upper age limit 65 years,
partially edentulous,
sufficient bone height/width for implant placement,
ready to come for 6-months recall. |
|
| ExclusionCriteria |
| Details |
Active periodontal infection(no periodontal pocket depth greater than 3mm at the time of implant placement),
unresolved extraction wounds or inadequate bone at the time of implant placement,
need for advanced implant surgical procedures like ridge augmentation, sinus lift augmentation, etc,
lack of motivation and/or compliance,
smokers,
uncontrolled diabetes mellitus,
bruxism,
medical condition that contraindicates surgery,
pregnacy. |
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Early Wound Healing Score (Marini et al., 2018) |
- 7 days after implant placement surgery.
- 1 month after implant placement surgery |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Participant’s Perception of Pain with Universal Pain Assessment Tool |
Baseline
4 days
7 days |
| Peri-implant crestal bone level |
3 months
6 months |
| Peri-implant Radiolucencies |
3 months
6 months |
| modified Plaque Index (Mombeli et al., 1987) |
6 months |
| Peri-implant mucosal index (Apse et al., 1991) |
6 months |
| modified Sulcus Bleeding Index (Mombelli et al., 1987) |
6 months |
| Misch’s Clinical Implant Mobility Scale (Misch, 2008) |
6 months |
| Peri-implant Sulcus Probing Depth |
6 months |
| Peri-implant Clinical Attachment Level |
6 months |
| Peri-implant Mucosal Margin Level |
6 months |
| Width of Peri-implant Keratinized Mucosa |
6 months |
| Peri-implant Suppuration |
6 months |
|
|
Target Sample Size
|
Total Sample Size="20"
Sample Size from India="20"
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)
|
27/04/2026 |
| 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="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - YES
- What data in particular will be shared?
Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).
- What additional supporting information will be shared?
Response - Study Protocol
Response - Statistical Analysis Plan
Response - Informed Consent Form
Response - Clinical Study Report
- Who will be able to view these files?
Response - Researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose.
- For what types of analyses will this data be available?
Response - For individual participant data meta-analysis.
- By what mechanism will data be made available?
Response (Others) - By sending email to periopg.udmri@gmail.com along with their study proposal and ethical committee approval
- For how long will this data be available start date provided 02-01-1970 and end date provided 02-01-1970?
Response - Beginning 9 months and ending 36 months following article publication.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - Nil
|
|
Brief Summary
|
BACKGROUND : Incision design plays an important role in the peri-implant healing and long-term implant success. Existing literature provides limited and inconsistent evidence regarding the superiority of para-crestal versus mid-crestal incision. Most available studies are animal based for short follow-up periods, with few well-designed randomized clinical trials in humans. Previous human studies observed better healing and less pain with para-crestal incisions during early follow-up. Long-term effects on crestal bone levels and peri-implant tissue health remain unclear. Hence, this trial with a follow up period of 6-months, has been designed in an Indian population to evaluate peri-implant crestal bone level changes and the clinical health around dental implants that will be placed by either flap designed with para-crestal incision or with mid-crestal incision. Additionally, the implant fixture placement surgical wound healing will be compared over a follow-up period of 1-month and the participant’s perception of pain will be compared upto 7-days. AIM :To evaluate and compare over a follow-up period of 6 months, peri-implant crestal bone level changes and the clinical response around dental implants that will be placed by either flap designed with a para-crestal incision or with mid-crestal incision. Additionally, to evaluate and compare the implant fixture placement surgical wound healing over a follow-up period of 1 month and the participant’s perception of pain until 7-days after surgery. MATERIAL AND METHOD : A Randomized Controlled Trial of 20 participants who are presenting with partially edentulous and systemically healthy will be selected from out-patients visiting the department and an informed consent will be administered.The participants will be randomized into two groups, one is test group (n=10) in which we will placed implants after flap designed with para- crestal incision and other is controlled group (n=10) in which we will placed implants after flap designed with mid- crestal incision. Follow- up and data collection will be done at Baseline (1/2 hour), 4 days, 7 days, 1 month, 3 months, and 6 months to check Participant’s Perception of Pain with Universal Pain Assessment Tool, Peri-implant crestal bone level, Early Wound Healing Score, Peri-implant Radiolucencies, modified Plaque Index, modified Sulcus Bleeding Index, Peri-implant Mucosal Index, Implant Mobility Index, Peri-implant Sulcus Probing Depth, Peri-implant Clinical Attachment Level, Width of Peri-implant Keratinized Mucosa, Peri-implant Suppuration. DATA ANALYSIS : The data will be analysed statistically with standard analysis of variance at a level of significance of p value < or = 0.05. |